STUDY QUESTION Can a core outcome set to standardize outcome selection, collection and reporting ... more STUDY QUESTION Can a core outcome set to standardize outcome selection, collection and reporting across future infertility research be developed? SUMMARY ANSWER A minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCTs) and systematic reviews evaluating potential treatments for infertility. WHAT IS KNOWN ALREADY Complex issues, including a failure to consider the perspectives of people with fertility problems when selecting outcomes, variations in outcome definitions and the selective reporting of outcomes on the basis of statistical analysis, make the results of infertility research difficult to interpret. STUDY DESIGN, SIZE, DURATION A three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries). PARTICIPANTS/MATERIALS, SETTING, METHODS Healthcare professionals, researchers and people with fertility problems were brought together in an open and transparent proc...
We aim to produce, disseminate and implement a core outcome set for future infertility research. ... more We aim to produce, disseminate and implement a core outcome set for future infertility research. WHAT IS KNOWN ALREADY: Randomized controlled trials (RCTs) evaluating infertility treatments have reported many different outcomes, which are often defined and measured in different ways. Such variation contributes to an inability to compare, contrast and combine results of individual RCTs. The development of a core outcome set will ensure outcomes important to key stakeholders are consistently collected and reported across future infertility research. STUDY DESIGN, SIZE, DURATION: This is a consensus study using the modified Delphi method. All stakeholders, including healthcare professionals, allied healthcare professionals, researchers and people with lived experience of infertility will be invited to participate. PARTICIPANTS/MATERIALS, SETTING, METHODS: An international steering group, including people with lived experience of infertility, healthcare professionals, allied healthcare professionals and researchers, has been formed to guide the development of this core outcome set. Potential core outcomes have been identified through a comprehensive literature review of RCTs evaluating treatments for infertility and will be entered into a modified Delphi method. Participants will be asked to score potential core outcomes on a nine-point Likert scale anchored between one (not important) and nine (critical). Repeated reflection and rescoring should promote convergence towards consensus 'core' outcomes. We will establish standardized definitions and recommend high-quality measurement instruments for individual core outcomes.
To evaluate the place of ultrasound-directed transvaginal transmyometrial ET in a protocol using ... more To evaluate the place of ultrasound-directed transvaginal transmyometrial ET in a protocol using both the transcervical and transmyometrial routes in a step-wise fashion. A prospective descriptive clinical study. A university-based assisted conception unit. Thirteen patients who had difficult or impossible mock transcervical ET immediately before the real transfer. Ultrasound-directed transvaginal transmyometrial ET. Pregnancy and clinical pregnancy. Four patients became pregnant, including three with clinical pregnancies. In cases in which transcervical ET isd difficult or impossible, transvaginal transmyometrial ET is a viable option. The use of mock transcervical ET immediately before the real transfer would identify patients needing transmyometrial ET.
To assess whether extracellular microRNAs (miRNAs) can be accurately profiled from spent blastocy... more To assess whether extracellular microRNAs (miRNAs) can be accurately profiled from spent blastocyst culture media (SBM) and used as embryonic biomarkers. Design: Prospective cohort study. Setting: Private and academic in vitro fertilization centers. Patient(s): Inner cell mass-free trophectoderm (TE) samples and their relative SBM from five good-quality human blastocysts. Intervention(s): Protocol for miRNA purification and analysis based on quantitative polymerase chain reaction set and validated on human embryonic stem cells (hESCs) and on SBM with and without biological variability. Main Outcomes Measure(s): Analysis of miRNAs in culture media in relation with TE cells and comparison of miRNA profiles between implanted and unimplanted euploid blastocysts. Result(s): Culture media from embryos in the cleavage, morula, and blastocyst stages were collected to investigate the presence of miRNAs. The SBM were prospectively collected from euploid implanted (n ¼ 25) and unimplanted blastocysts (n ¼ 28) for comparison. We hypothesized that human embryos secrete miRNAs in culture media that can be used as biomarkers. The comparative analysis of TE and SBM samples revealed that 96.6% (57 of 59; 95 CI, 88.3-99.6) of the miRNAs detected in the SBM were expressed from TE cells, suggesting a TE origin. The culture media collected from cleavage and morula stage embryos showed a pattern similar to blanks, suggesting that miRNAs profiling from spent culture media applies only for blastocysts. MicroRNAs analysis of SBM from euploid implanted and unimplanted blastocysts highlighted two miRNAs (miR-20a, miR-30c) that showed increased concentrations in the former and were predicted in silico to be involved in 23 implantation-related pathways. Conclusion(s): MicroRNAs secreted from human blastocysts in culture media can be profiled with high reproducibility, and this approach can be further explored for noninvasive embryo selection.
Background Poor response to ovarian stimulation with exogenous gonadotrophins occurs in 9–24% of ... more Background Poor response to ovarian stimulation with exogenous gonadotrophins occurs in 9–24% of women undergoing in vitro fertilisation (IVF) treatment, which represents an estimated 4000–10,000 women per year in the UK. Poor responders often have their treatment cycle cancelled because of expected poor outcome. One treatment strategy that may influence outcome is the choice of pituitary suppression regimen prior to the initiation of ovarian stimulation. The three commonly used pituitary suppression regimens in IVF treatment are: (1) the GnRH agonist long regimen, (2) the GnRH agonist short regimen and (3) the GnRH antagonist regimen. A systematic review of randomised controlled trials of these pituitary suppression regimens has shown the evidence to be either inconclusive or inconsistent. We therefore designed a three arm randomised trial to evaluate the effectiveness of these regimens in women who had poor ovarian response in a previous IVF treatment cycle. Methods/design Consent...
BACKGROUND: Ovarian reserve significantly influences IVF outcome. Low response to ovarian stimula... more BACKGROUND: Ovarian reserve significantly influences IVF outcome. Low response to ovarian stimulation due to reduction of ovarian reserve is occasionally encountered in young women. The aim of this study was to evaluate the outcome of IVF treatment in young patients with reduced ovarian reserve. METHODS AND RESULTS: Between January 1993-2001, 762 consecutive patients satisfied the definition of reduced ovarian reserve (raised early follicular phase FSH or gonadotrophin stimulation cycles where three or fewer oocytes were retrieved after routine FSH stimulation) and were included in the study. They were classified into three age groups: young (≤30 years), intermediate (31-38 years) and older (>38 years). The three age groups were similar with respect to basal (day 3) serum FSH and estradiol concentrations, cause of infertility and number of previous treatment cycles. Implantation (13, 9.6 and 9.8%), clinical pregnancy (11.8, 10.2 and 10%) and live birth (7.4, 7.3 and 6.8%) rates were not significantly different in the three age groups respectively (P > 0.05). CONCLUSION: This study shows that younger patients with reduced ovarian reserve have a poor outcome of IVF treatment similar to their older counterparts. Such information may be helpful in counselling these patients who otherwise might anticipate an outcome related to their chronological age.
Does addition of choriogonadotropin beta (CG beta) to follitropin delta increase the number of go... more Does addition of choriogonadotropin beta (CG beta) to follitropin delta increase the number of good-quality blastocysts following ovarian stimulation in a long GnRH agonist protocol? At the doses investigated, the addition of CG beta reduced the number of intermediate follicles and decreased the number of oocytes and blastocysts. CG beta is a new recombinant hCG (rhCG) molecule expressed by a human cell line (PER.C6â) with a different glycosylation profile compared to urinary hCG or rhCG derived from a Chinese Hamster Ovary (CHO) cell-line. In the first-in-human trial, the CG beta pharmacokinetics were similar between men and women. In women, the area under the curve (AUC) and the peak serum concentration (Cmax) increased dose proportionally following single and multiple daily doses. In men, a single dose of CG beta provided higher exposure with a longer half-life and proportionately higher testosterone production than rhCG derived from a CHO cell line. Placebo-controlled, double-bl...
BACKGROUND The Belgian legislation imposes single embryo transfer (SET) on women of <36 years ... more BACKGROUND The Belgian legislation imposes single embryo transfer (SET) on women of <36 years in their first treatment cycle to avoid multiple pregnancies. The aim of this study is to assess the impact of this legislation on the outcome of preimplantation genetic diagnosis (PGD) for inherited diseases in young women undergoing SET. METHODS A retrospective analysis of PGD cycles for monogenic disorders and translocations in women <36 years on their first treatment cycle. Two groups of patients were defined according to the implementation of the Belgian legislation: (i) double embryo transfer (DET), January 2001-June 2003 (ii) SET, July 2003-June 2005. The primary and secondary outcome measures were delivery per embryo transfer and multiple pregnancy rates, respectively. A subgroup analysis for monogenic disorders and translocations was performed. RESULTS 62 cycles were included in the DET group and 73 cycles in the SET group. The mean age, number of cumulus-oocyte complexes, number of fertilized oocytes, number of biopsied and cryopreserved embryos were comparable between both groups. There was no significant difference in the delivery rates between the DET and the SET groups (33.9% versus 27.4%, respectively). Multiple pregnancies were avoided when SET was performed. When monogenic disorders and chromosomal translocations were separately evaluated, no significant difference in the delivery rate after SET was observed. CONCLUSIONS The implementation of a SET policy in young women undergoing PGD for monogenic disorders and translocations enables a significant reduction of multiple pregnancies without significantly affecting the delivery rate.
Study question Does conception by Preimplantation Genetic Testing (PGT-M, PGT-SR) adversely affec... more Study question Does conception by Preimplantation Genetic Testing (PGT-M, PGT-SR) adversely affect health outcomes in children born through this assisted reproductive technique? Summary answer No significant difference was noted in the rate of congenital malformations in children born after PGT-M and PGT-SR compared with IVF-ICSI children. What is known already It is already known that the risk of congenital anomalies in IVF-ICSI pregnancies is higher when compared with pregnancies conceived naturally. Study design, size, duration This is a prospective study on 747 children born between December 1999 and July 2016 after a cycle of PGT-M or PGT-SR (IVF +/- ICSI + embryo biopsy) performed at a single London reproductive centre. PGT-A is not performed in the Centre, so pregnancy outcomes in this group are not relevant. The children were examined at birth, at 12 and 24 months of age and the data collected in three questionnaires. Participants/materials, setting, methods 747 PGT-M and PG...
Executive Committee. Guidelines on therapeutic products to treat haemophilia and other hereditary... more Executive Committee. Guidelines on therapeutic products to treat haemophilia and other hereditary disorders.
BACKGROUND: Although uterine fibroids occur in 30% of women and are associated with a degree of s... more BACKGROUND: Although uterine fibroids occur in 30% of women and are associated with a degree of subfertility, the effect of intramural fibroids on the outcome of IVF or ICSI treatment has not been prospectively studied. METHODS: Data were prospectively collected on 434 women undergoing IVF/ICSI in the assisted conception unit of an inner London teaching hospital. Patients were assessed for the presence of fibroids by transvaginal ultrasound and hysterosonography or hysteroscopy where appropriate. RESULTS: During the study period, 112 women with (study), and 322 women without (controls), intramural fibroids were treated. Patients were similar regarding the cause and duration of their infertility, number of previous treatments, and basal serum FSH concentration. Women in the study group were on average 2 years older (36.4 versus 34.6 years; P < 0.01). There was no significant difference in the duration of ovarian stimulation or gonadotrophin requirement, number of follicles developed, oocytes collected, embryos available for transfer or replaced. When analysing only women with intramural fibroids of ≤5 cm in size (n ⍧ 106) pregnancy, implantation and ongoing pregnancy rates were significantly reduced: 23.3, 11.9 and 15.1 respectively compared with 34.1, 20.2 and 28.3% in the control group (P ⍧ 0.016, P ϭ 0.018 and P ⍧ 0.003). The mean size of the largest fibroids was 2.3 cm (90% range 2.1-2.5 cm). Logistic regression analysis demonstrated that the presence of intramural fibroids was one of the significant variables affecting the chance of an ongoing pregnancy, even after controlling for the number of embryos available for replacement and increasing age, particularly age ≥40 years, odds ratio 0.46 (CI 0.24-0.88; P ⍧ 0.019). CONCLUSION: This study demonstrated that an intramural fibroid halves the chances of an ongoing pregnancy following assisted conception.
Background and objectivesProgesterone is essential to maintain a healthy pregnancy. Guidance from... more Background and objectivesProgesterone is essential to maintain a healthy pregnancy. Guidance from the Royal College of Obstetricians and Gynaecologists and a Cochrane review called for a definitive trial to test whether or not progesterone therapy in the first trimester could reduce the risk of miscarriage in women with a history of unexplained recurrent miscarriage (RM). The PROMISE trial was conducted to answer this question. A concurrent cost-effectiveness analysis was conducted.Design and settingA randomised, double-blind, placebo-controlled, international multicentre study, with economic evaluation, conducted in hospital settings across the UK (36 sites) and in the Netherlands (nine sites).Participants and interventionsWomen with unexplained RM (three or more first-trimester losses), aged between 18 and 39 years at randomisation, conceiving naturally and giving informed consent, received either micronised progesterone (Utrogestan®, Besins Healthcare) at a dose of 400 mg (two va...
STUDY QUESTION Can a core outcome set to standardize outcome selection, collection and reporting ... more STUDY QUESTION Can a core outcome set to standardize outcome selection, collection and reporting across future infertility research be developed? SUMMARY ANSWER A minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCTs) and systematic reviews evaluating potential treatments for infertility. WHAT IS KNOWN ALREADY Complex issues, including a failure to consider the perspectives of people with fertility problems when selecting outcomes, variations in outcome definitions and the selective reporting of outcomes on the basis of statistical analysis, make the results of infertility research difficult to interpret. STUDY DESIGN, SIZE, DURATION A three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries). PARTICIPANTS/MATERIALS, SETTING, METHODS Healthcare professionals, researchers and people with fertility problems were brought together in an open and transparent proc...
We aim to produce, disseminate and implement a core outcome set for future infertility research. ... more We aim to produce, disseminate and implement a core outcome set for future infertility research. WHAT IS KNOWN ALREADY: Randomized controlled trials (RCTs) evaluating infertility treatments have reported many different outcomes, which are often defined and measured in different ways. Such variation contributes to an inability to compare, contrast and combine results of individual RCTs. The development of a core outcome set will ensure outcomes important to key stakeholders are consistently collected and reported across future infertility research. STUDY DESIGN, SIZE, DURATION: This is a consensus study using the modified Delphi method. All stakeholders, including healthcare professionals, allied healthcare professionals, researchers and people with lived experience of infertility will be invited to participate. PARTICIPANTS/MATERIALS, SETTING, METHODS: An international steering group, including people with lived experience of infertility, healthcare professionals, allied healthcare professionals and researchers, has been formed to guide the development of this core outcome set. Potential core outcomes have been identified through a comprehensive literature review of RCTs evaluating treatments for infertility and will be entered into a modified Delphi method. Participants will be asked to score potential core outcomes on a nine-point Likert scale anchored between one (not important) and nine (critical). Repeated reflection and rescoring should promote convergence towards consensus 'core' outcomes. We will establish standardized definitions and recommend high-quality measurement instruments for individual core outcomes.
To evaluate the place of ultrasound-directed transvaginal transmyometrial ET in a protocol using ... more To evaluate the place of ultrasound-directed transvaginal transmyometrial ET in a protocol using both the transcervical and transmyometrial routes in a step-wise fashion. A prospective descriptive clinical study. A university-based assisted conception unit. Thirteen patients who had difficult or impossible mock transcervical ET immediately before the real transfer. Ultrasound-directed transvaginal transmyometrial ET. Pregnancy and clinical pregnancy. Four patients became pregnant, including three with clinical pregnancies. In cases in which transcervical ET isd difficult or impossible, transvaginal transmyometrial ET is a viable option. The use of mock transcervical ET immediately before the real transfer would identify patients needing transmyometrial ET.
To assess whether extracellular microRNAs (miRNAs) can be accurately profiled from spent blastocy... more To assess whether extracellular microRNAs (miRNAs) can be accurately profiled from spent blastocyst culture media (SBM) and used as embryonic biomarkers. Design: Prospective cohort study. Setting: Private and academic in vitro fertilization centers. Patient(s): Inner cell mass-free trophectoderm (TE) samples and their relative SBM from five good-quality human blastocysts. Intervention(s): Protocol for miRNA purification and analysis based on quantitative polymerase chain reaction set and validated on human embryonic stem cells (hESCs) and on SBM with and without biological variability. Main Outcomes Measure(s): Analysis of miRNAs in culture media in relation with TE cells and comparison of miRNA profiles between implanted and unimplanted euploid blastocysts. Result(s): Culture media from embryos in the cleavage, morula, and blastocyst stages were collected to investigate the presence of miRNAs. The SBM were prospectively collected from euploid implanted (n ¼ 25) and unimplanted blastocysts (n ¼ 28) for comparison. We hypothesized that human embryos secrete miRNAs in culture media that can be used as biomarkers. The comparative analysis of TE and SBM samples revealed that 96.6% (57 of 59; 95 CI, 88.3-99.6) of the miRNAs detected in the SBM were expressed from TE cells, suggesting a TE origin. The culture media collected from cleavage and morula stage embryos showed a pattern similar to blanks, suggesting that miRNAs profiling from spent culture media applies only for blastocysts. MicroRNAs analysis of SBM from euploid implanted and unimplanted blastocysts highlighted two miRNAs (miR-20a, miR-30c) that showed increased concentrations in the former and were predicted in silico to be involved in 23 implantation-related pathways. Conclusion(s): MicroRNAs secreted from human blastocysts in culture media can be profiled with high reproducibility, and this approach can be further explored for noninvasive embryo selection.
Background Poor response to ovarian stimulation with exogenous gonadotrophins occurs in 9–24% of ... more Background Poor response to ovarian stimulation with exogenous gonadotrophins occurs in 9–24% of women undergoing in vitro fertilisation (IVF) treatment, which represents an estimated 4000–10,000 women per year in the UK. Poor responders often have their treatment cycle cancelled because of expected poor outcome. One treatment strategy that may influence outcome is the choice of pituitary suppression regimen prior to the initiation of ovarian stimulation. The three commonly used pituitary suppression regimens in IVF treatment are: (1) the GnRH agonist long regimen, (2) the GnRH agonist short regimen and (3) the GnRH antagonist regimen. A systematic review of randomised controlled trials of these pituitary suppression regimens has shown the evidence to be either inconclusive or inconsistent. We therefore designed a three arm randomised trial to evaluate the effectiveness of these regimens in women who had poor ovarian response in a previous IVF treatment cycle. Methods/design Consent...
BACKGROUND: Ovarian reserve significantly influences IVF outcome. Low response to ovarian stimula... more BACKGROUND: Ovarian reserve significantly influences IVF outcome. Low response to ovarian stimulation due to reduction of ovarian reserve is occasionally encountered in young women. The aim of this study was to evaluate the outcome of IVF treatment in young patients with reduced ovarian reserve. METHODS AND RESULTS: Between January 1993-2001, 762 consecutive patients satisfied the definition of reduced ovarian reserve (raised early follicular phase FSH or gonadotrophin stimulation cycles where three or fewer oocytes were retrieved after routine FSH stimulation) and were included in the study. They were classified into three age groups: young (≤30 years), intermediate (31-38 years) and older (>38 years). The three age groups were similar with respect to basal (day 3) serum FSH and estradiol concentrations, cause of infertility and number of previous treatment cycles. Implantation (13, 9.6 and 9.8%), clinical pregnancy (11.8, 10.2 and 10%) and live birth (7.4, 7.3 and 6.8%) rates were not significantly different in the three age groups respectively (P > 0.05). CONCLUSION: This study shows that younger patients with reduced ovarian reserve have a poor outcome of IVF treatment similar to their older counterparts. Such information may be helpful in counselling these patients who otherwise might anticipate an outcome related to their chronological age.
Does addition of choriogonadotropin beta (CG beta) to follitropin delta increase the number of go... more Does addition of choriogonadotropin beta (CG beta) to follitropin delta increase the number of good-quality blastocysts following ovarian stimulation in a long GnRH agonist protocol? At the doses investigated, the addition of CG beta reduced the number of intermediate follicles and decreased the number of oocytes and blastocysts. CG beta is a new recombinant hCG (rhCG) molecule expressed by a human cell line (PER.C6â) with a different glycosylation profile compared to urinary hCG or rhCG derived from a Chinese Hamster Ovary (CHO) cell-line. In the first-in-human trial, the CG beta pharmacokinetics were similar between men and women. In women, the area under the curve (AUC) and the peak serum concentration (Cmax) increased dose proportionally following single and multiple daily doses. In men, a single dose of CG beta provided higher exposure with a longer half-life and proportionately higher testosterone production than rhCG derived from a CHO cell line. Placebo-controlled, double-bl...
BACKGROUND The Belgian legislation imposes single embryo transfer (SET) on women of <36 years ... more BACKGROUND The Belgian legislation imposes single embryo transfer (SET) on women of <36 years in their first treatment cycle to avoid multiple pregnancies. The aim of this study is to assess the impact of this legislation on the outcome of preimplantation genetic diagnosis (PGD) for inherited diseases in young women undergoing SET. METHODS A retrospective analysis of PGD cycles for monogenic disorders and translocations in women <36 years on their first treatment cycle. Two groups of patients were defined according to the implementation of the Belgian legislation: (i) double embryo transfer (DET), January 2001-June 2003 (ii) SET, July 2003-June 2005. The primary and secondary outcome measures were delivery per embryo transfer and multiple pregnancy rates, respectively. A subgroup analysis for monogenic disorders and translocations was performed. RESULTS 62 cycles were included in the DET group and 73 cycles in the SET group. The mean age, number of cumulus-oocyte complexes, number of fertilized oocytes, number of biopsied and cryopreserved embryos were comparable between both groups. There was no significant difference in the delivery rates between the DET and the SET groups (33.9% versus 27.4%, respectively). Multiple pregnancies were avoided when SET was performed. When monogenic disorders and chromosomal translocations were separately evaluated, no significant difference in the delivery rate after SET was observed. CONCLUSIONS The implementation of a SET policy in young women undergoing PGD for monogenic disorders and translocations enables a significant reduction of multiple pregnancies without significantly affecting the delivery rate.
Study question Does conception by Preimplantation Genetic Testing (PGT-M, PGT-SR) adversely affec... more Study question Does conception by Preimplantation Genetic Testing (PGT-M, PGT-SR) adversely affect health outcomes in children born through this assisted reproductive technique? Summary answer No significant difference was noted in the rate of congenital malformations in children born after PGT-M and PGT-SR compared with IVF-ICSI children. What is known already It is already known that the risk of congenital anomalies in IVF-ICSI pregnancies is higher when compared with pregnancies conceived naturally. Study design, size, duration This is a prospective study on 747 children born between December 1999 and July 2016 after a cycle of PGT-M or PGT-SR (IVF +/- ICSI + embryo biopsy) performed at a single London reproductive centre. PGT-A is not performed in the Centre, so pregnancy outcomes in this group are not relevant. The children were examined at birth, at 12 and 24 months of age and the data collected in three questionnaires. Participants/materials, setting, methods 747 PGT-M and PG...
Executive Committee. Guidelines on therapeutic products to treat haemophilia and other hereditary... more Executive Committee. Guidelines on therapeutic products to treat haemophilia and other hereditary disorders.
BACKGROUND: Although uterine fibroids occur in 30% of women and are associated with a degree of s... more BACKGROUND: Although uterine fibroids occur in 30% of women and are associated with a degree of subfertility, the effect of intramural fibroids on the outcome of IVF or ICSI treatment has not been prospectively studied. METHODS: Data were prospectively collected on 434 women undergoing IVF/ICSI in the assisted conception unit of an inner London teaching hospital. Patients were assessed for the presence of fibroids by transvaginal ultrasound and hysterosonography or hysteroscopy where appropriate. RESULTS: During the study period, 112 women with (study), and 322 women without (controls), intramural fibroids were treated. Patients were similar regarding the cause and duration of their infertility, number of previous treatments, and basal serum FSH concentration. Women in the study group were on average 2 years older (36.4 versus 34.6 years; P < 0.01). There was no significant difference in the duration of ovarian stimulation or gonadotrophin requirement, number of follicles developed, oocytes collected, embryos available for transfer or replaced. When analysing only women with intramural fibroids of ≤5 cm in size (n ⍧ 106) pregnancy, implantation and ongoing pregnancy rates were significantly reduced: 23.3, 11.9 and 15.1 respectively compared with 34.1, 20.2 and 28.3% in the control group (P ⍧ 0.016, P ϭ 0.018 and P ⍧ 0.003). The mean size of the largest fibroids was 2.3 cm (90% range 2.1-2.5 cm). Logistic regression analysis demonstrated that the presence of intramural fibroids was one of the significant variables affecting the chance of an ongoing pregnancy, even after controlling for the number of embryos available for replacement and increasing age, particularly age ≥40 years, odds ratio 0.46 (CI 0.24-0.88; P ⍧ 0.019). CONCLUSION: This study demonstrated that an intramural fibroid halves the chances of an ongoing pregnancy following assisted conception.
Background and objectivesProgesterone is essential to maintain a healthy pregnancy. Guidance from... more Background and objectivesProgesterone is essential to maintain a healthy pregnancy. Guidance from the Royal College of Obstetricians and Gynaecologists and a Cochrane review called for a definitive trial to test whether or not progesterone therapy in the first trimester could reduce the risk of miscarriage in women with a history of unexplained recurrent miscarriage (RM). The PROMISE trial was conducted to answer this question. A concurrent cost-effectiveness analysis was conducted.Design and settingA randomised, double-blind, placebo-controlled, international multicentre study, with economic evaluation, conducted in hospital settings across the UK (36 sites) and in the Netherlands (nine sites).Participants and interventionsWomen with unexplained RM (three or more first-trimester losses), aged between 18 and 39 years at randomisation, conceiving naturally and giving informed consent, received either micronised progesterone (Utrogestan®, Besins Healthcare) at a dose of 400 mg (two va...
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