How should we report outcomes in reproductive medicine?

Gadalla, Moustafa Abdelhafez; Wang, Rui; Wely, Madelon van; Mol, Ben Willem J.

doi:10.1002/uog.18969

Cited by 11 publications

(5 citation statements)

References 27 publications

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“…The ultimate objective of ART is to achieve a healthy live birth. In this context, it has been suggested that the main outcome measure for reproductive medicine should be the live birth rates or ongoing clinical pregnancy rates [24][25][26][27][28][29][30]. However, in the case of multicenter trials to compare the therapeutic effects of different medications, it is important to consider that there could be unquantifiable biases and confounding factors that originate from patients (e.g., sperm quality, endometrial thickness) or procedures following oocyte collection (e.g., fertilization, embryo culture).…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of recombinant human follicle-stimulating hormone in patients undergoing in vitro fertilization-embryo transfer

Song

et al. 2020

Aging

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To compare the ovarian responses after administration of two recombinant follicle-stimulating hormone (r-FSH) preparations under gonadotropin-releasing hormone (GnRH) analogue downregulation, we conducted a phase 3, randomized, multicenter, assessor-blind, active-controlled, parallel group study. The primary outcome was the number of oocytes retrieved. The secondary outcomes included total dose and duration of r-FSH administered, oocyte quality, blood estradiol levels, follicular development, fertilization rates, implantation rates, and pregnancy rates (biochemical, clinical, and ongoing). A total of 451 patients with infertility were randomized to receive either Follitrope™ Prefilled Syringe or Gonal-F ® Pen for ovarian stimulation. The mean number of oocytes retrieved was 14.9 in the Follitrope TM Prefilled Syringe group, and 12.8 in the Gonal-F ® Pen group. The 95% confidence interval in the oocyte number difference between the groups was [-0.1, 4.2], demonstrating that Follitrope TM Prefilled Syringe was not inferior to Gonal-F ® Pen. The clinical pregnancy rates (Follitrope TM Prefilled Syringe vs. Gonal-F ® Pen: 55.4% vs. 51.9%) and ongoing pregnancy rates (44.1% vs. 43.0%) were similar between the groups. No clinically significant adverse events were observed in either group. In summary, our study indicates that Follitrope TM Prefilled Syringe is safe and efficacious for ovarian stimulation.

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of recombinant human follicle-stimulating hormone in patients undergoing in vitro fertilization-embryo transfer

Song

et al. 2020

Aging

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“…In addition, unlike many studies in the field of reproductive medicine that report gestational rates, we chose LBR to consider pregnancy losses. 18 The LBRs for all treatments were considerably high, which is probably a consequence of ours being a population with no infertility background. Almost three in four couples had at least one LB.…”

Section: Discussionmentioning

confidence: 84%

“…In addition, unlike many studies in the field of reproductive medicine that report gestational rates, we chose LBR to consider pregnancy losses. 18 …”

Section: Discussionmentioning

confidence: 99%

The Pathway of Female Couples in a Fertility Clinic

Brandão

Ceschin²,

Gómez

2022

Rev Bras Ginecol Obstet

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Objective The present study aims to describe the main characteristics of female couples resorting to a fertility clinic, to understand whether these patients have clear previous plans concerning procreation and how they end up completing their family planning, and to briefly describe the main outcomes of the recepción de ovocitos de pareja (ROPA, in the Spanish acronym: in English, reception of partner's oocytes) method. Methods This is a descriptive retrospective study of the pathway and outcomes of female couples in a fertility clinic during a 2-year period. Results A total of 129 couples were treated. Only one third of the couples had no condition potentially affecting fertility or advanced age. Most couples were decided to undergo artificial insemination or in vitro fertilization and the majority kept their plans, as opposed to 38% of the couples who decided to the ROPA method (lesbian shared in vitro fertilization) who changed plans. Live birth rates per treatment (including frozen embryo transfers) for artificial insemination, 58% for in vitro fertilization, 80% for treatments with donated oocytes or embryos, and 79% for ROPA. Four in five couples achieved live births. Conclusion The present study highlights the importance of a thorough medical workup in same-sex couples resorting to assisted reproduction. Despite the higher-than-expected rates of fertility disorders, the outcomes were good. Most couples end up in a single parented method. Furthermore, the results of the ROPA method are reassuring.

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“…Outcome reporting in reproductive medicine studies is a wider and long-standing area of debate ( Clarke et al , 2010 ; Barnhart, 2014 ; Braakhekke et al , 2014 ; Gadalla et al , 2018 ). Different research groups have varying opinions on what pregnancy outcome is the most meaningful within a trial setting ( Clarke et al , 2010 ; Barnhart, 2014 ; Braakhekke et al , 2014 ; Gadalla et al , 2018 ). In 2003, ESHRE recommended that the outcome measure for ART and non-ART should be ‘singleton live birth rate’ ( Land and Evers, 2003 ).…”

Section: Discussionmentioning

confidence: 99%

Endometrial compaction to predict pregnancy outcomes in patients undergoing assisted reproductive technologies: a systematic review and meta-analysis

Al-Lamee,

Stone,

Powell

et al. 2024

Human Reproduction Open

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STUDY QUESTION Does endometrial compaction (EC) help predict pregnancy outcomes in those undergoing ART? SUMMARY ANSWER EC is associated with a significantly higher clinical pregnancy rate (CPR) and ongoing pregnancy rate (OPR), but this does not translate to live birth rate (LBR). WHAT IS KNOWN ALREADY EC describes the progesterone-induced decrease in endometrial thickness, which may be observed following the end of the proliferative phase, prior to embryo transfer. EC is proposed as a non-invasive tool to help predict pregnancy outcome in those undergoing ART, however published data is conflicting. STUDY DESIGN, SIZE, DURATION A literature search was carried out by two independent authors using PubMed, Cochrane Library, MEDLINE, Embase, Science Direct, Scopus and Web of Science from inception of databases to May 2023. All peer-reviewed studies reporting EC and pregnancy outcomes in patients undergoing IVF/ICSI treatment were included. PARTICIPANTS/MATERIALS, SETTING, METHODS The primary outcome is LBR. Secondary outcomes included other pregnancy metrics (positive pregnancy test (PPT), CPR, OPR, miscarriage rate (MR)) and rate of EC. Comparative meta-analyses comparing EC and no EC were conducted for each outcome using a random-effects model if I2>50%. The Mantel-Haenszel method was applied for pooling dichotomous data. Results are presented as odds ratios (OR) with 95% CI. MAIN RESULTS AND THE ROLE OF CHANCE Out of 4,030 screened articles, 21 cohort studies were included in the final analysis (n = 27,857). No significant difference was found between LBR in the EC versus the no EC group (OR 0.95; 95% CI 0.87-1.04). OPR was significantly higher within the EC group (OR 1.61; 95% CI 1.09- 2.38), particularly when EC ≥ 15% compared to no EC (OR 3.52; 95% CI 2.36-5.23). CPR was inconsistently defined across the studies, affecting the findings. When defined as a viable intrauterine pregnancy <12 weeks, EC group had significantly higher CPR than no EC (OR 1.83; 95% CI 1.15-2.92). No significant differences were found between EC and no EC for PPT (OR 1.54; 95% CI 0.97-2.45) or MR (OR 1.06; 95% CI 0.92-1.56). The pooled weighted incidence of EC across all studies was 32% (95% CI 26-38%). LIMITATIONS, REASONS FOR CAUTION Heterogeneity due to differences between reported pregnancy outcomes, definition of EC, method of ultrasound and cycle protocol, may account for the lack of translation between CPR/OPR and LBR findings, thus, all pooled data should be viewed with an element of caution. WIDER IMPLICATIONS OF THE FINDINGS In this dataset, the significantly higher CPR/OPR with EC does not translate to LBR. Although stratification of women according to EC cannot currently be recommended in clinical practice, a large and well-designed clinical trial to rigorously assess EC as a non-invasive predictor of a successful pregnancy is warranted. We urge for consistent outcome reporting to be mandated for ART trials so that data can be pooled, compared, and concluded on. STUDY FUNDING/COMPETING INTEREST(S) H.A. is supported by the Hewitt Fertility Centre. S.G.P. and J.W. are supported by the Liverpool University Hospital NHS Foundation Trust. D.K.H. is supported by a Wellbeing of Women project grant (RG2137) and MRC clinical research training fellowship (MR/V007238/1). NT is supported by the National Institute for Health and Care Research. D.K.H. has received honoraria for consultancy for Theramex and has received payment for presentations from Theramex and Gideon Richter. The remaining authors have no conflicts of interests to report. REGISTRATION NUMBER PROSPERO CRD42022378464

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How should we report outcomes in reproductive medicine?

Cited by 11 publications

References 27 publications

Efficacy and safety of recombinant human follicle-stimulating hormone in patients undergoing in vitro fertilization-embryo transfer

Efficacy and safety of recombinant human follicle-stimulating hormone in patients undergoing in vitro fertilization-embryo transfer

The Pathway of Female Couples in a Fertility Clinic

Endometrial compaction to predict pregnancy outcomes in patients undergoing assisted reproductive technologies: a systematic review and meta-analysis

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