An observational study in PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, sponsored by Clinique Ovo. Terminated at 1 site in Canada. Open to female participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Clinique Ovo · Observational
Ovulatory dysfunction affects 18 to 25% of infertile women, the most common identifiable condition is polycystic ovarian syndrome (PCOS). The most frequent symptoms of PCOS are oligo-anovulation, hyperandrogenism and polycystic ovary appearance.
Hyperandrogenism is the main contributor that affects oocyte and embryo quality and decreases the success rates in PCOS patients undergoing IVF treatments.
The aim of this study is to determine the effect of hyperandrogenism as an independent factor on IVF success rates and oocyte/embryo quality in PCOS patients undergoing IVF.
Despite that PCOS patients obtain a higher yield of oocytes retrieved in IVF treatments, they often have lower fertilization, cleavage and implantation rates and a higher rate of miscarriage, which can be attributed to a poor quality of retrieved oocytes and the resulting embryos. Multiple studies compared IVF outcomes in PCOS patients to control groups and found that PCOS might negatively affect oocyte maturation rate, fertilization rate in conventional IVF and miscarriage rate. Hence, it seems that PCOS might be associated with poor outcomes in IVF cycles when compared to non-PCOS patients.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's enrollment of 32 is below the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Clinique Ovo is the lead sponsor of 36 studies on the registry; 1 is open to participants now.
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PCOS patients undergoing the first embryo transfer following the first IVF treatment during the study period (or up to two embryo transfers)
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Exclusion Criteria:
Clinical hyperandrogenism consists of patients with one of the following conditions: Acne, Hirsutism (using modified Ferriman-Gallwey (FG) score) or Androgenic alopecia Biochemical hyperandrogenism consists of elevated serum level of at least one of the following hormones: Total testosterone, free testosterone, DHEAS, androstenedione using the cut-offs adopted by the laboratory.
Other: Ferriman-Gallwey Score
In this cohort, women have not be affected by either clinical of biochemical hyperandrogenism. The PCOS diagnosis will be based on oligo-anovulation and on polycystic ovaries during an ultrasound
Other: Ferriman-Gallwey Score
The Ferriman-Gallwey score is used to evaluate hirsutism. The examiner scores the subjects on a scale of 0-4 for terminal hair growth on eleven different body areas according to the Ferriman-Gallwey scoring system. A Ferriman-Gallwey score of 8 or more was considered diagnostic of hirsutism
Evaluate the effect of hyperandrogenism on frozen embryo transfer
Determine the effect of PCOS subjects affected by hyperandrogenism (HA) on clinical pregnancy rate following a frozen embryo transfer
Time frame: 10 days after frozen embryo transfer
Plan to share: No
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Ran from Jan 2022 to primary completion in Jan 2025, 36 months.
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This study is terminated, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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