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Effect of Hyperandrogenism on IVF Outcomes in PCOS Patients

Effect of Hyperandrogenism on IVF Success Rates in PCOS Patients

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05555680
Acronym
HIP
Enrollment
32
Registered
2022-09-27
Start date
2022-01-21
Completion date
2025-01-29
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Keywords

Hyperandrogenism, Fertility issues

Brief summary

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.

Detailed description

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.

Interventions

OTHERFerriman-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

Sponsors

Clinique Ovo
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 39 Years

Inclusion criteria

* Women between ages of 18 - 39 inclusively * ≥15 oocytes collected on the day of oocyte retrieval and/or anti-mullerian hormone (AMH) ≥ 4.0 ng/ml in the participant's medical chart in the last 24 months

Exclusion criteria

* Male factor necessitating testicular sperm aspiration (TESA), testicular sperm extraction (TESE) or micro-TESE * Fertility preservation * Recurrent pregnancy losses (RPL) (defined as 2 or more failed clinical pregnancies as documented by ultrasonography or histopathologic examination,or 3 or more failed pregnancies before 14 weeks of gestation) * Oocyte donation * Medical diagnosis of non classic congenital adrenal hyperplasia diagnosed based on 17 hydroxyprogesterone level

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the effect of hyperandrogenism on frozen embryo transfer10 days after frozen embryo transferDetermine the effect of PCOS subjects affected by hyperandrogenism (HA) on clinical pregnancy rate following a frozen embryo transfer

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026