Effect of Hyperandrogenism on IVF Outcomes in PCOS Patients

Last updated: October 30, 2023
Sponsor: Clinique Ovo
Overall Status: Active - Recruiting

Phase

N/A

Condition

Testotoxicosis

Reproductive Health

Testotoxikose

Treatment

Ferriman-Gallwey Score

Clinical Study ID

NCT05555680
CCER 21-22 - 31
  • Ages 18-39
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

Study Design

Total Participants: 188
Treatment Group(s): 1
Primary Treatment: Ferriman-Gallwey Score
Phase:
Study Start date:
January 21, 2022
Estimated Completion Date:
December 30, 2025

Study 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.

Connect with a study center

  • Clinique Ovo

    Montreal, Quebec H4P 2S4
    Canada

    Active - Recruiting

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