Effect of Hyperandrogenism on IVF Outcomes in PCOS Patients (HIP)

Ovo Clinic

Status: Terminated

Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Treatments: Other: Ferriman-Gallwey Score

Study type: Observational

Funder types: Industry

Identifiers

NCT05555680

CCER 21-22 - 31

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

32 participants in 2 patient groups

PCOS patients with clinical or biochemical hyperandrogenism

Description:

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.

Treatment:

Other: Ferriman-Gallwey Score

PCOS patients with no clinical or biochemical hyperandrogenism

Description:

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

Treatment:

Other: Ferriman-Gallwey Score