Effect of Hyperandrogenism on IVF Outcomes in PCOS Patients

NCT05555680 | Terminated

• 1 other identifier: CCER 21-22 - 31
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Keywords

Hyperandrogenism; Fertility issues

Outcome Measures

Primary Outcomes (1)

• 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

  10 days after frozen embryo transfer

Study Arms (2)

PCOS patients with clinical or biochemical hyperandrogenism

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

PCOS patients with no clinical or biochemical hyperandrogenism

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

Interventions

Ferriman-Gallwey Score OTHER

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

PCOS patients with clinical or biochemical hyperandrogenism; PCOS patients with no clinical or biochemical hyperandrogenism

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

PCOS patients undergoing the first embryo transfer following the first IVF treatment during the study period (or up to two embryo transfers)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Ovo: lead

Study Sites (1)

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Hyperandrogenism; Infertility

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Joanne Benoit, MD

  Clinique Ovo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: January 21, 2022
• Primary Completion: January 29, 2025
• Study Completion: January 29, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)