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

December 3, 2025 updated by: Clinique Ovo

Effect of Hyperandrogenism on IVF Success Rates in PCOS Patients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4P 2S4
        • Clinique ovo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

N/A

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effect of hyperandrogenism on frozen embryo transfer
Time Frame: 10 days after 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Ovo

Investigators

  • Principal Investigator: Joanne Benoit, MD, Clinique ovo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2022

Primary Completion (Actual)

January 29, 2025

Study Completion (Actual)

January 29, 2025

Study Registration Dates

First Submitted

September 22, 2022

First Submitted That Met QC Criteria

September 22, 2022

First Posted (Actual)

September 27, 2022

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCER 21-22 - 31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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