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TerminatedNCT05555680HIPUpdated Dec 9, 2025

Effect of Hyperandrogenism on IVF Outcomes in PCOS Patients

An observational study in PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, sponsored by Clinique Ovo. Terminated at 1 site in Canada. Open to female participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2025-12-09.

Sponsored by Clinique Ovo · Observational

Why this study was terminated
Low recruitment rate
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
32
Ages
18 Years to 39 Years
Sex
Female
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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.

Read the 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.

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Conditions studied

  • PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Keywords

  • Hyperandrogenism
  • Fertility issues
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In context

Polycystic Ovary Syndrome

956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.

This study's enrollment of 32 is below the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Clinique Ovo is the lead sponsor of 36 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
Female
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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
32 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

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What researchers measure

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

    Time frame: 10 days after frozen embryo transfer

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Study locations

1 site
  • Clinique Ovo
    Montreal, Quebec H4P 2S4, Canada
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2022 to primary completion in Jan 2025, 36 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 22, 2022
First posted
Sep 27, 2022
StartActual
Jan 21, 2022
Primary completionActual
Jan 29, 2025
CompletionActual
Jan 29, 2025
Last update
Dec 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05555680
Lead sponsor
Clinique Ovo
Responsible party
Sponsor
First posted
Sep 27, 2022
Start date
Jan 21, 2022
Primary completion
Jan 29, 2025
Completion
Jan 29, 2025
Last update
Dec 9, 2025

Study contacts

Joanne Benoit, MD
principal investigator · Clinique Ovo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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