Fertility and Polycystic Ovary Syndrome (FERTIOPK)

June 8, 2026 updated by: Assistance Publique - Hôpitaux de Paris

Description of Fertility and Pregnancies in Patients With Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder among women of reproductive age and affects approximately 10% of women worldwide. The diagnosis is based on the Rotterdam criteria established in 2003 and updated in the latest recommendations from the European Society of Human Reproduction (ESHRE) in 2023. The diagnosis of PCOS is based on the presence of 2 of the following 3 criteria:

  1. Oligo-anovulation
  2. Clinical and/or biological hyperandrogenism
  3. Polycystic ovary morphology (PCOM) on imaging It is also the leading cause of anovulatory infertility, with a 15-fold increased risk of infertility.

It is therefore a major cause of anovulatory infertility, but its pathophysiological mechanisms remain complex and multifactorial, involving interactions between genetic, metabolic, hormonal, and environmental factors. Prior to embarking on a fertility treatment plan, it is essential to better understand how these various factors influence ovarian function and reproductive capacity in patients with PCOS. Identifying and characterizing factors associated with fertility-such as hormonal profiles, insulin sensitivity, and metabolic markers-could help better predict future fertility and optimize personalized care and fertility outcomes. The aim of this study is therefore to identify modifiable factors influencing the fertility of PCOS patients phenotyped at La Pitié-Salpêtrière hospital.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

473

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Paris, France, 75013
        • Endocrinology department, Pitié Salpêtrière hospital
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

PCOS patients and healthy PCOS-free participants previously enrolled in METABOPK research at Pitié-Salpêtrière hospital

Description

Inclusion Criteria- PCOS group:

  • Aged between 18 and 45 years old
  • Female with a diagnosis of PCOS according to ESHRE criteria
  • Previouslu enrolled in METABOPK research

Inclusion Criteria- Control group

  • Aged between 18 and 45 years old
  • Female with normal metabolic and hormonal profiles
  • Previouslu enrolled in METABOPK research

Exclusion Criteria:

  • A prior diagnosis of type 1 or type 2 diabetes
  • A diagnosis of non-classical adrenal block
  • Use of hormonal therapy, oral antidiabetic medication, lipid-lowering medication, antihypertensive medication, corticosteroids, or spironolactone
  • Menopause or current pregnancy
  • Lack of data on BMI, insulin levels, and fasting blood glucose
  • Patients who do not speak French
  • Patients under legal guardianship, conservatorship, or curatorship

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PCOS patients
PCOS patients aged between 18 and 45 years
Other: Questionnaires
Questionnaires about fertility and potential pregnancies
Control
Control (PCOS free)
Other: Questionnaires
Questionnaires about fertility and potential pregnancies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of the mode of conception
Time Frame: Through study completion, an average of 1 year
Description of the mode of conception: spontaneous or induced; if induced, by which ART technique or following which treatment to improve PCOS symptoms (inositol, GLP-1 analog, metformin, lifestyle and dietary changes, etc.). These informations will be colected from medical records and frome the specific questionnaire.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of the treatment protocols for infertility
Time Frame: Through study completion, an average of 1 year

Description of the treatment protocols for infertility among women in the cohort, if applicable:

The description of infertility will be based on patient reports and treatment records
Through study completion, an average of 1 year
Description of obstetric complications
Time Frame: Through study completion, an average of 1 year

Description of obstetric complications: ectopic pregnancy, miscarriage, intrauterine fetal death, intrauterine growth restriction (IUGR), gestational diabetes, hypertension, preeclampsia, HELLP syndrome, intrahepatic cholestasis of pregnancy, gestational age at delivery, spontaneous or induced labor, birth weight, breastfeeding possible if desired:

The description of obstetric complications will be based on data from the specific questionnaire and from pregnancy and delivery follow-up reports.
Through study completion, an average of 1 year
Identification of hormonal and metabolic factors associated with infertility and obstetric complications
Time Frame: Through study completion, an average of 1 year
Identify hormonal and metabolic factors associated with infertility and obstetric complications early on so that appropriate measures can be taken in preparation for starting a family
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Anne BACHELOT, MD-PhD, Assistance Publique - Hôpitaux de Paris

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 (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP260113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

IPD Sharing Time Frame

Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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