Fertility and Polycystic Ovary Syndrome

NCT07499518 | Not Yet Recruiting

• 1 other identifier: APHP260113
• Study Type: observational
• Target: 473
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polycystic Ovary Syndrome (PCOS)

Keywords

PCOS; Fertility; parental project; pregnancy; hormonal factors; metabolic factors

Outcome Measures

Primary Outcomes (1)

• Description of the mode of conception

  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 Outcomes (3)

• Description of the treatment protocols for infertility

  Through study completion, an average of 1 year

• Description of obstetric complications

  Through study completion, an average of 1 year

• Identification of hormonal and metabolic factors associated with infertility and obstetric complications

  Through study completion, an average of 1 year

Study Arms (2)

PCOS patients

PCOS patients aged between 18 and 45 years

Other: Questionnaires

Control

Control (PCOS free)

Other: Questionnaires

Interventions

Questionnaires OTHER

Questionnaires about fertility and potential pregnancies

Control; PCOS patients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Endocrinology department, Pitié Salpêtrière hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Surveys and Questionnaires

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Anne BACHELOT, MD-PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne BACHELOT, MD, PhD

CONTACT

+33 01 42 16 02 46; anne.bachelot@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

FR (1)