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Fertility and Polycystic Ovary Syndrome

Description of Fertility and Pregnancies in Patients With Polycystic Ovary Syndrome

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07499518
Acronym
FERTIOPK
Enrollment
473
Registered
2026-03-30
Start date
2026-06-01
Completion date
2027-06-01
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome (PCOS)

Keywords

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

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. 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.

Interventions

OTHERQuestionnaires

Questionnaires about fertility and potential pregnancies

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Description of the mode of conceptionThrough study completion, an average of 1 yearDescription 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.

Secondary

MeasureTime frameDescription
Description of the treatment protocols for infertilityThrough study completion, an average of 1 yearDescription 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
Description of obstetric complicationsThrough study completion, an average of 1 yearDescription 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.
Identification of hormonal and metabolic factors associated with infertility and obstetric complicationsThrough study completion, an average of 1 yearIdentify 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

Countries

France

Contacts

CONTACTAnne BACHELOT, MD, PhD
anne.bachelot@aphp.fr+33 01 42 16 02 46
PRINCIPAL_INVESTIGATORAnne BACHELOT, MD-PhD

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026