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NCT Number: NCT07499518

Fertility and 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.

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Key information

Conditions

Polycystic Ovary Syndrome (PCOS) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Endocrinology department, Pitié Salpêtrière hospital

Paris, 75013, France

Location contact

Anne BACHELOT, MD-PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

Questionnaires about fertility and potential pregnancies

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Anne BACHELOT, MD, PhD

CONTACT

[email protected]

+33 01 42 16 02 46 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Description of Fertility and Pregnancies in Patients With Polycystic Ovary Syndrome

Acronym: FERTIOPK

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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