Menu
Not yet recruiting NCT07499518

Fertility and Polycystic Ovary Syndrome

Observational Polycystic Ovary Syndrome (PCOS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaires.
Who it may be relevant to
Registry conditions: Polycystic Ovary Syndrome (PCOS). Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Description of Fertility and Pregnancies in Patients With Polycystic Ovary Syndrome

Overview

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

  • Other Questionnaires
    Questionnaires about fertility and potential pregnancies

Primary outcome measures

  • Description of the mode of conception [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (3)
  • Description of the treatment protocols for infertility [Time frame: Through study completion, an average of 1 year]
  • Description of obstetric complications [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

France · 1 center
  • Endocrinology department, Pitié Salpêtrière hospital — Paris

Identifiers

NCT: NCT07499518 · APHP260113

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗