Fertility and Polycystic Ovary Syndrome
ConditionPolycystic Ovary Syndrome (PCOS)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
PCOS patients and healthy PCOS-free participants previously enrolled in METABOPK research at Pitié-Salpêtrière hospital
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Questionnaires
Other interventionQuestionnaires about fertility and potential pregnancies
Treatment groups
473 Participants
are divided into 2 treatment groupsGroup A: PCOS patients1 intervention
Group B: Control1 intervention
Trial outcomes
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.
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Description of the treatment protocols for infertility
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
Time frame
Through study completion, an average of 1 year2
Description of obstetric complications
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.
Time frame
Through study completion, an average of 1 year3
Identification of hormonal and metabolic factors associated with infertility and obstetric complications
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
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: