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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCOS patients | PCOS patients aged between 18 and 45 years |
| |
| Control | Control (PCOS free) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other | Questionnaires about fertility and potential pregnancies |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion, an average of 1 year |
| Description of obstetric complications |
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Inclusion Criteria- PCOS group:
Inclusion Criteria- Control group
Exclusion Criteria:
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PCOS patients and healthy PCOS-free participants previously enrolled in METABOPK research at Pitié-Salpêtrière hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne BACHELOT, MD, PhD | Contact | +33 01 42 16 02 46 | +33 | anne.bachelot@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Anne BACHELOT, MD-PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endocrinology department, Pitié Salpêtrière hospital | Paris | 75013 | France |
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.
Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Researchers who provide a methodologically sound proposal
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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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. |
| Through study completion, an average of 1 year |
| 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 | Through study completion, an average of 1 year |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |