Polycystic Ovary Syndrome (PCOS)FERTIOPKNCT07499518
Fertility and Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome (PCOS), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS)
- What is being tested?
- Questionnaires
- How many people
- 473 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2026to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: PCOS patients and healthy PCOS-free participants previously enrolled in METABOPK research at Pitié-Salpêtrière hospital
Who may be able to join
- 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
- Female with normal metabolic and hormonal profiles
- Previouslu enrolled in METABOPK research
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Endocrinology department, Pitié Salpêtrière hospital
Paris, 75013
Anne BACHELOT, MD-PhD, anne.bachelot@aphp.fr
About this study
Official title: Description of Fertility and Pregnancies in Patients With 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:
- Oligo-anovulation
- Clinical and/or biological hyperandrogenism
- 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.
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Being tested
- Questionnaires
- Keywords
- PCOS, Fertility, parental project, pregnancy, hormonal factors, metabolic factors
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Questionnaires about fertility and potential pregnancies
| Study group | Role | What they receive |
|---|---|---|
| PCOS patients | PCOS patients aged between 18 and 45 years Receives: Other: Questionnaires | |
| Control | Control (PCOS free) Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
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
Measured: Through study completion, an average of 1 year
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.
Measured: 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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 473 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne BACHELOT, MD-PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499518
- Sponsor's protocol ID
- APHP260113
- Acronym
- FERTIOPK
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of Fertility and Pregnancies in Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07499518
- Acronym / sponsor ID
- FERTIOPK / APHP260113
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Keywords
- PCOS, Fertility, parental project, pregnancy, hormonal factors, metabolic factors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 473 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Oligo-anovulation
- Clinical and/or biological hyperandrogenism
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS patients | – | Other: QuestionnairesPCOS patients aged between 18 and 45 years |
| Control | – | Other: QuestionnairesControl (PCOS free) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- PCOS patients and healthy PCOS-free participants previously enrolled in METABOPK research at Pitié-Salpêtrière hospital
Key inclusion criteria (6 listed)
- 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
- Female with normal metabolic and hormonal profiles
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuestionnaires about fertility and potential pregnancies | Other | Control, PCOS patients |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne BACHELOT, MD-PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome (PCOS), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne BACHELOT, MD, PhD (+33 01 42 16 02 46 ext. +33, anne.bachelot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the mode of conception (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.