Polycystic Ovary SyndromeHERITOPKNCT03483792
Heritability of Polycystic Ovary Syndrome: Role of Antimullerian Hormone, Steroids and Leptin
An observational study of Polycystic Ovary Syndrome, run by University Hospital, Lille at 1 site in France.
Trial summary
Polycystic ovary syndrome (PCOS) is the most common cause of ovulation disorders and affects 10 to 15% of women. Despite its frequency, its physiopathology remains unknown. In women, Anti-Müllerian hormone (AMH) is secreted by granulosa cells located in the ovaries within the follicles. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Plasma dosage and placental biopsy
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 20 Apr 2018to 2 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 43 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients having a pre-conceptionnal infertility assessment in the gynecology-Endocrinology department of the CHRU of Lille, in the first trimester of monofetal pregnancy (between 5 and 10 weeks of gestation), obtained spontaneously, after induction of ovulation or Assisted Reproductive Techniques (ART)
Who may be able to join
- Having a pre-conceptional infertility assessment in the gynecology-Endocrinology department of University Hospital of Lille
- in the first trimester of mono fetal pregnancy (between 5 and 10 weeks of gestation), obtained spontaneously, after induction of ovulation or Assisted Reproductive Techniques (ART)
- Pregnancy followed at University Hospital of Lille
- PCOS group: defined according to modified Rotterdam criteria (2003 and 2011)
- At least 2 of the following 3 criterion:
- Cycle disorder
Show all 11Show fewer
- Clinical and / or biological hyperandrogenism
- Ovarian volume > 10cm³ and/or more than 19 follicles from 2 to 9 mm per ovary
- After exclusion of other causes of cycle disorder or hyperandrogenism
- Control group: patient with severe male and / or tubal infertility, no cycling disorder, normal ovarian reserve (FSH<10 IU / L, E2<50 pg / ml, AMH>7 and <35 pmol / L and Follicles count between >5 and <20 per ovary at day 3 of the cycle).
- In the group of female controls, the fertility problem is not related to a female pathology of the hypothalamic-pituitary-ovarian axis (tubal or male infertility). They are women without ovarian personal pathology. The problem of fertility being of other origin.
Who cannot join
- Multiple pregnancy
- Pregnancy after egg donation
- Long-term drug therapy (excluding routine pregnancy supplementation)
- Previous Diabetes
- Bariatric surgery
- Patients with ovulatory infertility of central or idiopathic origin
- Patients already included in another protocol
Trial locations and contacts
1 site in 1 country.
About this study
Polycystic ovary syndrome (PCOS) is the most common cause of ovulation disorders and affects 10 to 15% of women. Despite its frequency, its physiopathology remains unknown.
In women, Anti-Müllerian hormone (AMH) is secreted by granulosa cells located in the ovaries within the follicles. Compared to control women, serum AMH level is higher in PCOS women and could play a role in its pathophysiology. The severity of the PCOS phenotype is correlated with the production of AMH.
Read more
It is currently described in the literature that daughters of women with PCOS have a 50% risk of developing PCOS, but no genetic cause of transmission is known. In mice (article in press), pregnant females injected with AMH give birth to offspring with PCOS symptoms. The AMH could thus also play a role in the heritability of PCOS in women. Our team demonstrated that AMH, in its active cleaved form, had a direct central action on the hypothalamus by increasing the pulsatility of GnRH, inducing LH hypersecretion. The hypothesis is that AMH remains higher in pregnant women with PCOS and may affect the fetus by altering fetal and maternal hypothalamic secretions or by modifying placental steroid production.
Leptin has a role in reproduction, through its receptors located at the central (hypothalamus) and peripheral (granulosa cells) levels. In excessively high serum concentration, as observed in obesity, it would lead to a dysregulation of GnRH secretion, an alteration of ovarian steroidogenesis and a dysregulation of folliculogenesis.
Will be compare leptin levels in first trimester patients with and without PCOS to look for possible correlations between AMH and leptin and eliminate possible bias.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Plasma dosage, placental biopsy
- Keywords
- PCOS, AMH, Pregnancy, Heritability, LH
- 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.
Plasma dosageBiological
4 x 7 ml of blood punction at each control visit of the three trimesters of pregnancy
placental biopsyGenetic
Immediately following delivery (<12h postpartum), placental biopsies (Collection of 4 placental fragments)
| Study group | Role | What they receive |
|---|---|---|
| PCOS group | Not described Receives: Biological: Plasma dosage; Genetic: placental biopsy | |
| Control group | Not described Receives: Biological: Plasma dosage; Genetic: placental biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of plasma AMH in the 3rd trimester of pregnancy
Measured: between 29 and 44 amenorrhea weeks
Secondary outcomes (5)
The variation of maternal plasma AMH
Measured: At baseline, between 5 and 15 amenorrhea weeks, between 15+1 day and 28+ 6 days amenorrhea weeks, between 29 and 44 amenorrhea weeks
The percentage change in the different forms of AMH (pro-AMH and cleaved forms)
Measured: At baseline, between 5 and 15 amenorrhea weeks, between 15+1 day and 28+ 6 days amenorrhea weeks, between 29 and 44 amenorrhea weeks
The variation in oestradiol, testosterone and LH levels
Measured: At baseline, between 5 and 15 amenorrhea weeks, between 15+1 day and 28+ 6 days amenorrhea weeks, between 29 and 44 amenorrhea weeks
The rate of leptin (only dosage in fasting patients)
Measured: between 5 and 15 amenorrhea weeks
The level of expression of aromatase, AMH and AMH Receptor II in the placenta
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start20 Apr 2018
- Primary completion2 Jun 2022
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Catteau-Jonard, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483792
- Sponsor's protocol ID
- 2017_11
- Other IDs
- 2017-A02628-45
- Acronym
- HERITOPK
- Status last verified
- Dec 2025
- First submitted
- 14 Feb 2018
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Peigne M, Simon V, Pigny P, Mimouni NEH, Martin C, Dewailly D, Catteau-Jonard S, Giacobini P. Changes in circulating forms of anti-Muullerian hormone and androgens in women with and without PCOS: a systematic longitudinal study throughout pregnancy. Hum Reprod. 2023 May 2;38(5):938-950. doi: 10.1093/humrep/dead050.
PubMed 36921289
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heritability of Polycystic Ovary Syndrome: Role of Antimullerian Hormone, Steroids and Leptin
- ClinicalTrials.gov ID
- NCT03483792
- Acronym / sponsor ID
- HERITOPK / 2017_11
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, AMH, Pregnancy, Heritability, LH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 30 Mar 2018 (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 cause of ovulation disorders and affects 10 to 15% of women. Despite its frequency, its physiopathology remains unknown.
In women, Anti-Müllerian hormone (AMH) is secreted by granulosa cells located in the ovaries within the follicles. Compared to control women, serum AMH level is higher in PCOS women and could play a role in its pathophysiology. The severity of the PCOS phenotype is correlated with the production of AMH.
It is currently described in the literature that daughters of women with PCOS have a 50% risk of developing PCOS, but no genetic cause of transmission is known. In mice (article in press), pregnant females injected with AMH give birth to offspring with PCOS symptoms. The AMH could thus also play a role in the heritability of PCOS in women. Our team demonstrated that AMH, in its active cleaved form, had a direct central action on the hypothalamus by increasing the pulsatility of GnRH, inducing LH hypersecretion. The hypothesis is that AMH remains higher in pregnant women with PCOS and may affect the fetus by altering fetal and maternal hypothalamic secretions or by modifying placental steroid production.
Leptin has a role in reproduction, through its receptors located at the central (hypothalamus) and peripheral (granulosa cells) levels. In excessively high serum concentration, as observed in obesity, it would lead to a dysregulation of GnRH secretion, an alteration of ovarian steroidogenesis and a dysregulation of folliculogenesis.
Will be compare leptin levels in first trimester patients with and without PCOS to look for possible correlations between AMH and leptin and eliminate possible bias.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS group | – | Biological: Plasma dosage, Genetic: placental biopsy |
| Control group | – | Biological: Plasma dosage, Genetic: placental biopsy |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients having a pre-conceptionnal infertility assessment in the gynecology-Endocrinology department of the CHRU of Lille, in the first trimester of monofetal pregnancy (between 5 and 10 weeks of gestation), obtained spontaneously, after induction of ovulation or Assisted Reproductive Techniques (ART)
Key inclusion criteria (11 listed)
- Having a pre-conceptional infertility assessment in the gynecology-Endocrinology department of University Hospital of Lille
- in the first trimester of mono fetal pregnancy (between 5 and 10 weeks of gestation), obtained spontaneously, after induction of ovulation or Assisted Reproductive Techniques (ART)
- Pregnancy followed at University Hospital of Lille
- PCOS group: defined according to modified Rotterdam criteria (2003 and 2011)
- At least 2 of the following 3 criterion:
Key exclusion criteria (7 listed)
- Multiple pregnancy
- Pregnancy after egg donation
- Long-term drug therapy (excluding routine pregnancy supplementation)
- Previous Diabetes
- Bariatric surgery
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 |
|---|---|---|
| Plasma dosage4 x 7 ml of blood punction at each control visit of the three trimesters of pregnancy | Biological | Control group, PCOS group |
| placental biopsyImmediately following delivery (<12h postpartum), placental biopsies (Collection of 4 placental fragments) | Genetic | Control group, PCOS group |
Primary outcome
Rate of plasma AMH in the 3rd trimester of pregnancy
Time frame: between 29 and 44 amenorrhea weeks
5 secondary outcomes
The variation of maternal plasma AMH
Time frame: At baseline, between 5 and 15 amenorrhea weeks, between 15+1 day and 28+ 6 days amenorrhea weeks, between 29 and 44 amenorrhea weeks
The percentage change in the different forms of AMH (pro-AMH and cleaved forms)
Time frame: At baseline, between 5 and 15 amenorrhea weeks, between 15+1 day and 28+ 6 days amenorrhea weeks, between 29 and 44 amenorrhea weeks
The variation in oestradiol, testosterone and LH levels
Time frame: At baseline, between 5 and 15 amenorrhea weeks, between 15+1 day and 28+ 6 days amenorrhea weeks, between 29 and 44 amenorrhea weeks
The rate of leptin (only dosage in fasting patients)
Time frame: between 5 and 15 amenorrhea weeks
The level of expression of aromatase, AMH and AMH Receptor II in the placenta
Time frame: at delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Results publication: PubMed 36921289Peigne M, Simon V, Pigny P, Mimouni NEH, Martin C, Dewailly D, Catteau-Jonard S, Giacobini P. Changes in circulating forms of anti-Muullerian hormone and androgens in women with and without PCOS: a systematic longitudinal study throughout pregnancy. Hum Reprod. 2023 May 2;38(5):938-950. doi: 10.1093/humrep/dead050.
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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. This study is not recruiting at the moment.
Sophie Catteau-Jonard, MD,PhD principal investigator
University Hospital, Lille
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, run by University Hospital, Lille 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 11 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: finished, as of the sponsor's last update on 23 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of plasma AMH in the 3rd trimester of pregnancy (time frame: between 29 and 44 amenorrhea weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03483792, which also lists 1 linked publication.
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 23 Dec 2025.