NCT03483792: HERITOPK

Heritability of Polycystic Ovary Syndrome: Role of Antimullerian Hormone, Steroids and Leptin

Completed Last updated 23 December 2025

What this trial tests

trial testing Plasma dosage in Polycystic Ovary Syndrome in 58 participants. Completed in 2 June 2022.

Timeline

20 April 2018

Primary endpoint
2 June 2022

2 June 2022

Quick facts

Lead sponsor	University Hospital, Lille
Status	Completed
Study type	OBSERVATIONAL
Enrollment	58
Start date	20 April 2018
Primary completion	2 June 2022
Estimated completion	2 June 2022
Sites	1 location across France

Drugs / interventions tested

• Plasma dosage — full drug profile →
• placental biopsy

Conditions studied

• Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →

Sponsor

University Hospital, Lille

Who can join

Adults 18 to 43, female only, with Polycystic Ovary Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Changes in circulating forms of anti-Muüllerian hormone and androgens in women with and without PCOS: a systematic longitudinal study throughout pregnancy.
   Peigné M, Simon V, Pigny P, Mimouni NEH, et al · · 2023 · cited 16× · PMID 36921289 · DOI 10.1093/humrep/dead050