Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 19 of 566 for:    "Polycystic Ovary Syndrome"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03483792
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief 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. 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.


Condition or disease Intervention/treatment
Polycystic Ovary Syndrome Biological: Plasma dosage Genetic: placental biopsy

Layout table for study information
Study Type : Observational
Estimated Enrollment : 58 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Heritability of Polycystic Ovary Syndrome: Role of Antimullerian Hormone, Steroids and Leptin
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
PCOS group Biological: Plasma dosage
4 x 7 ml of blood punction at each control visit of the three trimesters of pregnancy

Genetic: placental biopsy
Immediately following delivery (<12h postpartum), placental biopsies (Collection of 4 placental fragments)

Control group Biological: Plasma dosage
4 x 7 ml of blood punction at each control visit of the three trimesters of pregnancy

Genetic: placental biopsy
Immediately following delivery (<12h postpartum), placental biopsies (Collection of 4 placental fragments)




Primary Outcome Measures :
  1. Rate of plasma AMH in the 3rd trimester of pregnancy [ Time Frame: between 29 and 44 amenorrhea weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. The rate of leptin (only dosage in fasting patients) [ Time Frame: between 5 and 15 amenorrhea weeks ]
  5. The level of expression of aromatase, AMH and AMH Receptor II in the placenta [ Time Frame: at delivery ]

Biospecimen Retention:   Samples With DNA
plasma placenta fragment


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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)
Criteria

Inclusion Criteria:

  • 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
    • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483792


Contacts
Layout table for location contacts
Contact: Sophie Catteau-Jonard, MD,PhD 3 20 44 63 09 ext +33 sophie.jonard@chru-lille.fr

Locations
Layout table for location information
France
Hôpital Jeanne de Flandres, CHU Recruiting
Lille, France
Principal Investigator: sophie Jonard, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Layout table for investigator information
Principal Investigator: Sophie Catteau-Jonard, MD,PhD University Hospital, Lille

Layout table for additonal information
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03483792     History of Changes
Other Study ID Numbers: 2017_11
2017-A02628-45 ( Other Identifier: ID-RCB number, ANSM )
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
PCOS
AMH
Pregnancy
Heritability
LH

Additional relevant MeSH terms:
Layout table for MeSH terms
Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs