Premature Ovarian Failure (Genetic and Physiopathologic Analysis)

Premature Ovarian Failure Clinical Trial

— GéNIOP  

Official title:

Premature Ovarian Failure : Genetic and Physiopathologic Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00780897
• Other study ID #: P040801
• Status: Recruiting
• Phase: N/A
• First received: October 27, 2008
• Last updated: October 27, 2008
• Start date: March 2005
• Est. completion date: March 2009

Study information

• Verified date: October 2008
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Philippe Touraine, MD, PhD
• Phone: +33 1 42 16 02 11
• Email: philippe.touraine[@]psl.aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Premature Ovarian Failure (POF), syndrome observed in young woman, present consequences on hormonal and leads at definitive infertility. It's a rare and complex syndrome and for this reason, we propose to initiate a collaborative team network to understand better his genetic and physiopathology.

We are going to realize a global study of this syndrome with clinical and fundamentals approaches. We wish that this project allows us to understand better the physiopathology of this rare disease. Finally, POF responsible genes identification is the base for future development of therapeutics approaches.

Description:

Premature ovarian failure (POF) is a rare but not exceptional disease concerning 0.1% of the more-than-thirty-years-old women. On the clinical aspect, patients present a primary or secondary amenorrhea depending on when the disease occurs in their lives. Infertility is most of the time definitive and the yet only available therapy is auto implantation of cryopreserved oocytes. Initiation of a substitutive hormonal treatment is also necessary to prevent the consequences of estrogenic hardship (i.e leading to osteoporosis).

POF has numerous possible origins, and can be linked to auto-immune diseases, metabolic disorders (i.e. galactosemia) or even genetic abnormalities. According to her origin, POF is characterized by (a) a depletion of primary follicles, (b) increased or accelerated follicle atresia (c) an alteration of the recruitment of dominant follicle and (d) stopped follicular maturation.

The purpose of our work is to organize a clinical and fundamental research network focussed on premature ovarian failure (POF). It will aim to collect clinical, biological, radiological and histological information on patients, and according to their phenotypes, to decide for searching possible genetic abnormalities leading to POF. And in the same time, the constitution of a broad tissue collection allows the study of ovarian transcripts, using POF as a pathologic model to describe ovaries and follicle development-involved genes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 87
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion criteria :

Experimental group:

• 18 years <Age> 39 years

• Patient with amenorrhea since at least 3 months

• Patient with at least 1 FSH dosage > 30 mUI/L

• Patients between 40 and 45 years old with hormonal results indicating a POF declared before 39 years old will be included.

• Informed Consent Form Signature

Control group:

• 18 years <Age> 39 years

• Patient having a benign ovarian pathology justifying an ovarian surgery

• Informed Consent Form Signature

Exclusion criteria:

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Locations

Country	Name	City	State
France	Groupe Hopitalier Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France,