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Premature Ovarian Failure (Genetic and Physiopathologic Analysis) (GéNIOP)

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ClinicalTrials.gov Identifier: NCT00780897
Recruitment Status : Unknown
Verified October 2008 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : October 28, 2008
Last Update Posted : October 28, 2008
Information provided by:

Study Description
Brief 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.

Condition or disease
Premature Ovarian Failure

Detailed 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.

Study Design

Study Type : Observational
Estimated Enrollment : 87 participants
Time Perspective: Cross-Sectional
Official Title: Premature Ovarian Failure : Genetic and Physiopathologic Analysis
Study Start Date : March 2005
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

POF patients; 18 years <Age> 40 years; Hormonal sampling; FMR1 analysis; FSH Receptor gene analysis; LH Receptor gene analysis; BMP15 gene analysis; GDF9 gene analysis; Connexin 37 analysis; Ovarian biopsy; Bone Mineral Density; Pelvic Ultrasonography;
Control Group No POF patients; Benign ovarian pathology; 18 years <Age> 40 years; Hormonal sampling; FMR1 analyze; FSH Receptor gene analysis; LH Receptor gene analysis; BMP15 gene analysis; GDF9 gene analysis; Connexin 37 analysis; Ovarian biopsy under specific conditions; Bone Mineral Density; Pelvic Ultrasonography

Outcome Measures

Biospecimen Retention:   Samples With DNA
One ovarian biopsy during the protocol to evaluate ovocytes number and transcriptome analysis.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
POF patients & controls

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:

Contacts and Locations

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): NCT00780897

Contact: Philippe Touraine, MD, PhD +33 1 42 16 02 11 philippe.touraine@psl.aphp.fr

Groupe Hopitalier Pitié-Salpêtrière Recruiting
Paris, France, 75013
Contact: Philippe Touraine, MD, PhD    +33 1 42 16 02 11      
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Philippe Touraine, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information

Responsible Party: Myriem Carrier, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00780897     History of Changes
Other Study ID Numbers: P040801
First Posted: October 28, 2008    Key Record Dates
Last Update Posted: October 28, 2008
Last Verified: October 2008

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Additional relevant MeSH terms:
Premature Birth
Primary Ovarian Insufficiency
Menopause, Premature
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases