NCT00780897

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

October 28, 2008

Status Verified

October 1, 2008

Enrollment Period

4 years

First QC Date

October 27, 2008

Last Update Submit

October 27, 2008

Conditions

Keywords

PREMATURE OVARIAN FAILURE (POF)GENETIC ANALYSISPHYSIOPATHOLOGIC ANALYSIS

Study Arms (2)

1

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;

2

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

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

POF patients \& controls

You may qualify if:

  • Experimental group:
  • 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:
  • years \<Age\> 39 years
  • Patient having a benign ovarian pathology justifying an ovarian surgery
  • Informed Consent Form Signature

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hopitalier Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

One ovarian biopsy during the protocol to evaluate ovocytes number and transcriptome analysis.

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Philippe Touraine, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Touraine, MD, PhD

CONTACT

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2008

First Posted

October 28, 2008

Study Start

March 1, 2005

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

October 28, 2008

Record last verified: 2008-10

Locations