Cryopreservation of Ovarian Cortex in Girls With Turner Syndrome

NCT01410045 | Active Not Recruiting

• 1 other identifier: P081204
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Ovarian insufficiency is common in Turner syndrome related to premature and rapid follicular apoptosis and spontaneous pregnancies are rare in this population. Ovarian cryopreservation has been used in an effort to preserve fertility in patients undergoing treatments which lead to premature and severe ovarian insufficiency. This study aims to assess the relevance of ovarian tissue cryopreservation in girls with Turner syndrome. Based on ovarian follicular density as primary outcome and karyotypic, clinical and hormonal markers as secondary outcomes, analysis of the study will allow to select the patients to whom the procedure would benefit the most.

Conditions

Turner Syndrome; Ovarian Insufficiency

Keywords

Turner syndrome; infertility; ovarian insufficiency; ovarian cryopreservation

Outcome Measures

Primary Outcomes (1)

• the ovarian follicular density

  the specific measure is the ovarian follicular density which will allow to Identify criteria, to predict existence or absence of ovarian follicles at the time of the surgery

  at the time of the ovariectomy

Secondary Outcomes (1)

• measure hormonal markers

  Before the ovariectomy, 1 month and 12 months after the ovariectomy

Study Arms (1)

Surgery

EXPERIMENTAL

Ovariectomy

Procedure: Ovariectomy

Interventions

Ovariectomy PROCEDURE

Ovarian cryopreservation has been used in an effort to preserve fertility in patients undergoing treatments which lead to premature and severe ovarian insufficiency.

Surgery

Eligibility Criteria

• Age: 1 Year - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• girls aged from 1 to 25 years included,
• with Turner syndrome or mosaic
• patients aged more than 18 will only have ovarian insufficiency dated less than 5 years
• without any severe disease, particularly of cardiovascular type
• whose agreement to participate to the study has been signed by the parents
• whose agreement to participate to the study has been signed by majority age patient

You may not qualify if:

• girls aged less than one year and over 25 years old
• if any surgery would be contra-indicated
• ovary alone presence
• Well-known infection by HIV, and/or HBV, and/or HCV and/or syphilis TPHA VDRL
• No social coverage affiliate

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead
• Groupe Hospitalier Pitie-Salpetriere: collaborator

Study Sites (1)

Hopital Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

MeSH Terms

Conditions

Turner Syndrome; Infertility

Interventions

Ovariectomy

Condition Hierarchy (Ancestors)

Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sex Chromosome Disorders; Chromosome Disorders; Genetic Diseases, Inborn; Gonadal Disorders; Endocrine System Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Castration; Endocrine Surgical Procedures; Surgical Procedures, Operative; Urogenital Surgical Procedures; Gynecologic Surgical Procedures

Study Officials

• Lise Duranteau, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: August 4, 2011
• Study Start: January 1, 2011
• Primary Completion: January 16, 2014
• Study Completion (Estimated): February 1, 2031
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)