Overview

This trial is active, not recruiting.

Conditions turner syndrome, ovarian insufficiency
Treatment ovariectomy
Sponsor Assistance Publique - Hôpitaux de Paris
Collaborator Groupe Hospitalier Pitie-Salpetriere
Start date January 2011
End date July 2016
Trial size 47 participants
Trial identifier NCT01410045, P081204

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Ovariectomy
ovariectomy
Ovarian cryopreservation has been used in an effort to preserve fertility in patients undergoing treatments which lead to premature and severe ovarian insufficiency.

Primary Outcomes

Measure
the ovarian follicular density
time frame: at the time of the ovariectomy

Secondary Outcomes

Measure
measure hormonal markers
time frame: Before the ovariectomy, 1 month and 12 months after the ovariectomy

Eligibility Criteria

Female participants from 1 year up to 25 years old.

Inclusion criteria : - 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 Exclusion criteria : - 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

Additional Information

Official title Cryopreservation of Ovarian Cortex in Girls With Turner Syndrome : Karyotypic, Clinical and Hormonal Criteria to Screen Patients
Principal investigator Lise Duranteau, MD, PhD
Description Turner syndrome (TS) is characterized by the absence of all or part of a normal second X chromosome and occurs in about 1/2,500 live-born girls. Spontaneous fertility is rare among patients with TS related to premature apoptosis of ovarian follicles. Spontaneous puberty and fertility has been reported mostly in patients with mosaic karyotype or small X deletions. There is robust evidence that follicles can be observed in ovaries in girls with TS. However, follicular density and quality seems to be largely influenced by karyotype, ovarian morphology and endocrine competence. There are no clear-cut clinical or hormonal markers to assess the ovarian reserve in girls with TS but markers of ovarian function used in women with premature ovarian insufficiency are measured. In TS, it is now fundamental to be able to evaluate the prognosis of the ovarian function and the degree of fertility to provide the relevant information to girls and their parents and to discuss possibilities of motherhood if any. 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 screen the patients to whom the procedure would benefit the most. Girls who will be operated will accept to come for a follow-up visit at one and 12 months after the surgery. It is expected to have clinical and hormonal information through a long follow up performed by the referred paediatrician. Results of the study will allow us to select patients with TS who will benefit the most of this fertility preservation procedure based on karyotypic, clinical and hormonal profile.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.