CRYO-X0: Cryopreservation of Ovarian Cortex in Girls With Turner Syndrome

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01410045

Collaborator

Groupe Hospitalier Pitie-Salpetriere (Other)

Enrollment

Location

Arm

241

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Turner Syndrome Ovarian Insufficiency	Procedure: Ovariectomy	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Cryopreservation of Ovarian Cortex in Girls With Turner Syndrome : Karyotypic, Clinical and Hormonal Criteria to Screen Patients

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Jan 16, 2014

Anticipated Study Completion Date :

Feb 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Surgery Ovariectomy	Procedure: Ovariectomy Ovarian cryopreservation has been used in an effort to preserve fertility in patients undergoing treatments which lead to premature and severe ovarian insufficiency.

Arm

Intervention/Treatment

Experimental: Surgery

Ovariectomy

Procedure: Ovariectomy

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

Outcome Measures

Primary Outcome Measures

the ovarian follicular density [at the time of the ovariectomy]
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

Secondary Outcome Measures

measure hormonal markers [Before the ovariectomy, 1 month and 12 months after the ovariectomy]
measure hormonal markers as FSH, AMH, Inhibine B and estradiol before, at one month and one year after the ovariectomy

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 25 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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