Cryopreservation of Ovarian Cortex in Girls With Turner Syndrome

Turner Syndrome Clinical Trial

— CRYO-X0  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01410045
• Other study ID #: P081204
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2011
• Est. completion date: February 2031

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 47
• Est. completion date: February 2031
• Est. primary completion date: January 16, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 1 Year to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Ovarian Insufficiency
• Syndrome
• Turner Syndrome

Intervention

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.

Locations

Country	Name	City	State
France	Hopital Bicêtre	Le Kremlin-Bicêtre

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	measure hormonal markers	measure hormonal markers as FSH, AMH, Inhibine B and estradiol before, at one month and one year after the ovariectomy	Before the ovariectomy, 1 month and 12 months after the ovariectomy