Cryopreservation of Ovarian Cortex in Girls With Turner Syndrome (CRYO-X0)
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|ClinicalTrials.gov Identifier: NCT01410045|
Recruitment Status : Active, not recruiting
First Posted : August 4, 2011
Last Update Posted : March 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Turner Syndrome Ovarian Insufficiency||Procedure: Ovariectomy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cryopreservation of Ovarian Cortex in Girls With Turner Syndrome : Karyotypic, Clinical and Hormonal Criteria to Screen Patients|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||January 16, 2014|
|Estimated Study Completion Date :||February 2031|
Ovarian cryopreservation has been used in an effort to preserve fertility in patients undergoing treatments which lead to premature and severe ovarian insufficiency.
- the ovarian follicular density [ Time Frame: 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
- measure hormonal markers [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410045
|Kremlin-Bicetre, France, 94275|
|Principal Investigator:||Lise Duranteau, MD, PhD||Assistance Publique - Hôpitaux de Paris|