Cryopreservation of Ovarian Cortex in Girls With Turner Syndrome
|Brief Title †||Cryopreservation of Ovarian Cortex in Girls With Turner Syndrome|
|Official Title †||Cryopreservation of Ovarian Cortex in Girls With Turner Syndrome : Karyotypic, Clinical and Hormonal Criteria to Screen Patients|
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.
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|
|Study Design †||Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention|
|Primary Outcome Measure †||the ovarian follicular density|
|Secondary Outcome Measure †||measure hormonal markers|
|Study Arms / Comparison Groups||
|* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.|
|Recruitment Status †||Procedure|
|Estimated Enrollment †||50|
|Start Date †||January 2011|
|Completion Date||September 2014|
|Primary Completion Date||February 2014|
|Eligibility Criteria †||
Inclusion criteria :
|Ages||1 Year - 25 Years|
|Accepts Healthy Volunteers||No|
|Location Countries †||France,|
|NCT ID †||NCT01410045|
|Secondary IDs ††|
|Study Sponsor †||Assistance Publique - Hôpitaux de Paris|
|Investigators †||Principal Investigator: Lise Duranteau, MD, PhD, AP-HP|
|Information Provided By||Assistance Publique - Hôpitaux de Paris|
|Verification Date||July 2013|
|First Received Date †||June 28, 2011|
|Last Updated Date||August 2, 2013|
†† WHO trial registration data element that is required only if it exists.