Clinical trial NCT01410045: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Turner Syndrome
Ovarian Insufficiency
Keywords: Turner syndrome
infertility
ovarian insufficiency
ovarian cryopreservation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Groupe Hospitalier Pitie-Salpetriere
First posted: 2011-08-04
Enrollment: 47
Sex: FEMALE
Minimum age (years): 1
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the ovarian follicular density
timeFrame: at the time of the ovariectomy
Secondary outcomes:
measure: measure hormonal markers
timeFrame: Before the ovariectomy, 1 month and 12 months after the ovariectomy
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Hopital Bicêtre
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Lise Duranteau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: