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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborators:
Groupe Hospitalier Pitie-Salpetriere
Cochin Hospital
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01410045
First received: June 28, 2011
Last updated: August 2, 2013
Last verified: July 2013
  Purpose

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 Intervention
Turner Syndrome
Ovarian Insufficiency
Procedure: Ovariectomy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cryopreservation of Ovarian Cortex in Girls With Turner Syndrome : Karyotypic, Clinical and Hormonal Criteria to Screen Patients

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • the ovarian follicular density [ Time Frame: at the time of the ovariectomy ] [ Designated as safety issue: No ]
    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 [ Time Frame: Before the ovariectomy, 1 month and 12 months after the ovariectomy ] [ Designated as safety issue: No ]
    measure hormonal markers as FSH, AMH, Inhibine B and estradiol before, at one month and one year after the ovariectomy


Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Ovariectomy

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

Ages Eligible for Study:   1 Year to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410045

Contacts
Contact: Lise Duranteau, MD, PhD 0033145217842 lise.duranteau@bct.aphp.fr
Contact: Laurence Lecomte, PhD +33 1 71 19 64 94 laurence.lecomte@nck.aphp.fr

Locations
France
Hopital Bicetre Recruiting
Kremlin-Bicetre, France, 94275
Principal Investigator: Lise Duranteau, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Groupe Hospitalier Pitie-Salpetriere
Cochin Hospital
Investigators
Principal Investigator: Lise Duranteau, MD, PhD AP-HP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01410045     History of Changes
Other Study ID Numbers: P081204
Study First Received: June 28, 2011
Last Updated: August 2, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Turner syndrome
infertility
ovarian insufficiency
ovarian cryopreservation

Additional relevant MeSH terms:
Menopause, Premature
Primary Ovarian Insufficiency
Turner Syndrome
Gonadal Dysgenesis
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on August 19, 2014