Preservation of ovarian cortex tissue in girls with Turner syndrome: A multicenter exploratory intervention study

Recruiting

• Conditions: Turner syndrome; 10014701; 10083624; 10010612

• Registration Number: NL-OMON47177
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

• Girls and young females with classic Turner (i.e. 45X monosomy) or Turner variants (e.g. 45X/46XX mosaicism, ring X mosaicism, isochromosome X),
• Aged 2 through 18 years,
• who completed the diagnostic workup phase of TS including routine cardiac screening*,
• whose agreement to participate in this study has been signed by the parents (girls 2-11 years old),
• whose agreement to participate in this study has been signed by the patient and her parents (girls 12-17 years old),
• whose agreement to participate in this study has been signed by the patient (adolescents of 18 years old).

Exclusion Criteria

• Contra-indications for laparoscopic unilateral oophorectomy under general anaesthia (e.g. severe cardiovascular comorbidity and/or BMI >40 kg/m2)*,
• Contra-indications for cryopreservation (i.e. active HIV, hepatitis-B or hepatitis-C infection);*Based on the international Cincinatti Turner Guideline Concensus Meeting, July 2016 and consultation of Dutch cardiologists, paediatric-cardiologists and anaesthesists between 2016-2017 there are no absolute cardiovascular contra-indications for surgical intervention and/or pregnancy. Advice against surgical intervention and/or pregnancy should be based on the patient-specific cardiovascular risk profile. The 2% mortality risk due to acute aortic dissection is based on one survey and literature review study (Karnis et al. 2003) that reported the outcomes of 101 pregnancies in patients with TS after oocyte donation. Only 50% of the patients were screened by a cardiologist before entering the oocyte donation programme. Therefore, all girls who want to participate in this study should have completed the diagnostic work up phase of TS including routine cardiac screening and will be screened by a paediatric anaesthesist. Exclusion will be based on the patient specific risk profile.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Live birth after auto transplantation of cryopreserved-thawed ovarian cortical<br /><br>tissue (i.e. live birth rate or LBR)<br /><br><br /><br>proximate: The number of primordial follicles found in the ovarian tissue</p><br>