Status:
ACTIVE_NOT_RECRUITING
Preservation of Ovarian Cortex Tissue in Girls With Turner Syndrome
Lead Sponsor:
Radboud University Medical Center
Conditions:
Fertility Preservation
Ovarian Tissue Cryopreservation
Eligibility:
FEMALE
2-18 years
Phase:
NA
Brief Summary
Rationale: Infertility due is a major concern for girls with Turner syndrome (TS) and their parents. Physicians are often asked about possible options to preserve their fertility. However, despite som...
Detailed Description
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The primary objective remains to preserve the fertility of the respective (minor) patient, faci...
Eligibility Criteria
Inclusion
- Inclusion criteria
- In order to be eligible to participate in this study, a subject must meet all of the following 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 work up 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:
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Contra-indications for laparoscopic unilateral oophorectomy under general anaesthesia (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 Cincinnati Turner Guideline consensus 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 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. See: References.
Exclusion
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2071
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT03381300
Start Date
January 1 2018
End Date
November 1 2071
Last Update
February 17 2025
Active Locations (1)
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1
Radboud university medical center. Department Obstetrics & Gynaecology.
Nijmegen, Gelderland, Netherlands, 6500HB