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TurnerFertility trial
- Source :
- BMJ Open, 9, 12, pp. e030855, BMJ Open, BMJ Open, 9, e030855, BMJ Open, 9(12):030855, 1-7. BMJ Publishing Group
- Publication Year :
- 2019
- Publisher :
- BMJ Publishing Group, 2019.
-
Abstract
- ObjectiveTo investigate the occurrence of live birth in women with Turner syndrome (TS) after ovarian tissue cryopreservation in childhood followed by auto transplantation in adulthood and to find reliable prognostic markers for estimating the ovarian reserve in girls with TS in the future.SettingAn observational cohort study with long-term follow-up in a tertiary fertility clinic in the Netherlands. Patients recruitment between January 2018 and December 2021.Participants100 females aged 2 through 18 years with classical Turner (ie, 45,X0) or Turner variants (ie, 45,X mosaicism or structural anomalies). Girls with Y chromosomal content, minor X deletions with marginal impact on fertility, active HIV, hepatitis B or hepatitis C infection, and/or an absolute contra indication for surgery, anaesthesia or future pregnancy will be excluded.InterventionsOvarian cortical tissue will be harvested by performing a unilateral oophorectomy via laparoscopic approach. Ovarian cortex fragments will be prepared and cryopreserved. One fragment per patient will be used to determine follicular density by conventional histology, and to perform fluorescence in situ hybridisation analysis of ovarian cells. Routine chromosome analysis will be performed on both lymphocytes and buccal cells. A blood sample will be taken for hormonal analysis and all subjects will undergo a transabdominal ultrasound to determine the uterine and ovarian size. Patient characteristics, pregnancy rates and pregnancy outcomes will be collected from the patient’s medical record.Ethics and disseminationThe study protocol has been approved by the Central Committee on Research Involving Human Subjects in November 2017 (CCMO NL57738.000.16).Trial registration numberNCT03381300.
- Subjects :
- Time Factors
Turner Syndrome
ADOLESCENT
ovarian reserve
Cohort Studies
0302 clinical medicine
Obstetrics and Gynaecology
Turner syndrome
YOUNG-ADULTS
Protocol
Ovarian tissue cryopreservation
030212 general & internal medicine
Fertility preservation
NETWORK
Child
OUTCOMES
TRANSPLANTATIONS
Obstetrics
Vascular damage Radboud Institute for Molecular Life Sciences [Radboudumc 16]
WOMEN
General Medicine
CANCER
Women's cancers Radboud Institute for Health Sciences [Radboudumc 17]
Observational Studies as Topic
Treatment Outcome
PREGNANCY
Research Design
Child, Preschool
Female
CLINICAL-PRACTICE GUIDELINES
Cohort study
medicine.medical_specialty
Ovarian Cortex
fertility preservation
live birth
Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18]
03 medical and health sciences
medicine
Humans
Ovarian reserve
Cryopreservation
Pregnancy
business.industry
Ovary
medicine.disease
ONCOLOGY
Transplantation
business
030217 neurology & neurosurgery
Follow-Up Studies
Subjects
Details
- Language :
- English
- ISSN :
- 20446055
- Volume :
- 9
- Issue :
- 12
- Database :
- OpenAIRE
- Journal :
- BMJ Open
- Accession number :
- edsair.doi.dedup.....a1e0ac2c8244172333b1ea03a788cd33