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Clinical Trials in Denmark / NCT05740579
Recruiting Not applicable

The Danish TURNER Cryopreservation Study

NCT05740579 · tracked via the Priya Life Science Denmark tracker
Sponsor
University of Aarhus
Phase
Not applicable
Started
2023-01-01
Last updated
2024-05-24

Condition(s) studied

Fertility DisordersTurner SyndromePremature Ovarian Failure

Investigational drug(s) / intervention(s)

laparoscopic cryopreservation of one ovary

laparoscopic cryopreservation of one ovary: Laparoscopic removal of one ovary as child. In adulthood cortical tissue is replaced in the abdomen in order to improve fertility and pregnancy rates in Turner syndrome women.

Study summary

The goal of this clinical trial is to investigate if cryopreservation of ovarian tissue in girls with Turner syndrome can improve their fertility and lead to increased number of liveborn babies of Turner syndrome mothers. Women with Turner syndrome suffer from premature ovarian insufficiency which leads to infertility and lack of estrogen.

The main questions it aims to answer are:

* Does the number of pregnancies and liveborn children increase after cryopreservation of ovarian tissue in turner syndrome?
* Is the possible to predict when a girl with Turner syndrome reach menopause using monitoring of sex hormones?
* Is it possible to identify any genes causing ovarian failure in Turner syndrome females?

Participants between 2-18 years old will be asked to participate in a laparoscopic surgery and removal of one ovary in order to cryopreserve the tissue until adulthood. The the cortical tissue will be autotransplanted in order to preserve fertility. The participant will during the study period be monitored using sex hormones.

Furthermore, the investigators wish to investigate the ovarian tissue using RNA sequencing and DNA methylation analysis.

No comparison group is present.

Eligibility

Sex
FEMALE
Min age
2 Years
Max age
17 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 45,X karyotype or other Turner variant karyotypes (45,X/46,XX mosaicism, ring X mosaicism, isochromosome X) * Age 2-17 years old * Ability to participate in a physical examination including a cardiac examination. * Signed consent from both parents. Exclusion Criteria: * Severe cardiac disease which inhibits safe surgery and pregnancy. * Karyotype with Y chromosome material * Mental retardation

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Mette Viuff Aarhus Denmark Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05740579 on ClinicalTrials.gov ↗ ← All trials in Denmark