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Recruiting NCT05740579

NCT05740579 The Danish TURNER Cryopreservation Study

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Clinical Trial Summary
NCT ID NCT05740579
Status Recruiting
Phase
Sponsor University of Aarhus
Condition Fertility Disorders
Study Type INTERVENTIONAL
Enrollment 100 participants
Start Date 2023-01-01
Primary Completion 2051-01-01

Eligibility & Interventions

Sex Female only
Min Age 2 Years
Max Age 17 Years
Study Type INTERVENTIONAL
Interventions
laparoscopic cryopreservation of one ovary

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 100 participants in total. It began in 2023-01-01 with a primary completion date of 2051-01-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 Criteria

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

Contact & Investigator

Central Contact

Mette H Viuff, MD PhD

✉ metteviuff@clin.au.dk

📞 +45 23705085

Frequently Asked Questions

Who can join the NCT05740579 clinical trial?

This trial is open to female participants only, aged 2 Years or older, up to 17 Years, studying Fertility Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05740579 currently recruiting?

Yes, NCT05740579 is actively recruiting participants. Contact the research team at metteviuff@clin.au.dk for enrollment information.

Where is the NCT05740579 trial being conducted?

This trial is being conducted at Aarhus, Denmark.

Who is sponsoring the NCT05740579 clinical trial?

NCT05740579 is sponsored by University of Aarhus. The trial plans to enroll 100 participants.

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