The Danish TURNER Cryopreservation Study

NCT05740579 | Recruiting

• 1 other identifier: DANTEcryo
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertility Disorders; Turner Syndrome; Premature Ovarian Failure

Outcome Measures

Primary Outcomes (3)

• Number of pregnancies in Turner syndrome women

  The number of pregnancies

  20 to 30 years after cryopreservation

• Number of miscarriages in pregnant Turner syndrome women

  The number of miscarriages

  20 to 30 years after cryopreservation

• Number of liveborn children birthed by Turner syndrome women

  The number of liveborn children

  20 to 30 years after cryopreservation

Secondary Outcomes (20)

• Number of ovarian follicles.

  2-5 days after surgery

• To evaluate predictors of premature ovarian failure in Turner syndrome under 18 years after ovarian cryopreservation.

  From the date of inclusion in study until autotransplantation. Timeframe can be up to 30 years

• To evaluate predictors of premature ovarian failure in Turner syndrome under 18 years after ovarian cryopreservation.

  From the date of inclusion in study until autotransplantation. Timeframe can be up to 30 years

• To evaluate predictors of premature ovarian failure in Turner syndrome under 18 years after ovarian cryopreservation.

  From the date of inclusion in study until autotransplantation. Timeframe can be up to 30 years

• To evaluate predictors of premature ovarian failure in Turner syndrome under 18 years after ovarian cryopreservation.

  From the date of inclusion in study until autotransplantation. Timeframe can be up to 30 years

Interventions

laparoscopic cryopreservation of one ovary PROCEDURE

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.

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ,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.

You may not qualify if:

• Severe cardiac disease which inhibits safe surgery and pregnancy.
• Karyotype with Y chromosome material
• Mental retardation

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Mette Viuff

Aarhus, 8230, Denmark

RECRUITING

MeSH Terms

Conditions

Turner Syndrome; Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sex Chromosome Disorders; Chromosome Disorders; Genetic Diseases, Inborn; Gonadal Disorders; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Diseases

Central Study Contacts

Mette H Viuff, MD PhD

CONTACT

+45 23705085; metteviuff@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: February 23, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): January 1, 2051
• Study Completion (Estimated): January 1, 2051
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)