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Turner Syndrome Minipuberty Study

NCT04189406 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2023-11-29

No results posted yet for this study

Summary

Rationale: Due to accelerated germ cell loss, infertility is a major problem in girls with Turner syndrome (TS). Therefore, cryopreservation of ovarian tissue or oocytes before exhaustion of the ovarian reserve may preserve fertility in patients with TS. However, in the majority of females with TS , the ovarian reserve is exhausted before the age of menarche. Early markers indicating and predicting the ovarian reserve are necessary. During mid-childhood the hypothalamic-pituitary-gonadal (HPG) axis is quiescent and gonadotropins are usually unmeasurable. Nonetheless, this axis is active during infancy. Therefore, gonadotropins are measurable with peak values at 3 months of age and with lower (but still measurable) values at 9 months of age, in a period called the minipuberty. The aim of this study is to find markers of ovarian capacity, during the minipuberty, in order to predict ovarian reserve in the future.

Objective: The hormonal range of LH, FSH, AMH, inhibin B, testosterone and estradiol in girls with TS during the minipuberty and the relation of the hormone serum levels with the karyotype.

Study design: A prospective, cohort study with a duration of 3 years. Study population: Girls with a pre- or perinatal diagnosis TS who are born in a medical centre in the Netherlands during the duration of the study

Main study parameters/endpoints: Serum levels of FSH, LH, AMH, inhibin B, testosterone and estradiol at the age of 3 and 9 months.

Conditions

  • Turner Syndrome
  • Infertility, Female
  • Premature Ovarian Failure
  • Gonadal Dysgenesis
  • Premature Menopause
  • Sex Chromosome Disorders
  • Ovarian Diseases

Interventions

OTHER

Venapunction

A blood sample of 3.5 mL (0.2 mL serum for FSH and LH, 0.15 mL serum for E2, 0.15 mL serum for T, 0.15 mL serum for AMH and 0.25 mL serum for Inhibin B) will be collected of all girls with TS at 3 months and 9 months of age. For the girls with TS, this will be collected with an extra venapuncture during a regular outpatient visit within the usual care.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Janielle vd Velden, MD, PhD · Paediatric endocrinologist, Radboudumc, Nijmegen

Eligibility

Min Age
1 Month
Max Age
3 Months
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2024-12-01
Completion
2024-12-01

Countries

  • Denmark
  • Germany
  • Netherlands
  • Poland
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04189406 on ClinicalTrials.gov