Turner Syndrome Clinical Trial
Official title:
Cryopreservation of Ovarian Cortex in Girls With Turner Syndrome : Karyotypic, Clinical and Hormonal Criteria to Screen Patients
Ovarian insufficiency is common in Turner syndrome related to premature and rapid follicular apoptosis and spontaneous pregnancies are rare in this population. Ovarian cryopreservation has been used in an effort to preserve fertility in patients undergoing treatments which lead to premature and severe ovarian insufficiency. This study aims to assess the relevance of ovarian tissue cryopreservation in girls with Turner syndrome. Based on ovarian follicular density as primary outcome and karyotypic, clinical and hormonal markers as secondary outcomes, analysis of the study will allow to select the patients to whom the procedure would benefit the most.
Turner syndrome (TS) is characterized by the absence of all or part of a normal second X chromosome and occurs in about 1/2,500 live-born girls. Spontaneous fertility is rare among patients with TS related to premature apoptosis of ovarian follicles. Spontaneous puberty and fertility has been reported mostly in patients with mosaic karyotype or small X deletions. There is robust evidence that follicles can be observed in ovaries in girls with TS. However, follicular density and quality seems to be largely influenced by karyotype, ovarian morphology and endocrine competence. There are no clear-cut clinical or hormonal markers to assess the ovarian reserve in girls with TS but markers of ovarian function used in women with premature ovarian insufficiency are measured. In TS, it is now fundamental to be able to evaluate the prognosis of the ovarian function and the degree of fertility to provide the relevant information to girls and their parents and to discuss possibilities of motherhood if any. Ovarian cryopreservation has been used in an effort to preserve fertility in patients undergoing treatments which lead to premature and severe ovarian insufficiency. This study aims to assess the relevance of ovarian tissue cryopreservation in girls with Turner syndrome. Based on ovarian follicular density as primary outcome and karyotypic, clinical and hormonal markers as secondary outcomes, analysis of the study will allow to screen the patients to whom the procedure would benefit the most. Girls who will be operated will accept to come for a follow-up visit at one and 12 months after the surgery. It is expected to have clinical and hormonal information through a long follow up performed by the referred paediatrician. Results of the study will allow us to select patients with TS who will benefit the most of this fertility preservation procedure based on karyotypic, clinical and hormonal profile. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01734486 -
Growth Response in Girls With Turner Syndrome
|
Phase 4 | |
| Completed |
NCT01678261 -
X-chromosome Inactivation, Epigenetics and the Transcriptome
|
N/A | |
| Completed |
NCT01419249 -
First Year Growth Response Associated Genetic Markers Validation Phase IV Open-label Study in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children: the PREDICT Pharmacogenetics Validation Study
|
Phase 4 | |
| Completed |
NCT01518036 -
Use of Somatropin in Turner Syndrome
|
Phase 3 | |
| Recruiting |
NCT04948658 -
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
|
||
| Completed |
NCT01563926 -
Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency
|
Phase 3 | |
| Completed |
NCT02787486 -
Expanded Noninvasive Genomic Medical Assessment: The Enigma Study
|
||
| Completed |
NCT00877942 -
Sex Differences in Early Brain Development; Brain Development in Turner Syndrome
|
N/A | |
| Completed |
NCT00825617 -
Quantitative Liver Functions in Turner Syndrome With and Without Hormone Replacement Therapy
|
N/A | |
| Recruiting |
NCT04463316 -
GROWing Up With Rare GENEtic Syndromes
|
||
| Enrolling by invitation |
NCT03836300 -
Parent and Infant Inter(X)Action Intervention (PIXI)
|
N/A | |
| Completed |
NCT01245374 -
Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents
|
Phase 4 | |
| Completed |
NCT01322165 -
National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions
|
N/A | |
| Terminated |
NCT00419107 -
Beta Cell Function in Women With Turner Syndrome
|
N/A | |
| Active, not recruiting |
NCT00625001 -
Long Term Follow-up of Bone Mineral Density in Hormone Treated Turner Syndrome
|
N/A | |
| Completed |
NCT00029159 -
The Effect of Androgen and Growth Hormone on Height and Learning in Girls With Turner Syndrome
|
Phase 3 | |
| Completed |
NCT01518062 -
Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome
|
Phase 4 | |
| Completed |
NCT00471731 -
Dry Eye in Women With Turner Syndrome and Women With Premature Ovarian Failure
|
N/A | |
| Completed |
NCT00256126 -
Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®
|
Phase 4 | |
| Completed |
NCT03181230 -
Health, Fitness, and Quality of Life in Adolescent Girls With Turner Syndrome
|