NCT04058678

Effects of Telomerase Reactivation With Danazol in Ovarian Function.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: IVI Madrid · Academic / Other
• Sex: Female
• Age: 30 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This project explores the implication of the telomere pathway in ovarian premature and regular aging. Telomere length and maintenance underlie several biological processes such cancer, aging, human diseases and the biology of stem cells. The reactivation of telomerase should lead to a rejuvenation of the ovarian tissue and the improvement of fertility. The correlation of telomeric factors in blood and granulosa cells will be studied with the aim of finding telomeric biomarkers of ovarian aging.

Detailed description

This is a pilot study, randomized, controled, blind, parallelo arm clinical trial with inactive substance and medicine. A pilot study will be developed with a total of 45 individuals from 30 to 45 years old, who represent the most frequent population of women seeking for ART. A control group composed of women with normal ovarian reserve (30 to 45 years old) is needed to compare telomeric and fertility parameters with the group of women with compromised ovarian reserve. Women in the control group irrespective of their age, will have a greater number of follicles compared to women belonging to the group with compromised ovarian reserve. A group of women with diminished ovarian reserve that will take an inactive substance has been incluided to avoid biases and to set the fertility base line for women with compromised ovarian reserve. The use of an inactive substance or placebo will help obtain better quality results. For instance, if Danazol happened to improve the fertility outcome, then, there could be a possibility that the IVF improvement might be due to other components of the pill. Using placebo, this possibility would be eliminated, since the placebo will contain all components of the pill, except Danazol. The development of a pilot study will help us understand the statisticl behavior or the telomeric factors as well as to determine the appropriate number of individuals that shoyuld be recruited in a clinical trial to have results with statistical significance. In addition, a pilot study will help us learn errors or undesired events that may happen during the clinical trial. For instance, if patients cannot follow the indications of their doctors and why, or what proportion of patients will drop the study and the reasons for it. Furthermore, it will also help us understand if there exist a tendency, an indication or even a clear beneficial effect for patients without harming them. The number of participants selected for the study is considered adequate for each group, since each group will be measured in an independent manner.

Conditions

• Ovarian Reserve

Interventions

Type	Name	Description
DRUG	Danazol/Placebo	This group will be randomized 1:1 for either inactive substance or Danazol, according to a computer-generated randomization list prepared. Women will be treated with Danazol/Placebo oral way for 3 months.
OTHER	Without intervention	Women with normal ovarian reserve will not be treated in anyway, thus, randomization will not be necessary.

Timeline

• Start date: 2020-01-30
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2019-08-15
• Last updated: 2022-08-10

Locations

1 site across 1 country: Spain