Effects of Telomerase Reactivation With Danazol in Ovarian Function.
Condition: Ovarian Reserve
Study type: Interventional

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.
    

Intervention name(s): Danazol/Placebo; Without intervention
Intervention type(s): Drug; Other
Intervention description(s): 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.; Women with normal ovarian reserve will not be treated in anyway, thus, randomization will not be necessary.
Intervention MeSH terms: Danazol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A control group composed of women with normal ovarian reserve to compare telomeric and fertility parameters with the group with compromised ovarian reserve.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ovarian reserve.; Telomeric factor; Blood; Granulosa cells