Effects of Telomerase Reactivation With Danazol in Ovarian Function.

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IVI Madrid
• Treatments: Danazol

Criteria

Inclusion Criteria:

• Provide signed and dated informed consent form.

• Willing to comply with all study procedures and be available for the duration of the study. This include the decisión to use contraception methods different to sexual hormones, such as the use of condoms, during the treatment with Danazol.

• In good general health as evidenced by medical history or diagnosed with body mass index between 18 and 30 kg/m2.

• Women with normal (AMH valued must be equal or higher tan 2ng/ml) or compromised ovarian reserve (defined as AMH < 2 ng/ml)

• Not having had any steroid hormones for one month.

Exclusion Criteria:

• Pregnancy o lactation.

• Taking other sexual hormones.

• Women with diseases in heart, liver or kidney or tumors which depend on male sexual hormones or hormone-dependent tumour.

• Women taking anticonvulsants, medicaments for diabetes, anticoagulants and anti-hypertension: ciclosporin and tacrolimus and other steroids and statins.

• Women suffering irregular genital bleeding or with thrombus or thromboembolicdiseases.

• Known allergic reactions to components of the study product (cornstarch and lactose).

• Having received ovulation induction drugs within one month before the inclusión in the study.

• Anything that would place the individual at increased risk or preclude the individual´s full compliance with or completion of the study.

• Simultaneous participation in another clinical trial or previous participation in this study.

• Participation in another clinical study 2 months before inclusión in the present study that could affect its objectives.