Infertility, Female Clinical Trial
Official title:
Assess the Effect of DHEA or Other Androgenic Agents on Ovarian Reserve Markers in Women With Diminished Ovarian Reserve
This study was conducted to evaluate the effect of a continuous administration of dehydroepiandrosterone (DHEA) or other androgenic agents on ovarian reserve markers in women with diminished ovarian reserve (ROD), such as antral follicle count (AFC) and anti-Müllerian hormone (AMH) concentrations.
Healthy women attending the clinic of the Mother and Health Research Institute (IDIMI) were
invited to participate, if they could not become pregnant due to surgical sterilization, and
if they presented no contraindications to use androgen therapy.
Project Objectives :
The general objective was to evaluate pharmacokinetic parameters of three vaginal rings
containing DHEA, testosterone, or combination of both hormones in women.
Secondary objectives were to assess effects on the hormonal profile, tolerability and
incidence of adverse events.
- DHEA and/or, testosterone levels
- Estradiol, follicle stimulating hormone (FSH), sex hormone binding globulin (SHBG),
androstenedione, morning cortisol, insulin growth factor 1 (IGF-1) levels
- Tolerability and safety assessment by the use of the vaginal ring.
- The incidence of adverse events
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