Comparison Between Testosterone and Estradiol Over the Homogenization of Follicular Cohort

• Status: Unknown status
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

In vitro fertilization(IVF) with Gonadotropin-releasing hormone (GnRH) antagonist is one of the most used protocol for the treatment of infertile couples nowadays. Despite several advantages over GnRH agonist, the antagonist may be associated with a slightly reduction in pregnancy rates.

Several medications have been tested in order to increase ovarian response to ovulation induction, including estradiol and testosterone. A clinical trial in women with IVF indication will be performed and this women will be randomly assigned to receive topic testosterone, oral estradiol or no pre-treatment prior to IVF with human Chorionic Gonadotropin (hMG) and GnRH antagonist. The primary endpoint will be the size and number of follicles on the beginning of the cycle, after pre-treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Methyltestosterone; Polyestradiol phosphate; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Regular cycles (between 25-34 days)

• In vitro fertilization indication for male cause, unexplained infertility or tubal factor

• Both ovaries

• Thyroid-stimulating hormone(TSH) < 2,5 mU/L

• Anti-Müllerian hormone (AMH) between 1-5 ng/ml

• Body Mass Index (BMI) < 30

Exclusion Criteria:

• Ovarian surgery

• Endometriosis

• Endocrinology or metabolic disorder

• Polycystic ovary syndrome (PCOS)

• Poor Ovarian Response (according to Bologna criteria)