drugset / Trial / NCT03238092

Comparison Between Testosterone and Estradiol Over the Homogenization of Follicular Cohort

NCT03238092

Phase 3 Unknown 26 enrolled Hospital de Clinicas de Porto Alegre
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-08
Primary completion
2018-01
Completion
2018-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Estradiol Other / unclassified 4 mg Oral
Subject Testosterone Small molecule 25 mg Other

Indications