NCT02549690

Testosterone Gel in Poor Responders Undergoing IVF

Effectiveness of Testosterone Gel Pretreatment in Poor Responders Undergoing IVF Treatment: a Randomized Controlled Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vietnam National University · Academic / Other
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to compare the number of oocytes retrieved after using transdermal testosterone gel 10 mg per day or Dehydroepiandrosterone (DHEA) 75mg per day for 6-8 weeks as pre-treatment for poor ovarian responders undergoing in-vitro fertilization (IVF).

Detailed description

A randomized controlled multiple centers study. The study is designed as a superiority trial. The sample size for this trial of 120 subjects in both groups, based upon the primary endpoint of the number of oocytes retrieved. IVF patients who have failed to conceive and had poor ovarian response (oocytes retrieved ≤ 3) in the last stimulated cycle though using the maximal dose, which is ≥ 300 IU Follicle-stimulating hormone (FSH) or human menopausal gonadotropin (hMG). Patients will be randomized to use DHEA or testosterone gel as pretreatment. Randomization will be performed using sealed envelopes developed via a computer generated list with blocks of four. Doctors will be blinded to the randomization, but not patients and nurses. * Study group 1 use 10 mg transdermal testosterone gel per day. * Study group 2 use 75mg DHEA per day. Serum testosterone are measured before treatment. Duration of androgen supplement is 6-8 weeks. After completing the pretreatment, patients are asked to come back when they have menses to begin IVF treatment. Serum testosterone is measured again after the pretreatment in both groups. Patients will be interviewed for side effects and compliance of treatment. After treatment, patients in both group undergo IVF treatment. IVF treatment will then be performed for all patients, according to the current hospital treatment protocols. Patients will be followed up until 7th week of gestation, if they have positive pregnancy test after embryo transfer. Data Analysis and Statistics: The investigators use Statistical Package for the Social Sciences (SPSS) software 20th version to analyze data. The primary end-point mean of number of retrieved oocytes will be compared between two groups using the Student's t test. The secondary end-points will also be compared between the 2 groups using either the Student's t test or chi-square test.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	Testosterone gel	Apply 10mg testosterone gel to the abdomen and rub on with one finger, once a day, in the morning, then allow sites to dry and cover with clothing. Continue the treatment for 6-8 weeks until next IVF treatment.
DRUG	DHEA	Take DHEA 25mg tablet orally, three times per day. Continue the treatment for 6-8 weeks, until next IVF treatment.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-05-01
• Completion: 2016-08-01
• First posted: 2015-09-15
• Last updated: 2017-04-18

Locations

1 site across 1 country: Vietnam