Transdermal Testosterone for Poor Responder Patients Undergoing Controlled Ovarian Stimulation Prior to IVF

Phase 4

• Conditions: Infertility, Female
• Interventions: Drug: Testosterone gel

• Registration Number: NCT03078569
• Lead Sponsor: Wolfson Medical Center

Brief Summary

This study evaluates the efficacy of pre- IVF treatment with transdermal testosterone to enhance ovarian response in poor responders.

a randomized controlled trial with two groups, treatment group with transdermal testosterone before IVF treatment and a control group with no treatment.

Detailed Description

One of the major challenges of Assisted reproduction technology is treating women with low ovarian response,those women achieve very poor pregnancy rate with IVF.

in recent years there is a focus

Study Timeline

• Status Verified: 2017-03
• Study Start: 2017-03
• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-08
• Last Update Submitted: 2017-03-08
• Study First Posted: 2017-03-13
• Last Update Posted: 2017-03-13
• Primary Completion: 2018-03
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• infertility patients undergoing ART regular menses normal function of thyroid, liver and kidney normal BMI (19.3-28.9) without use of any fertility drugs in the previous two months

Exclusion Criteria

• patients with recurrent implantations failure (3 cycles and more) previous ovarian surgery uncontrolled medical illness severe endometriosis (stage 3-4) contraindication for testosterone use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
testosterone gel	Testosterone gel	testosterone gel treatment group

Primary Outcome Measures

Name	Time	Method
number of retrieved oocytes	2 year	number of oocytes

Secondary Outcome Measures

Name	Time	Method
number of clinical pregnancies	2.5 years	number of pregnancies with fetal cardiac activity

Trial Locations

Locations (1)

Wolfson MC; 🇮🇱 Holon, Israel