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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03078569
Other study ID # wolfson testosterone 1
Secondary ID
Status Recruiting
Phase Phase 4
First received March 8, 2017
Last updated March 8, 2017
Start date March 2017
Est. completion date July 2018

Study information

Verified date March 2017
Source Wolfson Medical Center
Contact amir Mr shalev, MD
Phone 97235028105
Email amirshalev75@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date July 2018
Est. primary completion date March 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 42 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Testosterone gel
treatment with testosterone gel

Locations

Country Name City State
Israel Wolfson MC Holon

Sponsors (1)

Lead Sponsor Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of retrieved oocytes number of oocytes 2 year
Secondary number of clinical pregnancies number of pregnancies with fetal cardiac activity 2.5 years
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