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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03078569
Recruitment Status : Unknown
Verified March 2017 by amir shalev, Wolfson Medical Center.
Recruitment status was:  Recruiting
First Posted : March 13, 2017
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
amir shalev, 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.


Condition or disease Intervention/treatment Phase
Infertility, Female Drug: Testosterone gel Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transdermal Testosterone for Poor Responders Undergoing IVF
Estimated Study Start Date : March 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: testosterone gel
testosterone gel treatment group
Drug: Testosterone gel
treatment with testosterone gel
Other Name: testomax

No Intervention: Control group
without testosterone treatment



Primary Outcome Measures :
  1. number of retrieved oocytes [ Time Frame: 2 year ]
    number of oocytes


Secondary Outcome Measures :
  1. number of clinical pregnancies [ Time Frame: 2.5 years ]
    number of pregnancies with fetal cardiac activity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   only women under IVF treatment
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078569


Contacts
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Contact: amir Mr shalev, MD 97235028105 amirshalev75@yahoo.com
Contact: ariel Mr weissman, Proffesor 97235028106 ariel.weissman@gmail.com

Locations
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Israel
Wolfson MC Recruiting
Holon, Israel
Contact: Amir Mr shalev, MD    97235028105    amirshalev75@yahoo.com   
Sponsors and Collaborators
Wolfson Medical Center

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Responsible Party: amir shalev, MD, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT03078569    
Other Study ID Numbers: wolfson testosterone 1
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by amir shalev, Wolfson Medical Center:
Poor responders
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents