- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03078569
Transdermal Testosterone for Poor Responder Patients Undergoing Controlled Ovarian Stimulation Prior to IVF
Transdermal Testosterone for Poor Responders Undergoing IVF
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.
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Amir Mr shalev, MD
- Phone Number: 97235028105
- Email: amirshalev75@yahoo.com
Study Contact Backup
- Name: ariel Mr weissman, Proffesor
- Phone Number: 97235028106
- Email: ariel.weissman@gmail.com
Study Locations
-
-
-
Holon, Israel
- Recruiting
- Wolfson MC
-
Contact:
- Amir Mr shalev, MD
- Phone Number: 97235028105
- Email: amirshalev75@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: testosterone gel
testosterone gel treatment group
|
treatment with testosterone gel
Other Names:
|
No Intervention: Control group
without testosterone treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of retrieved oocytes
Time Frame: 2 year
|
number of oocytes
|
2 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of clinical pregnancies
Time Frame: 2.5 years
|
number of pregnancies with fetal cardiac activity
|
2.5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- wolfson testosterone 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infertility, Female
-
Esraa Gamal AhmedAin Shams Maternity HospitalUnknownUnexplained Female Infertility
-
Pacific Fertility CenterTerminatedPrimary Female Infertility | Secondary Female Infertility
-
Assuta Hospital SystemsMaccabi Healthcare Services, IsraelCompletedInfertility, Female Infertility, Male InfertilityIsrael
-
Newlife Fertility CentreRecruitingInfertility | Infertility,Female | Infertility Unexplained | Infertility of Uterine Origin | Infertility; Female, NonimplantationCanada
-
Cairo UniversityCompleted
-
Navy General Hospital, BeijingUnknownFemale Infertility Due to Nonimplantation of OvumChina
-
Wake Forest University Health SciencesWithdrawnUterine Diseases | Endometriosis | Infertility Unexplained | Endometrial Diseases | Infertility; Female, NonimplantationUnited States
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedPregnancy | Male Infertility | Female InfertilityNetherlands
-
Sapientiae InstituteTerminated
-
Woman's Health University Hospital, EgyptCompletedFemale Infertility Due to Diminished Ovarian ReserveEgypt
Clinical Trials on Testosterone gel
-
University of WashingtonNational Institutes of Health (NIH); National Institute on Aging (NIA)CompletedHealthyUnited States
-
Biolab Sanus FarmaceuticaWithdrawnPost-menopausal Period
-
VA Office of Research and DevelopmentRecruiting
-
BioSante PharmaceuticalsCompletedHypoactive Sexual Desire DisorderUnited States, Canada
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
-
Acerus Pharmaceuticals CorporationCompletedFemale Sexual DysfunctionUnited States
-
University of WashingtonNational Institute on Aging (NIA); Solvay PharmaceuticalsCompletedMild Cognitive Impairment | Alzheimer's DiseaseUnited States
-
University of PennsylvaniaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
-
McGuire Research InstituteSolvay PharmaceuticalsCompletedMetabolic Syndrome | HypogonadismUnited States
-
University Medical Center GroningenActive, not recruiting