Back to resultsTransdermal Testosterone for Poor Responder Patients Undergoing Controlled Ovarian Stimulation Prior to IVF
Primary Purpose
Infertility, Female
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Testosterone gel
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Female focused on measuring Poor responders
Eligibility 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
Sites / Locations
- Wolfson MCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
testosterone gel
Control group
Arm Description
testosterone gel treatment group
without testosterone treatment
Outcomes
Primary Outcome Measures
number of retrieved oocytes
number of oocytes
Secondary Outcome Measures
number of clinical pregnancies
number of pregnancies with fetal cardiac activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03078569
Brief Title
Transdermal Testosterone for Poor Responder Patients Undergoing Controlled Ovarian Stimulation Prior to IVF
Official Title
Transdermal Testosterone for Poor Responders Undergoing IVF
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2017 (Anticipated)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wolfson Medical Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
Poor responders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
testosterone gel
Arm Type
Experimental
Arm Description
testosterone gel treatment group
Arm Title
Control group
Arm Type
No Intervention
Arm Description
without testosterone treatment
Intervention Type
Drug
Intervention Name(s)
Testosterone gel
Other Intervention Name(s)
testomax
Intervention Description
treatment with testosterone gel
Primary Outcome Measure Information:
Title
number of retrieved oocytes
Description
number of oocytes
Time Frame
2 year
Secondary Outcome Measure Information:
Title
number of clinical pregnancies
Description
number of pregnancies with fetal cardiac activity
Time Frame
2.5 years
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
only women under IVF treatment
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
amir Mr shalev, MD
Phone
97235028105
Email
amirshalev75@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
ariel Mr weissman, Proffesor
Phone
97235028106
Email
ariel.weissman@gmail.com
Facility Information:
Facility Name
Wolfson MC
City
Holon
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Mr shalev, MD
Phone
97235028105
Email
amirshalev75@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transdermal Testosterone for Poor Responder Patients Undergoing Controlled Ovarian Stimulation Prior to IVF
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