- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01016210
The Effect of Luteinizing Hormone (LH) Supplementation Following Gonadotropin-releasing Hormone (GnRH) Antagonist Administration in Advanced Reproductive Ageing Women Undergoing IVF and Embryo Transfer (IVF/ET)
January 16, 2014 updated by: The Baruch Padeh Medical Center, Poriya
To explore whether recombinant LH (rLH) supplementation (Leuveris) to recombinant follicle stimulating hormone (rFSH) following GnRH antagonist treatment has an advantage in infertile women with advanced reproductive ageing undergoing IVF-ET.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tiberias, Israel, 15208
- Poriya hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- female candidate to IVF
- between 30-45 years old
Exclusion Criteria:
- not included for fertilization
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: 60 infertile women
Candidates for IVF-ET treatment
|
IV
All recruited women will be treated similarly employing the recombinant FSH and the fixed GnRH antagonist.
Concomitantly, on the same day of the antagonist administration r-LH will be administered daily and continued until human chorionic gonadotropin (hCG) day.
|
No Intervention: control
no treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pregnancy rate
Time Frame: Starting February 2010
|
Starting February 2010
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fertilization rate
Time Frame: Starting February 2010 till April 2013
|
Starting February 2010 till April 2013
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
November 18, 2009
First Submitted That Met QC Criteria
November 18, 2009
First Posted (Estimate)
November 19, 2009
Study Record Updates
Last Update Posted (Estimate)
January 17, 2014
Last Update Submitted That Met QC Criteria
January 16, 2014
Last Verified
January 1, 2014
More Information
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.
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