- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01205009
Human Chorionic Gonadotropin Supplementation Prior to In-vitro Fertilization Treatment in Poor Responders
March 1, 2011 updated by: Hadassah Medical Organization
In an era of delayed fertility plans, there is increasing need for fertility treatment in older women with poor response.
Human chorionic gonadotropin (hCG) supplementation prior to treatment, as a thecal stimulant, may improve folliculogenesis and ovarian response.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
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
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-
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Jerusalem, Israel
- Hadassah Medical Center
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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
40 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- women >39 years on IVF treatment
Exclusion Criteria:
- polycystic ovary syndrome
- Any allergy to injection of human chorionic gonadotropin before
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 |
|---|---|
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Active Comparator: Ovitrelle supplemantation
The women will be given 250 mcg of Ovitrelle prior to their IVF cycle
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One dose of Ovitrelle 250 mcg
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No Intervention: no Ovitrelle supplementation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
number of oocytes retrieved
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mushira Aboo Dia, MD, Hadassah Medical Organization
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
April 1, 2011
Primary Completion (Anticipated)
March 1, 2012
Study Registration Dates
First Submitted
August 30, 2010
First Submitted That Met QC Criteria
September 16, 2010
First Posted (Estimate)
September 20, 2010
Study Record Updates
Last Update Posted (Estimate)
March 2, 2011
Last Update Submitted That Met QC Criteria
March 1, 2011
Last Verified
September 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- hCGpoorresp-HMO-CTIL
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.