- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03044756
Omitting GnRH-antagonist Dose on the Day of Ovulation Trigger
February 6, 2017 updated by: Osama Saber Thabet Abdalmageed, Assiut University
Impact of Omitting GnR-antagonist on Ovulation Trigger Day in the Fresh Autologous IVF/ICSI Cycles
Omitting the GnRH antagonist on the day of the trigger can be cost effective and more convenient to the women.
We will study the impact of omitting the antagonist dose in a prospective randomized trial
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
- Phase 3
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
-
-
Non-US/Non-Canadian
-
Assiut, Non-US/Non-Canadian, Egypt, 71111
- Recruiting
- Osama Abdalmageed
-
-
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
20 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- All antagonist cycle ivf who agree to participate
Exclusion Criteria:
- expected poor responders.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: -ve arm
The women who do not receive the GnRH antagonist dose on the day of triggering of ovulation (omitted GnRH antagonist arm)
|
Omit Citrotide 0.25 dose on the day of triggering of ovulation
|
No Intervention: +ve arm
The women who receive the routine dose of GnRH antagonist on the day of triggering of ovulation (the usual protocol)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of retrieved oocytes
Time Frame: One Month
|
total number and maturation of the retrieved oocytes
|
One Month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
January 1, 2017
Primary Completion (Anticipated)
August 30, 2017
Study Completion (Anticipated)
December 30, 2017
Study Registration Dates
First Submitted
February 1, 2017
First Submitted That Met QC Criteria
February 6, 2017
First Posted (Estimate)
February 7, 2017
Study Record Updates
Last Update Posted (Estimate)
February 7, 2017
Last Update Submitted That Met QC Criteria
February 6, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Omit
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The regulations in Assiut University do not allow protected patient data sharing
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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