- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01007851
Single Dose Gonadotropin-releasing Hormone (GnRH) Agonist Administration in the Luteal Phase of GnRH Antagonist Stimulated ICSI-ET Cycles
November 3, 2009 updated by: V.K.V. American Hospital, Istanbul
GnRH agonist administration in the luteal phase was reported to beneficially affect clinical outcome of ICSI-ET cycles.
This randomized controlled trial evaluates the effect of a single dose GnRH agonist administered in the luteal phase on the outcome of ICSI - ET cycles stimulated with the fixed GnRH antagonist protocol.
Women undergoing embryo transfer following controlled ovarian hyperstimulation with a fixed GnRH antagonist protocol were included.
In addition to routine luteal phase support with progesterone women were randomized to receive a single dose of GnRH agonist or placebo on the sixth day after ICSI.Ongoing pregnancy rate was the primary outcome measure.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- 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
-
-
-
Istanbul, Turkey, 34365
- American 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
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women undergoing embryo transfer following controlled ovarian hyperstimulation with a fixed GnRH antagonist protocol, oocyte pick-up and ICSI.
- Embryo transfer performed on day 3
Exclusion Criteria:
- Participation in another trial that was being conducted in our unit at the same time.
- Preimplantation genetic screening cycles.
- Day 5 embryo transfers.
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?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Saline
|
0.1 ml sterile saline sc injection 3 days after embryo transfer
|
Experimental: GnRH agonist
|
single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Ongoing pregnancy beyond 20th gestational week
|
Secondary Outcome Measures
Outcome Measure |
---|
Embryo implantation rate
|
clinical pregnancy rate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this 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
September 1, 2006
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
November 3, 2009
First Submitted That Met QC Criteria
November 3, 2009
First Posted (Estimate)
November 4, 2009
Study Record Updates
Last Update Posted (Estimate)
November 4, 2009
Last Update Submitted That Met QC Criteria
November 3, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AH-48/07
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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