Back to resultsGnRH Agonist Administration in the Luteal Phase of ICSI-ET Cycles
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
triptorelin acetate
Na Cl %0.9
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring GnRH agonist, IVF/ICSI outcome, luteal phase
Eligibility Criteria
Inclusion Criteria:
- Women undergoing embryo transfer following controlled ovarian hyperstimulation with a long GnRH agonist 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.
Sites / Locations
- Amerikan Hastanesi Tüp Bebek Merkezi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
GnRH agonist administration
Sterile saline injection
Outcomes
Primary Outcome Measures
Ongoing pregnancy rate beyond 20 weeks
Secondary Outcome Measures
Clinical pregnancy
Embryo implantation rate
Full Information
NCT ID
NCT00516490
First Posted
August 14, 2007
Last Updated
August 14, 2007
Sponsor
V.K.V. American Hospital, Istanbul
1. Study Identification
Unique Protocol Identification Number
NCT00516490
Brief Title
GnRH Agonist Administration in the Luteal Phase of ICSI-ET Cycles
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
V.K.V. American Hospital, Istanbul
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A single dose GnRH agonist administration in the luteal phase of assisted reproduction cycles was reported to increase pregnancy and birth rates. This study was done to evaluate the reproducibility of previous findings.
Detailed Description
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 long GnRH agonist protocol. Women undergoing embryo transfer following controlled ovarian hyperstimulation with a long GnRH agonist 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
GnRH agonist, IVF/ICSI outcome, luteal phase
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
570 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
GnRH agonist administration
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Sterile saline injection
Intervention Type
Drug
Intervention Name(s)
triptorelin acetate
Other Intervention Name(s)
Decapeptyl Ferring GmBH Kiel Germany
Intervention Description
Single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer
Intervention Type
Drug
Intervention Name(s)
Na Cl %0.9
Other Intervention Name(s)
Isotonik NaCl %0.09 Eczacibasi-Baxter Istanbul Turkey
Intervention Description
0.1 ml sterile saline subcutaneous injection on the 3rd day after embryo transfer
Primary Outcome Measure Information:
Title
Ongoing pregnancy rate beyond 20 weeks
Secondary Outcome Measure Information:
Title
Clinical pregnancy
Title
Embryo implantation rate
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women undergoing embryo transfer following controlled ovarian hyperstimulation with a long GnRH agonist 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baris Ata, M.D.
Organizational Affiliation
The Assisted Reproduction Unit of the American Hospital of Istanbul
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bulent Urman, M.D.
Organizational Affiliation
The Assisted Reproduction Unit of the American Hospital of Istanbul
Official's Role
Study Director
Facility Information:
Facility Name
Amerikan Hastanesi Tüp Bebek Merkezi
City
Istanbul
ZIP/Postal Code
34365
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
16926261
Citation
Tesarik J, Hazout A, Mendoza-Tesarik R, Mendoza N, Mendoza C. Beneficial effect of luteal-phase GnRH agonist administration on embryo implantation after ICSI in both GnRH agonist- and antagonist-treated ovarian stimulation cycles. Hum Reprod. 2006 Oct;21(10):2572-9. doi: 10.1093/humrep/del173. Epub 2006 Aug 22.
Results Reference
background
PubMed Identifier
18192671
Citation
Ata B, Yakin K, Balaban B, Urman B. GnRH agonist protocol administration in the luteal phase in ICSI-ET cycles stimulated with the long GnRH agonist protocol: a randomized, controlled double blind study. Hum Reprod. 2008 Mar;23(3):668-73. doi: 10.1093/humrep/dem421. Epub 2008 Jan 12.
Results Reference
derived
Learn more about this trial
GnRH Agonist Administration in the Luteal Phase of ICSI-ET Cycles
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