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Single Dose Gonadotropin-releasing Hormone (GnRH) Agonist Administration in the Luteal Phase of GnRH Antagonist Stimulated ICSI-ET Cycles

Primary Purpose

Infertility

Status
Terminated
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
triptorelin acetate
NaCl %0.9
Sponsored by
V.K.V. American Hospital, Istanbul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Infertility focused on measuring GnRH agonist, GnRH antagonist, IVF, ICSI, assisted reproduction, luteal phase

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • American Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GnRH agonist

Saline

Arm Description

Outcomes

Primary Outcome Measures

Ongoing pregnancy beyond 20th gestational week

Secondary Outcome Measures

clinical pregnancy rate
Embryo implantation rate

Full Information

First Posted
November 3, 2009
Last Updated
November 3, 2009
Sponsor
V.K.V. American Hospital, Istanbul
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1. Study Identification

Unique Protocol Identification Number
NCT01007851
Brief Title
Single Dose Gonadotropin-releasing Hormone (GnRH) Agonist Administration in the Luteal Phase of GnRH Antagonist Stimulated ICSI-ET Cycles
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Terminated
Why Stopped
Lower than anticipated recruitment
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
V.K.V. American Hospital, Istanbul

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
GnRH agonist, GnRH antagonist, IVF, ICSI, assisted reproduction, luteal phase

7. Study Design

Study Phase
Phase 3

8. Arms, Groups, and Interventions

Arm Title
GnRH agonist
Arm Type
Experimental
Arm Title
Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
triptorelin acetate
Intervention Description
single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer
Intervention Type
Drug
Intervention Name(s)
NaCl %0.9
Intervention Description
0.1 ml sterile saline sc injection 3 days after embryo transfer
Primary Outcome Measure Information:
Title
Ongoing pregnancy beyond 20th gestational week
Secondary Outcome Measure Information:
Title
clinical pregnancy rate
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 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.
Facility Information:
Facility Name
American Hospital
City
Istanbul
ZIP/Postal Code
34365
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Single Dose Gonadotropin-releasing Hormone (GnRH) Agonist Administration in the Luteal Phase of GnRH Antagonist Stimulated ICSI-ET Cycles

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