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

Sponsor

V.K.V. American Hospital, Istanbul (Other)

Overall Status

Terminated

CT.gov ID

NCT01007851

Collaborator

(none)

Location

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: triptorelin acetate Drug: NaCl %0.9	Phase 3

Study Design

Study Type:

Interventional

Study Start Date :

Sep 1, 2006

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GnRH agonist	Drug: triptorelin acetate single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer
Placebo Comparator: Saline	Drug: NaCl %0.9 0.1 ml sterile saline sc injection 3 days after embryo transfer

Arm

Intervention/Treatment

Experimental: GnRH agonist

Drug: triptorelin acetate

single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer

Placebo Comparator: Saline

Drug: NaCl %0.9

0.1 ml sterile saline sc injection 3 days after embryo transfer

Outcome Measures

Primary Outcome Measures

Ongoing pregnancy beyond 20th gestational week []

Secondary Outcome Measures

clinical pregnancy rate []
Embryo implantation rate []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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