GnRH Agonist Administration in the Luteal Phase of ICSI-ET Cycles

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT00516490

Collaborator

(none)

570

Enrollment

Location

Arms

Duration (Months)

57.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: triptorelin acetate Drug: Na Cl %0.9	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

570 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Sep 1, 2006

Actual Study Completion Date :

Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 GnRH agonist administration	Drug: triptorelin acetate Single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer Other Names: Decapeptyl Ferring GmBH Kiel Germany
Placebo Comparator: 2 Sterile saline injection	Drug: Na Cl %0.9 0.1 ml sterile saline subcutaneous injection on the 3rd day after embryo transfer Other Names: Isotonik NaCl %0.09 Eczacibasi-Baxter Istanbul Turkey

Arm

Intervention/Treatment

Experimental: 1

GnRH agonist administration

Drug: triptorelin acetate

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

Other Names:

Decapeptyl Ferring GmBH Kiel Germany

Placebo Comparator: 2

Sterile saline injection

Drug: Na Cl %0.9

0.1 ml sterile saline subcutaneous injection on the 3rd day after embryo transfer

Other Names:

Isotonik NaCl %0.09 Eczacibasi-Baxter Istanbul Turkey

Outcome Measures

Primary Outcome Measures

Ongoing pregnancy rate beyond 20 weeks []

Secondary Outcome Measures

Clinical pregnancy []
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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amerikan Hastanesi Tüp Bebek Merkezi	Istanbul		Turkey	34365

Sponsors and Collaborators

V.K.V. American Hospital, Istanbul

Investigators

Principal Investigator: Baris Ata, M.D., The Assisted Reproduction Unit of the American Hospital of Istanbul
Study Director: Bulent Urman, M.D., The Assisted Reproduction Unit of the American Hospital of Istanbul