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

Infertility Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00516490
• Other study ID #: AH-47/07
• Status: Completed
• Phase: N/A
• First received: August 14, 2007
• Last updated: August 14, 2007
• Start date: September 2006
• Est. completion date: July 2007

Study information

• Verified date: August 2007
• Source: V.K.V. American Hospital, Istanbul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 570
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• triptorelin acetate
Single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer
• Na Cl %0.9
0.1 ml sterile saline subcutaneous injection on the 3rd day after embryo transfer

Locations

Country	Name	City	State
Turkey	Amerikan Hastanesi Tüp Bebek Merkezi	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
V.K.V. American Hospital, Istanbul

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. Epub 2006 Aug 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate beyond 20 weeks
Secondary	Clinical pregnancy
Secondary	Embryo implantation rate