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

Infertility Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01007851
• Other study ID #: AH-48/07
• Status: Terminated
• Phase: Phase 3
• First received: November 3, 2009
• Last updated: November 3, 2009
• Start date: September 2006
• Est. completion date: December 2007

Study information

• Verified date: November 2009
• 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: December 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 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.

Study Design

N/A

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
• NaCl %0.9
0.1 ml sterile saline sc injection 3 days after embryo transfer

Locations

Country	Name	City	State
Turkey	American Hospital	Istanbul

Sponsors (1)

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

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy beyond 20th gestational week			No
Secondary	clinical pregnancy rate			No
Secondary	Embryo implantation rate			No