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

Overview

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.

Study Type

  • Study Type: Interventional

Interventions

  • Drug: triptorelin acetate
    • single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer
  • Drug: NaCl %0.9
    • 0.1 ml sterile saline sc injection 3 days after embryo transfer

Arms, Groups and Cohorts

  • Experimental: GnRH agonist
  • Placebo Comparator: Saline

Clinical Trial Outcome Measures

Primary Measures

  • Ongoing pregnancy beyond 20th gestational week

Secondary Measures

  • clinical pregnancy rate
  • Embryo implantation rate

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.