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

NCT01007851 | Terminated Phase 3

• 1 other identifier: AH-48/07
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

GnRH agonist; GnRH antagonist; IVF; ICSI; assisted reproduction; luteal phase

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy beyond 20th gestational week

Secondary Outcomes (2)

• clinical pregnancy rate

• Embryo implantation rate

Study Arms (2)

GnRH agonist

EXPERIMENTAL

Drug: triptorelin acetate

Saline

PLACEBO COMPARATOR

Drug: NaCl %0.9

Interventions

triptorelin acetate DRUG

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

GnRH agonist

NaCl %0.9 DRUG

0.1 ml sterile saline sc injection 3 days after embryo transfer

Saline

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Participation in another trial that was being conducted in our unit at the same time.
• Preimplantation genetic screening cycles.
• Day 5 embryo transfers.

Sponsors & Collaborators

• V.K.V. American Hospital, Istanbul: lead

Study Sites (1)

American Hospital

Istanbul, 34365, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility

Interventions

Triptorelin Pamoate; Sodium Chloride

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 3, 2009
• First Posted: November 4, 2009
• Study Start: September 1, 2006
• Study Completion: December 1, 2007
• Last Updated: November 4, 2009

Record last verified: 2009-11

Locations

TU (1)