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

This study has been completed.
Sponsor:
Information provided by:
V.K.V. American Hospital, Istanbul
ClinicalTrials.gov Identifier:
NCT00516490
First received: August 14, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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 Intervention
Infertility
Drug: triptorelin acetate
Drug: Na Cl %0.9

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

Resource links provided by NLM:


Further study details as provided by V.K.V. American Hospital, Istanbul:

Primary Outcome Measures:
  • Ongoing pregnancy rate beyond 20 weeks

Secondary Outcome Measures:
  • Clinical pregnancy
  • Embryo implantation rate

Enrollment: 570
Study Start Date: September 2006
Study Completion Date: July 2007
Arms Assigned Interventions
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 Name: 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 Name: Isotonik NaCl %0.09 Eczacibasi-Baxter Istanbul Turkey

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516490

Locations
Turkey
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00516490     History of Changes
Other Study ID Numbers: AH-47/07
Study First Received: August 14, 2007
Last Updated: August 14, 2007
Health Authority: Turkey: Ministry of Health

Keywords provided by V.K.V. American Hospital, Istanbul:
GnRH agonist
IVF/ICSI outcome
luteal phase

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Triptorelin
Deslorelin
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014