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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00516490
First Posted: August 15, 2007
Last Update Posted: August 15, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
V.K.V. American Hospital, Istanbul
  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: Triple (Participant, 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

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: August 14, 2007
First Posted: August 15, 2007
Last Update Posted: August 15, 2007
Last Verified: August 2007

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
Deslorelin
Triptorelin Pamoate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents