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

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ClinicalTrials.gov Identifier: NCT01007851
Recruitment Status : Terminated (Lower than anticipated recruitment)
First Posted : November 4, 2009
Last Update Posted : November 4, 2009
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Infertility Drug: triptorelin acetate Drug: NaCl %0.9 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Study Start Date : September 2006
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: GnRH agonist Drug: triptorelin acetate
single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer
Placebo Comparator: Saline Drug: NaCl %0.9
0.1 ml sterile saline sc injection 3 days after embryo transfer

Outcome Measures

Primary Outcome Measures :
  1. Ongoing pregnancy beyond 20th gestational week

Secondary Outcome Measures :
  1. clinical pregnancy rate
  2. Embryo implantation rate

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
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): NCT01007851

American Hospital
Istanbul, Turkey, 34365
Sponsors and Collaborators
V.K.V. American Hospital, Istanbul
More Information

ClinicalTrials.gov Identifier: NCT01007851     History of Changes
Other Study ID Numbers: AH-48/07
First Posted: November 4, 2009    Key Record Dates
Last Update Posted: November 4, 2009
Last Verified: November 2009

Keywords provided by V.K.V. American Hospital, Istanbul:
GnRH agonist
GnRH antagonist
assisted reproduction
luteal phase

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents