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

This study has been terminated.
(Lower than anticipated recruitment)
Sponsor:
Information provided by:
V.K.V. American Hospital, Istanbul
ClinicalTrials.gov Identifier:
NCT01007851
First received: November 3, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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 Intervention Phase
Infertility
Drug: triptorelin acetate
Drug: NaCl %0.9
Phase 3

Study Type: Interventional

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Ongoing pregnancy beyond 20th gestational week [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical pregnancy rate [ Designated as safety issue: No ]
  • Embryo implantation rate [ Designated as safety issue: No ]

Study Start Date: September 2006
Study Completion Date: December 2007
Arms Assigned Interventions
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

  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007851

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

No publications provided

ClinicalTrials.gov Identifier: NCT01007851     History of Changes
Other Study ID Numbers: AH-48/07
Study First Received: November 3, 2009
Last Updated: November 3, 2009
Health Authority: Turkey: Ministry of Health

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

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

ClinicalTrials.gov processed this record on August 20, 2014