GnRH Agonist Administration in the Luteal Phase of ICSI-ET Cycles
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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 |
- Ongoing pregnancy rate beyond 20 weeks
- 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 |
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| Turkey | |
| Amerikan Hastanesi Tüp Bebek Merkezi | |
| Istanbul, Turkey, 34365 | |
| 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 May 23, 2013