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

NCT ID: NCT00516490

Last Updated: 2007-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

570 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

GnRH agonist administration

Group Type EXPERIMENTAL

triptorelin acetate

Intervention Type DRUG

Single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer

2

Sterile saline injection

Group Type PLACEBO_COMPARATOR

Na Cl %0.9

Intervention Type DRUG

0.1 ml sterile saline subcutaneous injection on the 3rd day after embryo transfer

Interventions

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triptorelin acetate

Single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer

Intervention Type DRUG

Na Cl %0.9

0.1 ml sterile saline subcutaneous injection on the 3rd day after embryo transfer

Intervention Type DRUG

Other Intervention Names

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Decapeptyl Ferring GmBH Kiel Germany Isotonik NaCl %0.09 Eczacibasi-Baxter Istanbul Turkey

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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V.K.V. American Hospital, Istanbul

OTHER

Sponsor Role lead

Principal Investigators

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Baris Ata, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Assisted Reproduction Unit of the American Hospital of Istanbul

Bulent Urman, M.D.

Role: STUDY_DIRECTOR

The Assisted Reproduction Unit of the American Hospital of Istanbul

Locations

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Amerikan Hastanesi Tüp Bebek Merkezi

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Tesarik J, Hazout A, Mendoza-Tesarik R, Mendoza N, Mendoza C. Beneficial effect of luteal-phase GnRH agonist administration on embryo implantation after ICSI in both GnRH agonist- and antagonist-treated ovarian stimulation cycles. Hum Reprod. 2006 Oct;21(10):2572-9. doi: 10.1093/humrep/del173. Epub 2006 Aug 22.

Reference Type BACKGROUND
PMID: 16926261 (View on PubMed)

Ata B, Yakin K, Balaban B, Urman B. GnRH agonist protocol administration in the luteal phase in ICSI-ET cycles stimulated with the long GnRH agonist protocol: a randomized, controlled double blind study. Hum Reprod. 2008 Mar;23(3):668-73. doi: 10.1093/humrep/dem421. Epub 2008 Jan 12.

Reference Type DERIVED
PMID: 18192671 (View on PubMed)

Other Identifiers

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AH-47/07

Identifier Type: -

Identifier Source: org_study_id