NCT00516490

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
570

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2007

Completed
Last Updated

August 15, 2007

Status Verified

August 1, 2007

First QC Date

August 14, 2007

Last Update Submit

August 14, 2007

Conditions

Keywords

GnRH agonistIVF/ICSI outcomeluteal phase

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate beyond 20 weeks

Secondary Outcomes (2)

  • Clinical pregnancy

  • Embryo implantation rate

Study Arms (2)

1

EXPERIMENTAL

GnRH agonist administration

Drug: triptorelin acetate

2

PLACEBO COMPARATOR

Sterile saline injection

Drug: Na Cl %0.9

Interventions

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

Also known as: Decapeptyl Ferring GmBH Kiel Germany
1

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

Also known as: Isotonik NaCl %0.09 Eczacibasi-Baxter Istanbul Turkey
2

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Participation in another trial that was being conducted in our unit at the same time.
  • Preimplantation genetic screening cycles.
  • Day 5 embryo transfers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amerikan Hastanesi Tüp Bebek Merkezi

Istanbul, 34365, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 16926261BACKGROUND
  • 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.

MeSH Terms

Conditions

Infertility

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Baris Ata, M.D.

    The Assisted Reproduction Unit of the American Hospital of Istanbul

    PRINCIPAL INVESTIGATOR
  • Bulent Urman, M.D.

    The Assisted Reproduction Unit of the American Hospital of Istanbul

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 14, 2007

First Posted

August 15, 2007

Study Start

September 1, 2006

Study Completion

July 1, 2007

Last Updated

August 15, 2007

Record last verified: 2007-08

Locations