NCT00542126

Brief Summary

Supraphysiological hormonal stimulation enables collecting many oocytes in an In-Vitro Fertilization treatment, but may have a negative effect on uterine function and contribute the fact that the majority of preembryos placed in the uterus fail to implant. Several medical agents were shown to be beneficial when given in the luteal phase of an IVF cycle, but the optimal regimen has not been yet determined. In 2006, a European group reported that addition of GnRH analog (Decapeptyl) as luteal support in IVF cycle significantly improved pregnancy and delivery rates. It is not known whether this positive effect influences the corpus luteum, embryo or the uterus. The researchers sought to evaluate the effect of GnRH administration as luteal support in frozen-thaws IVF cycle.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 19, 2007

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

October 10, 2007

Status Verified

September 1, 2007

First QC Date

September 19, 2007

Last Update Submit

October 9, 2007

Conditions

Keywords

GnRH analog, IVF, infertility, frozen-thawed embryos

Outcome Measures

Primary Outcomes (1)

  • pregnancy and delivery rates

Study Arms (2)

1

ACTIVE COMPARATOR

GnRH analog administration following embryo transfer

Drug: Decapeptyl 0.1 mg after embryo transfer

2

NO INTERVENTION

Interventions

Decapeptyl 0.1 mg (Ferring, Kiel, Germany) 3 days following embryo transfer

1

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • IVF patients transfer of a minimum of two medium-quality thawed embryos in IVF

You may not qualify if:

  • Two or more fresh IVF embryo transfer or three or more thawed embryos transfer with no pregnancy.
  • maximal endometrial thickness \< 6 mm or intracavitary fluid at the time of embryo transfer on previous cycles
  • Untreated hydrosalpinges
  • intracavitary mass
  • submucous myoma
  • known allergy to one of medical agents used in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVF unit, Shaare-Zedek Medical Center

Jerusalem, 91031, Israel

Location

Related Publications (1)

  • 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

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

  • Avi Tsafrir, MD

    Shaare-Zedek Medical Center, Jerusalem, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Avi Tsafrir, MD

CONTACT

Ehud Margalioth, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2007

First Posted

October 10, 2007

Study Start

December 1, 2007

Study Completion

September 1, 2009

Last Updated

October 10, 2007

Record last verified: 2007-09

Locations