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Luteal-Phase GnRH Agonist Administration in Frozen-Thawed IVF Embryo Transfer Cycles

NCT ID: NCT00542126

Last Updated: 2007-10-10

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

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy Rate

Keywords

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GnRH analog, IVF, infertility, frozen-thawed embryos

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

GnRH analog administration following embryo transfer

Group Type ACTIVE_COMPARATOR

Decapeptyl 0.1 mg after embryo transfer

Intervention Type DRUG

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

2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Decapeptyl 0.1 mg after embryo transfer

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Avi Tsafrir, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare-Zedek Medical Center, Jerusalem, Israel

Locations

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IVF unit, Shaare-Zedek Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Avi Tsafrir, MD

Role: CONTACT

Phone: 972-508573805

Email: [email protected]

Ehud Margalioth, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Avi Tsafrir, MD

Role: primary

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)

Other Identifiers

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GnRHFETsupport.CTIL

Identifier Type: -

Identifier Source: org_study_id