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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00542126
Recruitment Status : Unknown
Verified September 2007 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 10, 2007
Last Update Posted : October 10, 2007
Information provided by:
Shaare Zedek Medical Center

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.

Condition or disease Intervention/treatment Phase
Pregnancy Rate Drug: Decapeptyl 0.1 mg after embryo transfer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2007
Estimated Study Completion Date : September 2009

Arm Intervention/treatment
Active Comparator: 1
GnRH analog administration following embryo transfer
Drug: Decapeptyl 0.1 mg after embryo transfer
Decapeptyl 0.1 mg (Ferring, Kiel, Germany) 3 days following embryo transfer

No Intervention: 2

Primary Outcome Measures :
  1. pregnancy and delivery rates

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00542126

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Contact: Avi Tsafrir, MD 972-508573805
Contact: Ehud Margalioth, MD

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IVF unit, Shaare-Zedek Medical Center
Jerusalem, Israel, 91031
Contact: Avi Tsafrir, MD    972-508573805   
Principal Investigator: Avi Tsafrir, MD         
Sponsors and Collaborators
Shaare Zedek Medical Center
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Principal Investigator: Avi Tsafrir, MD Shaare-Zedek Medical Center, Jerusalem, Israel

Layout table for additonal information Identifier: NCT00542126    
Other Study ID Numbers: GnRHFETsupport.CTIL
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: October 10, 2007
Last Verified: September 2007
Keywords provided by Shaare Zedek Medical Center:
GnRH analog, IVF, infertility, frozen-thawed embryos
Additional relevant MeSH terms:
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Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents