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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Shaare Zedek Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00542126
First received: September 19, 2007
Last updated: October 9, 2007
Last verified: September 2007
  Purpose

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 Intervention
Pregnancy Rate
Drug: Decapeptyl 0.1 mg after embryo transfer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • pregnancy and delivery rates

Study Start Date: December 2007
Estimated Study Completion Date: September 2009
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542126

Contacts
Contact: Avi Tsafrir, MD 972-508573805 avits@scmz.org.il
Contact: Ehud Margalioth, MD ehudMD@scmz.org.il

Locations
Israel
IVF unit, Shaare-Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Contact: Avi Tsafrir, MD    972-508573805    avits@szmc.org.il   
Principal Investigator: Avi Tsafrir, MD         
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Avi Tsafrir, MD Shaare-Zedek Medical Center, Jerusalem, Israel
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00542126     History of Changes
Other Study ID Numbers: GnRHFETsupport.CTIL
Study First Received: September 19, 2007
Last Updated: October 9, 2007
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Shaare Zedek Medical Center:
GnRH analog, IVF, infertility, frozen-thawed embryos

ClinicalTrials.gov processed this record on October 23, 2014