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

Pregnancy Rate Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00542126
• Other study ID #: GnRHFETsupport.CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: September 19, 2007
• Last updated: October 9, 2007
• Start date: December 2007
• Est. completion date: September 2009

Study information

• Verified date: September 2007
• Source: Shaare Zedek Medical Center
• Contact: Avi Tsafrir, MD
• Phone: 972-508573805
• Email: avits[@]scmz.org.il
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Est. completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pregnancy Rate

Intervention

Drug:
• Decapeptyl 0.1 mg after embryo transfer
Decapeptyl 0.1 mg (Ferring, Kiel, Germany) 3 days following embryo transfer

Locations

Country	Name	City	State
Israel	IVF unit, Shaare-Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

References & 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. Epub 2006 Aug 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy and delivery rates