The transfer of frozen-thawed embryos can be performed in a natural ovulatory cycle or in a hormonally manipulated cycle with a comparable pregnancy rate of 15%-20% per ET. When a hormonally modulated ET cycle is scheduled,an artificial endometrial preparation is carried out using estrogen stimulation followed by a concomitant progesterone treatment. Two progestative drugs are currently used in...
Date First Received: June 27, 2006
Last Updated: May 6, 2008
Verified by: Hadassah Medical Organization, June 2006
Clinical Trial Phase: Phase 4 | Start Date: March 2007
Overall Status: Suspended
Estimated Enrollment: 120
Brief Summary
Official Title: “Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan - a Clinical Comparative Study”
Condition Keyword(s):
Intervention(s):
The transfer of frozen-thawed embryos can be performed in a natural ovulatory cycle or in a hormonally manipulated cycle with a comparable pregnancy rate of 15%-20% per ET. When a hormonally modulated ET cycle is scheduled,an artificial endometrial preparation is carried out using estrogen stimulation followed by a concomitant progesterone treatment. Two progestative drugs are currently used in conventional IVF treatment, Utrogetan and Endometrin. Although Endometrin has been be efficiently used to support the luteal phase after embryo transfer in IVF cycles, currently, there is no study that assess its efficacy for clinical use in frozen-thawed ET cycles. The present study aims to compare the outcome of frozen thawed ET cycles when either Endometrin or Utrogestan are used as the progestative substitution in an artificially prepared endometrium.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Comparison between two different progesterone administration
Outcome Measures for this Clinical Trial
Primary Measures
- Pregnancy rates
Secondary Measures
- Lutheal hormonal profile
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 1. Patients undergoing frozen thawed ET cycles
- 2. Patient has at least two embryos suitable for transfer after thawing
- 3. Age 18-35 years -
Exclusion Criteria:
- 1. Any known sensitivity to Endometrin or Utrogestan
- 2. Endometrial thickness less than 7.5 mm after estrogen priming -
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 35 Years
Clinical Trial Sponsor Information
Lead Sponsor: Hadassah Medical Organization
Overall Clinical Trial Officials and Contacts
Alex Simon Principal Investigator Hadassah University Hospital
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00345306
Study ID Number: EndoUtro-HMO-CTIL
ClinicalTrials.gov Identifier: NCT00345306
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
Clinical Trials Authorship and Review
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