Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan
Information source: Hadassah Medical Organization
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Frozen Thawed Embryo Transfer
Intervention: Comparison between two different progesterone administration (Drug)
Phase: Phase 4
Status: Suspended
Sponsored by: Hadassah Medical Organization Official(s) and/or principal investigator(s):
Alex Simon, Principal Investigator, Affiliation: Hadassah University Hospital
Summary
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.
Clinical Details
Official title: Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan - a Clinical Comparative Study
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Pregnancy rates
Secondary outcome: Lutheal hormonal profile
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
Criteria:
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 -
Locations and Contacts
Hadassah Medical Organization, Jerusalem 91120, Israel
Simon Alex, Jerusalem 91120, Israel
Additional Information
Starting date: March 2007
Last updated: May 6, 2008
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