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Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan

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ClinicalTrials.gov Identifier: NCT00345306
Recruitment Status : Suspended (no patient was recruited till 1/2008)
First Posted : June 28, 2006
Last Update Posted : May 7, 2008
Sponsor:
Information provided by:
Hadassah Medical Organization

Brief 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.

Condition or disease Intervention/treatment Phase
Frozen Thawed Embryo Transfer Drug: Comparison between two different progesterone administration Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan - a Clinical Comparative Study
Study Start Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Pregnancy rates

Secondary Outcome Measures :
  1. Lutheal hormonal profile


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   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 -

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 ClinicalTrials.gov identifier (NCT number): NCT00345306


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Simon Alex
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Alex Simon Hadassah University Hospital

ClinicalTrials.gov Identifier: NCT00345306     History of Changes
Other Study ID Numbers: EndoUtro-HMO-CTIL
First Posted: June 28, 2006    Key Record Dates
Last Update Posted: May 7, 2008
Last Verified: June 2006

Keywords provided by Hadassah Medical Organization:
endometrial preparation
Utrogestan
Endometrin

Additional relevant MeSH terms:
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs