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

This study has been suspended.

( no patient was recruited till 1/2008 )

First Received on June 27, 2006. Last Updated on May 6, 2008 History of Changes

Sponsor:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00345306

Purpose

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	Intervention	Phase
Frozen Thawed Embryo Transfer	Drug: Comparison between two different progesterone administration	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan - a Clinical Comparative Study

Resource links provided by NLM:

Drug Information available for: Progesterone

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

Pregnancy rates

Secondary Outcome Measures:

Lutheal hormonal profile

Estimated Enrollment:	120
Study Start Date:	March 2007

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female

Criteria

Inclusion Criteria:

Patients undergoing frozen thawed ET cycles
Patient has at least two embryos suitable for transfer after thawing
Age 18-35 years -

Exclusion Criteria:

Any known sensitivity to Endometrin or Utrogestan
Endometrial thickness less than 7.5 mm after estrogen priming -

Contacts and Locations

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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00345306 History of Changes
Other Study ID Numbers:	EndoUtro-HMO-CTIL
Study First Received:	June 27, 2006
Last Updated:	May 6, 2008
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012