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

This study has suspended participant recruitment.

(no patient was recruited till 1/2008)

Sponsor:

Information provided by:

Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT00345306

First received: June 27, 2006

Last updated: May 6, 2008

Last verified: June 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

June 27, 2006

Last Updated Date

May 6, 2008

Start Date ^ICMJE

March 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Pregnancy rates

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00345306 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Lutheal hormonal profile

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan - a Clinical Comparative Study

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Frozen Thawed Embryo Transfer

Intervention ^ICMJE

Drug: Comparison between two different progesterone administration

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

120

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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 -

Gender

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00345306

Other Study ID Numbers ^ICMJE

EndoUtro-HMO-CTIL

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Hadassah Medical Organization

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Alex Simon

Hadassah University Hospital

Information Provided By

Hadassah Medical Organization

Verification Date

June 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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