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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
  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 4

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:

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:

  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 -
  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:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Progesterone
 Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013