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

Frozen Thawed Embryo Transfer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00345306
• Other study ID #: EndoUtro-HMO-CTIL
• Status: Suspended
• Phase: Phase 4
• First received: June 27, 2006
• Last updated: May 6, 2008
• Start date: March 2007

Study information

• Verified date: June 2006
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 120
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 -

Study Design

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

Related Conditions & MeSH terms

• Frozen Thawed Embryo Transfer

Intervention

Drug:
• Comparison between two different progesterone administration

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem
Israel	Simon Alex	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rates
Secondary	Lutheal hormonal profile