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

NCT ID: NCT00345306

Last Updated: 2008-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Frozen Thawed Embryo Transfer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Comparison between two different progesterone administration

Intervention Type DRUG

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Principal Investigators

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Alex Simon

Role: PRINCIPAL_INVESTIGATOR

Hadassah University Hospital

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Simon Alex

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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EndoUtro-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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