Endometrial Priming for Embryo Transfer

NCT ID: NCT01430650

Last Updated: 2017-09-20

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2015-07-31

Brief Summary

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The aim of this trial is compare two different endometrial priming protocols

* women that receive oral estrogens
* women that receive transdermal estrogens

Detailed Description

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Conditions

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Sterility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral strogen

Group Type EXPERIMENTAL

Oral strogen

Intervention Type DRUG

2 mg of estradiol every day beginning the second day of the cycle until day 7. 4 mg of estradiol every day beginning 8th day of the cycle until day 10. 6 mg of estradiol every day beginning 11th day of the cycle until day 16.

Transdermal strogen

Group Type EXPERIMENTAL

Transdermal strogen

Intervention Type DRUG

One patch of 75 mcg of estradiol hemimydrate every 48 h from 2 to day 6. Two patches of 75 mcg of estradiol hemimydrate every 48 h from 6 to day 12. Three patches of 75 mcg of estradiol hemimydrate every 48 h from 12 to day 16.

Interventions

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Oral strogen

2 mg of estradiol every day beginning the second day of the cycle until day 7. 4 mg of estradiol every day beginning 8th day of the cycle until day 10. 6 mg of estradiol every day beginning 11th day of the cycle until day 16.

Intervention Type DRUG

Transdermal strogen

One patch of 75 mcg of estradiol hemimydrate every 48 h from 2 to day 6. Two patches of 75 mcg of estradiol hemimydrate every 48 h from 6 to day 12. Three patches of 75 mcg of estradiol hemimydrate every 48 h from 12 to day 16.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women between 18-50 years old with desire of children and needs of embryo transfer.
* Plasma prolactin less than 30.
* Uterine cavity that allow pregnancy, body mass index between 20-30.
* And signed consent inform.

Exclusion Criteria

* History of estrogen dependent cancer, unknown origin vaginal bleeding.
* Ovarian cyst.
* Contraindications to be pregnant.
* Estrogen allergy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Parc de Salut Mar

OTHER

Sponsor Role lead

Responsible Party

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Miguel Angel Checa

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital del Mar

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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UREP-PREPENDO-2010

Identifier Type: -

Identifier Source: org_study_id