Endometrial Priming for Embryo Transfer

September 19, 2017 updated by: Miguel Angel Checa, Parc de Salut Mar

A Randomised Control Trial to Evaluate Efficacy and Safety of Two Different Protocols of Endometrial Priming for Embryo Transfer.

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

  • women that receive oral estrogens
  • women that receive transdermal estrogens

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral strogen
Drug: 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.
Experimental: Transdermal strogen
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference between day means in endometrial priming to achieve 7 mm.
Time Frame: 11-16 days
11-16 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical Pregnancy rate
Time Frame: 26-30 days
To calculate the biochemical pregnancy rate, we will divide the number of biochemical pregnancy into the number of embryonary transference and multiply by 100.
26-30 days
The patient's adherence to the recommended treatment.
Time Frame: 1-16 days
1-16 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

June 20, 2011

First Submitted That Met QC Criteria

September 7, 2011

First Posted (Estimate)

September 8, 2011

Study Record Updates

Last Update Posted (Actual)

September 20, 2017

Last Update Submitted That Met QC Criteria

September 19, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UREP-PREPENDO-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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