Endometrial Genomic Profile in Endometrial Priming

February 14, 2013 updated by: Instituto Valenciano de Infertilidad, IVI VALENCIA

Profile Study of Genomics Endometrial Expression After Gonadotropin-releasing Hormone Agonist Administration and GnRH in Endometrial Priming.

The aim of this study is to analyse genomics profile expression in endometrium under different endometrial priming for recipients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We analyze the genomic profile of egg donors in different endometrial priming protocols, compared with natural cycle, including the conventional single long acting GnRH agonist injection in the mid luteal phase of the previous cycle of the endometrial priming and the single daily antagonist injection (Cetrorelix 0.25 mg) administered in the early follicular phase followed by endometrial priming. Endometrial biopsy will be taken in luteinizing hormone

  • 7 or with P4 +5 in cases with endometrial priming with oestrogens therapy.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

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
      • Valencia, Spain, 46015
        • IVI Valencia

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 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 6 egg healthy volunteer egg donors.
  • Volunteers.
  • 18-35 years old
  • Healthy.
  • BMI <28.

Exclusion Criteria:

  • - BMI > 28
  • Smokers-

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Natural cycle
Natural cycle endometrial biopsy, lh+7
Procedure: endometrial biopsy
endometrial biopsy
Experimental: Antagonist cycle + endometrial priming.
Antagonist cycle + endometrial priming for egg donation program. endometrial biopsy, p4+5
Procedure: endometrial biopsy
endometrial biopsy
Experimental: Agonist cycle + endometrial priming.
Agonist cycle + endometrial priming for egg donation program endometrial biopsy, p4+5
Procedure: endometrial biopsy
endometrial biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
genetic endometrial human profile expression
Time Frame: Oocyte donors will be followed up for four to six months
implantation related genes profile expression
Oocyte donors will be followed up for four to six months

Collaborators and Investigators

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

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Collaborators

Igenomix

Investigators

  • Principal Investigator: Carmen Vidal, MDphD, IVI Valencia

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

November 1, 2009

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

January 25, 2013

First Submitted That Met QC Criteria

January 28, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 14, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VLC18012013

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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