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Endometrial Genomic Profile in Endometrial Priming

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ClinicalTrials.gov Identifier: NCT01778452
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : February 15, 2013
Sponsor:
Collaborator:
Igenomix
Information provided by (Responsible Party):
Instituto Valenciano de Infertilidad, IVI VALENCIA

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

Condition or disease Intervention/treatment Phase
Genomic Human Endometrial Expression Profile Procedure: endometrial biopsy Not Applicable

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  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Profile Study of Genomics Endometrial Expression After Gonadotropin-releasing Hormone Agonist Administration and GnRH in Endometrial Priming.
Study Start Date : November 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

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



Primary Outcome Measures :
  1. genetic endometrial human profile expression [ Time Frame: Oocyte donors will be followed up for four to six months ]
    implantation related genes profile expression



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • - BMI > 28
  • Smokers-

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778452


Locations
Spain
Ivi Valencia
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
Igenomix
Investigators
Principal Investigator: Carmen Vidal, MDphD IVI Valencia

Responsible Party: Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier: NCT01778452     History of Changes
Other Study ID Numbers: VLC18012013
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013

Keywords provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:
Endometrial priming, genomic expression. Natural cycle. Antagonist GnRH.