Text Size

Endometrial Genomic Profile in Endometrial Priming

This study has been completed.
Sponsor:
Collaborator:
Iviomics
Information provided by (Responsible Party):
Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01778452
First received: January 25, 2013
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention
Genomic Human Endometrial Expression Profile
 Procedure: endometrial biopsy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • genetic endometrial human profile expression [ Time Frame: Oocyte donors will be followed up for four to six months ] [ Designated as safety issue: Yes ]
    implantation related genes profile expression


Enrollment: 6
Study Start Date: November 2009
Study Completion Date: January 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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-
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778452

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

No publications provided

Responsible Party: Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier: NCT01778452     History of Changes
Other Study ID Numbers: VLC18012013
Study First Received: January 25, 2013
Last Updated: February 14, 2013
Health Authority: Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 21, 2013