NCT01778452

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

2.9 years

First QC Date

January 25, 2013

Last Update Submit

February 14, 2013

Conditions

Genomic Human Endometrial Expression Profile

Keywords

Endometrial priming, genomic expression. Natural cycle. Antagonist GnRH.

Outcome Measures

Primary Outcomes (1)

  • genetic endometrial human profile expression

    implantation related genes profile expression

    Oocyte donors will be followed up for four to six months

Study Arms (3)

Natural cycle

ACTIVE COMPARATOR

Natural cycle endometrial biopsy, lh+7

Procedure: endometrial biopsy

Antagonist cycle + endometrial priming.

EXPERIMENTAL

Antagonist cycle + endometrial priming for egg donation program. endometrial biopsy, p4+5

Procedure: endometrial biopsy

Agonist cycle + endometrial priming.

EXPERIMENTAL

Agonist cycle + endometrial priming for egg donation program endometrial biopsy, p4+5

Procedure: endometrial biopsy

Interventions

endometrial biopsyPROCEDURE

endometrial biopsy

Agonist cycle + endometrial priming.Antagonist cycle + endometrial priming.Natural cycle

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • egg healthy volunteer egg donors.
  • Volunteers.
  • years old
  • Healthy.
  • BMI \<28.

You may not qualify if:

  • \- BMI \> 28
  • Smokers-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ivi Valencia

Valencia, Valencia, 46015, Spain

Location

Study Officials

  • Carmen Vidal, MDphD

    IVI Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2013

First Posted

January 29, 2013

Study Start

November 1, 2009

Primary Completion

October 1, 2012

Study Completion

January 1, 2013

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

ES(1)