NCT00436462

Brief Summary

Expression of steroid receptors in endometrium during ovarian stimulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2005

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

December 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 19, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

November 9, 2009

Status Verified

November 1, 2009

Enrollment Period

2 years

First QC Date

February 16, 2007

Last Update Submit

November 6, 2009

Conditions

Endometrium

Keywords

Steroid receptorsEndometriumIVFFollicular phase

Outcome Measures

Primary Outcomes (1)

  • Steroid receptors expression in endometrium during early follicular phase

    3 months

Secondary Outcomes (1)

  • In which day:day o+2, day 0+4 or day HCG

    1 month

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

infertile women

You may qualify if:

  • Treatment by IUI,
  • BMI:18-29KGR/M2,
  • No previous ovarian surgery,
  • Normal hysterosalpingography,
  • Estradiol \< 80pg/ml and progesterone \< 1.6ng/ml on day 2 of the cycle

You may not qualify if:

  • Endometriosis,
  • Severe male factor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit of Human Reproduction, 1st Department of Obstetrics & Gynecology, AUTH, Papageorgiou Hospital

Thessaloniki, 56429, Greece

Location

Related Publications (2)

  • Kolibianakis E, Bourgain C, Albano C, Osmanagaoglu K, Smitz J, Van Steirteghem A, Devroey P. Effect of ovarian stimulation with recombinant follicle-stimulating hormone, gonadotropin releasing hormone antagonists, and human chorionic gonadotropin on endometrial maturation on the day of oocyte pick-up. Fertil Steril. 2002 Nov;78(5):1025-9. doi: 10.1016/s0015-0282(02)03323-x.

    PMID: 12413988BACKGROUND

  • Papanikolaou EG, Bourgain C, Kolibianakis E, Tournaye H, Devroey P. Steroid receptor expression in late follicular phase endometrium in GnRH antagonist IVF cycles is already altered, indicating initiation of early luteal phase transformation in the absence of secretory changes. Hum Reprod. 2005 Jun;20(6):1541-7. doi: 10.1093/humrep/deh793. Epub 2005 Feb 10.

    PMID: 15705618BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

endometrial tissue

Study Officials

  • Basil C Tarlatzis, MD,PhD

    Unit of Human Reproduction, 1st Department of Obst & Gyn, Aristotle University of Thessaloniki, Papageorgiou Hospital, Greece

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 16, 2007

First Posted

February 19, 2007

Study Start

December 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

November 9, 2009

Record last verified: 2009-11

Locations

GR(1)