NCT01472861

Brief Summary

The purpose of this study is to determine if the use of Autologous Endometrial Coculture (AECC) in young in vitro fertilization (IVF) patients with poor ovarian reserve improves pregnancy outcome.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2009

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

4.7 years

First QC Date

November 11, 2011

Last Update Submit

June 10, 2015

Conditions

Infertility

Keywords

cocultureendometrial biopsyIVF poor responders

Outcome Measures

Primary Outcomes (1)

  • Pregnancy outcome

    1 month

Secondary Outcomes (1)

  • Embryo quality

    1 month

Study Arms (2)

No AECC

PLACEBO COMPARATOR

Routine procedures without AECC

Other: no endometrial biopsy or Autologous endometrial coculture (AECC) performed

AECC

EXPERIMENTAL

Endometrial biopsy and Autologous endometrial coculture

Procedure: AECC (Autologous endometrial coculture)

Interventions

AECC (Autologous endometrial coculture)PROCEDURE

endometrial biopsy with autologous endometrial coculture

AECC
no endometrial biopsy or Autologous endometrial coculture (AECC) performedOTHER

routine procedures with out biopsy

No AECC

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women undergoing IVF at CRMI
  • Age ≤ 38 years
  • Poor ovarian reserve with antral follicle count less than 6 follicles, cycle day 2/3 FSH \> 12 ng/ml, AMH \< 0.5 ng/ml

You may not qualify if:

  • Healthy women undergoing IVF with male factor, severe endometriosis, or tubal factor infertility
  • Donor patients
  • Contraindications for the use of gonadotropins (i.e. pregnancy, lactation, undiagnosed vaginal bleeding or ovarian cysts)
  • Recent or current medical conditions where the patient is not medically stable to undergo stimulation or egg retrieval, HIV infection, diabetes, cardiovascular disease, gastrointestinal, hepatic disease, renal or pulmonary disease.
  • Any patient who is not a candidate for IVF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Reproducutve Medicine; Weill Cornell Medical College

New York, New York, 10021, United States

Location

Related Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Spandorfer Steven, MD

    Weill Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2011

First Posted

November 17, 2011

Study Start

October 1, 2009

Primary Completion

June 1, 2014

Study Completion

June 1, 2015

Last Updated

June 12, 2015

Record last verified: 2015-06

Locations

US(1)