NCT00837733

Brief Summary

The purpose of this study is to evaluate the influence of endometrial biopsy on increasing implantation rate in patients with recurrent implantation failures, 93 women with at least two implantation failures were evaluated. In case group endometrial biopsy was obtained from 48 patients in the luteal phase of previous cycle and implantation and clinical pregnancy rate were compared with 45 patients in control group. The results suggest that in vitro fertilization or intracytoplasmic sperm injection after endometrial biopsy increase pregnancy outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

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

January 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2009

Completed
Last Updated

February 5, 2009

Status Verified

February 1, 2009

Enrollment Period

10 months

First QC Date

February 4, 2009

Last Update Submit

February 4, 2009

Conditions

Infertility

Keywords

Endometrial biopsyIVF/ICSIPregnancy outcomeRecurrent implantation failure

Outcome Measures

Primary Outcomes (1)

  • Implantation Rate,Chemical pregnancy rate, Clinical pregnancy rate

    One year

Study Arms (1)

Biopsy catheter

EXPERIMENTAL

Biopsy catheter (Pipelle de Cornier, Prodimed, Neuilly-en-Thelle, France

Procedure: Endometrial biopsy

Interventions

Endometrial BiopsyPROCEDURE

Endometrial biopsy was done at luteal phase on the day 21-26 of spontaneous menstrual cycles, when GnRH agonist uses begun. Endometrial samples were taken by a biopsy catheter

Also known as: biopsy catheter (Pipelle de Cornier, Prodimed, France
Biopsy catheter

Eligibility Criteria

Age15 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • women with recurrent implantation failure which was defined as 2-6 cycles unsuccessful of IVF-ET in which more than 10 high grade embryo were transferred

You may not qualify if:

  • age over than 40 years old
  • poor responders to ovarian stimulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research and Clinical Center for Infertility

Yazd, Yazd Province, 8916877391, Iran

Location

Related Publications (1)

  • Lensen SF, Armstrong S, Gibreel A, Nastri CO, Raine-Fenning N, Martins WP. Endometrial injury in women undergoing in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Jun 10;6(6):CD009517. doi: 10.1002/14651858.CD009517.pub4.

    PMID: 34110001DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Mohammad Ali Karimzadeh, Professor

    Research and Clinical Center for Infertility

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 5, 2009

Study Start

January 1, 2008

Primary Completion

November 1, 2008

Study Completion

December 1, 2008

Last Updated

February 5, 2009

Record last verified: 2009-02

Locations

IR(1)