NCT00846183

Brief Summary

Local injury on two sights of endometrium are performed in 60 patients in their first IVF cycle and implantation rate are compared with fresh cycles without local injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_2

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

June 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

December 23, 2013

Status Verified

December 1, 2013

Enrollment Period

5 months

First QC Date

February 17, 2009

Last Update Submit

December 20, 2013

Conditions

Implantation Rate

Keywords

local injuryimplantation rateendometrial receptivityIVF

Outcome Measures

Primary Outcomes (1)

  • implantation rate

    4 weeks

Secondary Outcomes (1)

  • clinical pregnancy rate

    4 weeks

Study Arms (2)

local ingury

ACTIVE COMPARATOR

In one group, on the day of oocyte retrieval, local injury to endometrium with a Novak curet to anterior and posterior wall of endometrium are performed.

Procedure: local injury

control

NO INTERVENTION

in 60 patients routine IVF are performed

Interventions

local injuryPROCEDURE

In one group, on the day of oocyte retrieval, local injury to endometrium with a Novak curet to anterior and posterior wall of endometrium are performed

Also known as: it does not have other name
local ingury

Eligibility Criteria

AgeUp to 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age \< 35
  • First IVF cycle
  • Long protocol should be used for stimulation

You may not qualify if:

  • Day 3 FSH \> 10

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research and clinical center for infertility

Yazd, Yazd Province, 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

Study Officials

  • homa oskouian, M.D.

    Research and clinical center for infertility

    PRINCIPAL INVESTIGATOR

  • Mohamad ali karimzade, MD

    Research and clinical center for infertility

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
fellowship

Study Record Dates

First Submitted

February 17, 2009

First Posted

February 18, 2009

Study Start

June 1, 2008

Primary Completion

November 1, 2008

Study Completion

June 1, 2009

Last Updated

December 23, 2013

Record last verified: 2013-12

Locations

IR(1)