Effect of Local Injury on Implantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
homa oskouian, Yazd Research & Clinical Center for Infertility
ClinicalTrials.gov Identifier:
NCT00846183
First received: February 17, 2009
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Implantation Rate
Procedure: local injury
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Local Injury to Endometrium on the Day of Oocyte Retrieval in First IVF Cycle on Implantation Rate.

Resource links provided by NLM:


Further study details as provided by Yazd Research & Clinical Center for Infertility:

Primary Outcome Measures:
  • implantation rate [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • clinical pregnancy rate [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 156
Study Start Date: June 2008
Study Completion Date: June 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: local ingury
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
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
Other Name: it does not have other name
No Intervention: control
in 60 patients routine IVF are performed

Detailed Description:

Low implantation rate is still a major concern in ART cycles. It has been reported that local injury to endometrium may improve endometrial receptivity and implantation rate. A total of 120 patients in first IVF cycles, who are stimulated with long protocol, are randomly divided into two groups. 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 and in the other group no interventions are done. After fresh embryo transfers, implantation and clinical pregnancy rates are compared between two groups.

  Eligibility

Ages Eligible for Study:   up to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Day 3 FSH > 10
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00846183

Locations
Iran, Islamic Republic of
Research and clinical center for infertility
Yazd, Iran, Islamic Republic of
Sponsors and Collaborators
Yazd Research & Clinical Center for Infertility
Investigators
Principal Investigator: homa oskouian, M.D. Research and clinical center for infertility
Principal Investigator: Mohamad ali karimzade, MD Research and clinical center for infertility
  More Information

No publications provided

Responsible Party: homa oskouian, fellowship, Yazd Research & Clinical Center for Infertility
ClinicalTrials.gov Identifier: NCT00846183     History of Changes
Other Study ID Numbers: local injury111
Study First Received: February 17, 2009
Last Updated: December 20, 2013
Health Authority: Iran: Ministry of Health

Keywords provided by Yazd Research & Clinical Center for Infertility:
local injury
implantation rate
endometrial receptivity
IVF

ClinicalTrials.gov processed this record on October 29, 2014