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Effect of Local Injury on Implantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00846183
First Posted: February 18, 2009
Last Update Posted: December 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
homa oskouian, Yazd Research & Clinical Center for Infertility
  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
Intervention Model: Parallel Assignment
Masking: None (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.

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

Primary Outcome Measures:
  • implantation rate [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • clinical pregnancy rate [ Time Frame: 4 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: homa oskouian, fellowship, Yazd Research & Clinical Center for Infertility
ClinicalTrials.gov Identifier: NCT00846183     History of Changes
Other Study ID Numbers: local injury111
First Submitted: February 17, 2009
First Posted: February 18, 2009
Last Update Posted: December 24, 2013
Last Verified: December 2013

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