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Effect of Local Injury on Implantation

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ClinicalTrials.gov Identifier: NCT00846183
Recruitment Status : Completed
First Posted : February 18, 2009
Last Update Posted : December 23, 2013
Sponsor:
Information provided by (Responsible Party):
homa oskouian, Yazd Research & Clinical Center for Infertility

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.

Condition or disease Intervention/treatment Phase
Implantation Rate Procedure: local injury Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
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.
Study Start Date : June 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : June 2009

Arm Intervention/treatment
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



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

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


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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

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

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 Posted: February 18, 2009    Key Record Dates
Last Update Posted: December 23, 2013
Last Verified: December 2013

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