Protocol summary

Summary
The aim of the present study was to explore if the injury of the endometrium increases implantation rate. In this interventional study, 100 good responders to hormone stimulation patients were assigned into intervention or control group. The intervention group underwent endometrial biopsy by biopsy catheter (piplle) on 21st day of their previous menstrual cycle with use of contraceptive pill before the IVF-ET treatment. A total of 26 patients were excluded from the study because the number of stimulated follicles was less than 3, there was no embryo, or there was the risk of OHSS. The remaining patients were 33 in the intervention and 41 in the control group. The control group received no intervention. Implantation rate was compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201008154572N1
Registration date: 2011-09-17, 1390/06/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-09-17, 1390/06/26
Registrant information
Name
Shohreh Movahedi
Name of organization / entity
Infertility center,Shariati hospital,Tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 912 300 5195
Email address
shmovahedy@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2008-06-30, 1387/04/10
Expected recruitment end date
2009-03-20, 1387/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Local injury to the endometrium does not improve the implantation rate in good responder patients undergoing in-vitro fertilization
Public title
Local injury to the endometrium does not improve the implantation rate in good responder patients undergoing in-vitro fertilization
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: infertile women aged 20- 39 years old Exclusion criteria: FSH more than 11, presence of endometriosis or hypothalamic amenorrhea, presence of azospermia in spouse
Age
From 20 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Enghelab sq- ghods st
City
Tehran
Postal code
164583583
Approval date
2011-06-11, 1390/03/21
Ethics committee reference number
90/123

Health conditions studied

1

Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
implantation rate
Timepoint
after 40 days
Method of measurement
infertility test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Endometrial biopsy by biopsy catheter (piplle) on 21st day of previous menstrual cycle with use of contraceptive pill before the IVF-ET treatment
Category
Treatment - Surgery

2

Description
Control group : No intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility Center, Shariati Hospital, Tehran University of Medical Science,
Full name of responsible person
Infertility group
Street address
Shariati Educational , Research and Healthcare Center , the beginning of Jalal Al Ahmad High way
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ale yasin
Street address
Shariati Educational, Research and Healthcare Center, the beginning of Jalal Al Ahmad High way
City
Tehran
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Shohre Movahedi M.D
Position
Infertility-author
Other areas of specialty/work
Street address
Baharloo Hospital, Tehran University of Medical Science, Iran
City
Tehran
Postal code
1645683583
Phone
+98 21556585004
Fax
+98 21 3327 2789
Email
shmovahedy@razi.tums.ac.ir
Web page address
tumspr@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Shohre Movahedi M.D
Position
Infertilitys Fellowship
Other areas of specialty/work
Street address
Baharloo Hospital, Tehran University of Medical Science, Tehran ,Iran.
City
Tehran
Postal code
Phone
00982188925071-00982188926176
Fax
+98 21 3327 2789
Email
shmovahedy@razi.tums.ac.ir- mazidmf@gmail.com
Web page address
tumspr@tums.ac.ir

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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