Our aim in this study is to evaluate the role of heparin in embryo implantation of women with recurrent implantation failure in ART cycles. In a randomized unicentral clinical trial, 40 infertile 18 to 40 year-old females with a history of at least two failures in ART cycles who are reffering to infertility clinic of Alzahra hospital will be involved. After stimulation of ovulation and initiation of therapeutic cycle patients who have recieved the oocyte will be divided into two equal-sized case or control groups to recieve subcutaneous heparin 5000 units daily for 15 days in case group or not to recieve any anti-coagulat therapy in control group. In day 15th a pregnancy test (serum Beta-HCG) will be checked for each patient to evaluate the status. Key inclusion criteria would be to have a history of at least two well-grade embryo implantation failures; to be under 40 years old; not to have coagulopathy or any hormonal, imunologic disorder of any kind and the key exclusion criteria would be clear evidence of implantation failure such as hydrosalpinx, submucusal myomas, lack of well-graded embryos to be transferred.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203146868N2
Registration date:2012-04-18, 1391/01/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-18, 1391/01/30
Registrant information
Name
Mahzad Sadaghiani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
sadaghianim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-02-29, 1390/12/10
Expected recruitment end date
2012-08-31, 1391/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of Heparin in embryo implantation of women with recurrent implantation failure in ART cycles
Public title
Does heparin affect embryo implantation?
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (to have a history of at least two well-grade embryo implantation failures; to be under 40 years old; not to have coagulopathy or any hormonal, imunologic disorder of any kind; to have normal uterine lumen)
Exclusion criteria: (women who have a medical condition which needs to be treated with anti-coagulants; clear evidence of implantation failure such as hydrosalpinx, submucusal myomas, lack of well-graded, A and B, embryos to be transferred)
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz Medical University
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah square
City
Tabriz
Postal code
Approval date
2012-01-28, 1390/11/08
Ethics committee reference number
5/4/8672
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
15 days after recieving the ovoola
Method of measurement
Blood beta-HCG level
Secondary outcomes
empty
Intervention groups
1
Description
for case group: Subcutaneous heparin 5000 units daily for 15 days from the day of recieving ovoola
Category
Treatment - Drugs
2
Description
For control group: no anticoagulants.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility clinic of Alzahra hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Allahverdi Chalabizadeh
Position
Intern
Other areas of specialty/work
Street address
Faculty of medicine, Golgasht st.
City
Tabriz
Postal code
Phone
+98 41 1658 4153
Fax
Email
a.chalabizadeh60@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehrzad Sadaghiani
Position
Gynecologist, associate professor
Other areas of specialty/work
Street address
Alzahra hospital, Baghshomal square
City
Tabiz
Postal code
Phone
+98 41 1658 4153
Fax
Email
sadaghianim@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Allahverdi Chalabizadeh
Position
Itern
Other areas of specialty/work
Street address
Faculty of medicine, Golgasht st.
City
Tabriz
Postal code
Phone
+98 41 1658 4153
Fax
Email
a.chalabizadeh60@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)