The purpose of the present study is to investigate the effect of heparin in the treatment of recurrent IVF– ET failure. A total of 100 infertile couple were recruited in this clinical trial. Ovarian stimulation was done by using long protocol and then on the day of embryo transfer, the patients were randomly assigned into intervention or control group. The patients in the intervention group received heparin, 5000 IU twice a day, subcutaneously, for 6 weeks but in the intervention group received no intervention. Chemical and clinical pregnancy rates were compared between groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138807202575N1
Registration date:2010-10-02, 1389/07/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-10-02, 1389/07/10
Registrant information
Name
Razieh ِDehghani Firouzabadi
Name of organization / entity
Yazd Research and Clinilcal Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 7085
Email address
dr_firouzabadi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Research and Clinical Center for Infertility and Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2009-04-22, 1388/02/02
Expected recruitment end date
2010-04-22, 1389/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of heparin in the treatment of recurrent IVF–ET Failure
Public title
Effect of heparin in the treatment of recurrent IVF–ET Failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Pervious failure of IVF cycle at least for three times, age 19-35 years old, BMI = 19- 29, FSH < 10 IU/L, good embryo quality, presence of both ovaries
Exclusion criteria: Presence of PCOS, presence of hydrosalpinx or endometriosis, presence of uterine abnormality, contraindication for heparin, presence of chronic renal, thyroid, or liver diseases, presence of thrombocytopenia
Age
From 19 years old to 35 years old
Gender
Both
Phase
1
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
Ethics Committee of Yazd Research and Clinical Center for Infertility
Street address
Bouali Ave., Safayeh, Yazd, Iran
City
Yazd
Postal code
Approval date
empty
Ethics committee reference number
1378
Health conditions studied
1
Description of health condition studied
infertility and IVF failure
ICD-10 code
N97
ICD-10 code description
female infertility
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
on day 14 after IVF
Method of measurement
BHCG
Secondary outcomes
1
Description
clinical pregnancy
Timepoint
2 weeks after positive pregnancy test
Method of measurement
detected of FHR by ultrasound
Intervention groups
1
Description
Heparin, 5000 IU, subcutaneous, twice a day, from embryo transfer to 6 weeks after delivery
Category
Treatment - Drugs
2
Description
No intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Research and Clinical Center for Infertility-Yazd-IRAN
Full name of responsible person
Mehri Mashayekhy
Street address
Bouali Ave., Safayeh, Yazd, Iran
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sodoughi Medical Science University, Yazd Research and Clinical Center for Infertility
Full name of responsible person
Mehri Mashayekhy
Street address
Bouali Ave., Safayeh, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sodoughi Medical Science University, Yazd Research and Clinical Center for Infertility
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
Yazd Research and Clinical Center for Infertility
Full name of responsible person
Mehri Mashayekhy
Position
Gynecologist
Other areas of specialty/work
Street address
Bouali Ave., Safayeh, Yazd, Iran
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
Email
Dr.Mashayekhy@gmail.com dr.mashayekhy@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Full name of responsible person
Mehri Mashayekhy
Position
Gynecologist
Other areas of specialty/work
Street address
Bouali Ave, Safayeh, Yazd, Iran.
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
Email
Dr.Mashayekhy@gmail.com dr.mashayekhy@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Full name of responsible person
Mehri Mashayekhy
Position
Gynecologist
Other areas of specialty/work
Street address
Bouali Ave., Safayeh, Yazd, Iran
City
Yazd
Postal code
Phone
Fax
Email
dr.mashayekhy@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)