Effect of administration of Indomethacin , Hyoscine suppository , piroxycam capsule versus routine method before Embryo Transfer on pregnancy rates in ICSI cycles in Vali-e-Asr hospital
Although there has been great improvement in assisted reproductive techniques and in spite of transferring good quality embryos, the pregnancy rate has not changed significantly due to low implantation rates. This study was performed in order to compare the effect of administration of Indomethacin , Hyoscine suppository or Piroxycam capsule before embryo transfer on pregnancy rate in ART cycles. From Jun 2008-Jan 2011, this study was done at Vali-e-Asr Hospital on100 infertile women in ART cycles. After written consent was obtained before embryo transfer, the subjects were randomly allocated into4 groups with 25 patients in each to receive Indomethacin rectal suppository, Hyoscine rectal suppository or Piroxicam capsule and no intervention group . Primary outcome was clinical pregnancy rate and secondary outcome was feeling of lower abdominal cramp after embryo transfer.
General information
Acronym
Effect of administration of Indomethacin , Hyoscine suppository and piroxyc
IRCT registration information
IRCT registration number:IRCT138807252565N3
Registration date:2012-08-16, 1391/05/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-16, 1391/05/26
Registrant information
Name
Farnaz Sohrabvand
Name of organization / entity
Vali-E _Asr Reproductive Health Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 9320
Email address
sohrabva@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2008-06-30, 1387/04/10
Expected recruitment end date
2011-01-01, 1389/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of administration of Indomethacin , Hyoscine suppository , piroxycam capsule versus routine method before Embryo Transfer on pregnancy rates in ICSI cycles in Vali-e-Asr hospital
Public title
Assessment of Indomethacin , Hyoscine and Piroxycam administration effect before embryo transfer versus routine method on ART outcome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 20-35 years, normal response to induction of ovulation
Exclusion criteria: history of medical illnesses, endometriosis.
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research, Tehran University of Medical Sciences
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Ghods Street
City
Tehran
Postal code
14194
Approval date
2007-03-23, 1386/01/03
Ethics committee reference number
1878
Health conditions studied
1
Description of health condition studied
Noninflammatory disorders of female genital tract
ICD-10 code
N98.3
ICD-10 code description
Complications of attempted introduction of embryo in embryo transfer
Primary outcomes
1
Description
clinical pregnancy rate
Timepoint
4 weeks after ET
Method of measurement
Sonography and blood Test (B-HcG)
Secondary outcomes
1
Description
lower abdominal cramp
Timepoint
After ET
Method of measurement
according to patient complaints
Intervention groups
1
Description
Intervention group A:rectal indomethacin 10 mg suppository 30 minutes befror embryo transfer
Category
Treatment - Drugs
2
Description
Control group: no intervention before embryo transfer ( routine procidure)
Category
Treatment - Drugs
3
Description
Intervention group B:rectal Hyoscine 100 mg suppository 30 minutes before embryo transfer
Category
Treatment - Drugs
4
Description
Intervention group C:oral l Piroxicam capsule 10 mg 30 minutes before embryo transfer
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali_e-Asr reproductive health research center,infertility Ward
Full name of responsible person
Dr.Farnaz Sohrabvand
Street address
Imam khomeini Hospital, Vali-E-Asr Reproductive health Resaerch Center
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Resaerch Deputy of Tehran Medical Sciences
Full name of responsible person
Dr.Rezaie
Street address
Ghods Street ,Tehran medical university
City
Tehran
Grant name
Grant code / Reference number
1878
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Resaerch Deputy of Tehran 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
Vali-e-asr reproductive health research center
Full name of responsible person
Fedyeh Haghollahi
Position
Research Expert
Other areas of specialty/work
Street address
Imam Khomeini Hospital ,Vali-E-Asr Hospital
City
Tehran
Postal code
14194
Phone
+98 21 6693 9320
Fax
+98 21 6658 1658
Email
fedyeh_hagh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Vali-e-asr Reproductive Health Research Center
Full name of responsible person
Dr.Farnaz Sohrabvand
Position
Associate professor OB,GYN&INF.Laparascopy
Other areas of specialty/work
Street address
Imam Khomeini hospital, Vali-E-Asr Hospital
City
Tehran
Postal code
14194
Phone
+98 21 6693 9320
Fax
+98 21 6658 1658
Email
fsohrabvand@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Vali-E-Asr Reproductive Health reasearch Center
Full name of responsible person
Fedyeh Haghollahi
Position
Expert Research
Other areas of specialty/work
Street address
Imam Khomeini Hospital,Vali-E-Asr Reproductive Health research center
City
Tehran
Postal code
14194
Phone
+98 21 6693 9320
Fax
+98 21 6658 1658
Email
fedyeh_hagh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)