The aim of this study is Evaluation of Vaginal Misoprostol Effect on Pregnancy Rate after IuI in Al-Zahra hospital- Rasht. This study will be performed on 210 women (2011-2012) in Rasht, Al-Zahra hospital, After written and informed consent to participate in the survey. The women randomly will be divided into two groups of 105 persons. One group (Intervention group) will be given 200 Mg Vaginal Misoprostol after IuI and the other group (control group) will be given placebo. Any person who involved as executive agents in this study has no information about prescribed drugs. Then, Pregnancy Rate in both groups will be collected and compared. And also, the other factor such as age- kind's infertility- time of infertility- Ethiology of infertility- sperm count- sperm motility and number of dominant folliculs and their effect on Pregnancy Rate in both groups will be compared by using statistical methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206191306N5
Registration date:2012-10-15, 1391/07/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-15, 1391/07/24
Registrant information
Name
Ziba Zahiri
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
drzibazahiri@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research – Guilan university of medical sciences
Expected recruitment start date
2012-09-05, 1391/06/15
Expected recruitment end date
2013-03-21, 1392/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of vaginal Misoprostol Effect on pregnancy Rate after IUI
Public title
Evaluation of vaginal Misoprostol Effect on pregnancy Rate after IUI
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria: patient with infertilitie's etioligy: 1-Male Factor, 2-Onovulatory Factor, that not yet fertile, despite use of Induction Ovulation and production Dominant follicule, 3-Idiopathic infertility, 4-The other reasons such as problems in Intercourse.
The exclusion criteria: Other reasons of infertility
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
210
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for research – Guilan university of medical sciences
Street address
Vice Chancellor for research – Guilan university of medical sciences, Namjoo street
City
Rasht
Postal code
Approval date
2012-09-01, 1391/06/11
Ethics committee reference number
1910182904
Health conditions studied
1
Description of health condition studied
Pregnancy, childbirth and the puerperium
ICD-10 code
O94
ICD-10 code description
Sequelae of complication of pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Pregnancy rate
Timepoint
2 weeks after IUI
Method of measurement
Pregnancy test
Secondary outcomes
empty
Intervention groups
1
Description
Prescription of 200 microgram of Vaginal Misoprostol to intervention group
Category
Treatment - Drugs
2
Description
Prescription of Vaginal Placebo to control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
AL_Zahra Hospital
Full name of responsible person
Dr Ziba Zahiri
Street address
Reproductive health research Center, Al_Zahra Hospital, Namjoo Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research – Guilan university of medical sciences
Full name of responsible person
Dr Abdol Rasol Sobhani
Street address
Vice Chancellor for research – Guilan university of medical sciences, Namjoo street
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research – Guilan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Al_Zahra Hospital, Reproductive Health Research Center
Full name of responsible person
Dr Ziba Zahiri
Position
Associated professor Gilan University of Medical Science
Other areas of specialty/work
Street address
Reproductive Health Research Center, Al_Zahra Hospital, Namjoo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
drzibazahiri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Reproductive Health Research Center
Full name of responsible person
seyedeh maryam mosavi chahardeh
Position
B.S. midwife
Other areas of specialty/work
Street address
Reproductive Health Research Center,Al_Zahra Hospital, Namjoo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
maryammosavi1363@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)