Objectives: To assess the effect intra-uterine hCG injection versus placebo in improving implantation in women fertilized with IVF method.
Design: a randomized clinical trial.
Setting and conduct: The eligible women fertilized with IVF method who will refer to Fatemieh Hospital during the study period will be enrolled into the trial.
Inclusion criteria: age of 18 to 40 years; the cause of infertility is male sex.
Exclusion criteria: using OCP or any kind of hormonal products before IVF; azoospermia; having myoma or history of myomectomy; endometriosis.
Intervention group: Intra-uterine hCG injection 500 U single dose.
Control group: Without injection.
Primary outcome: (a) assessing pregnancy 2 weeks after intervention using pregnancy test; (b) assessing pregnancy sock 3 weeks after intervention using ultrasonography.
Secondary outcome: Assessing abortion before 20 weeks of pregnancy with taking history.
Randomization: Random assignment of the patients to the intervention and control groups one at a time.
Blinding: Not blinded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510079014N81
Registration date:2015-10-20, 1394/07/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-10-20, 1394/07/28
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intra-uterine hCG injection versus placebo in improving implantation in women fertilized with IVF method: a randomized clinical trial
Public title
Effect of intra-uterine hCG injection versus placebo in improving implantation in women fertilized with IVF method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 18 to 40 years; the cause of infertility is male sex.
Exclusion criteria: using OCP or any kind of hormonal products before IVF; azoospermia; having myoma or history of myomectomy; endometriosis.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2015-05-26, 1394/03/05
Ethics committee reference number
IR.UMSHA.REC.1394.70
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
assessing pregnancy
Timepoint
2 weeks after intervention
Method of measurement
using pregnancy test
2
Description
assessing pregnancy sock
Timepoint
3 weeks after intervention
Method of measurement
using ultrasonography
Secondary outcomes
1
Description
Assessing abortion
Timepoint
before 20 weeks of pregnancy
Method of measurement
with taking history
Intervention groups
1
Description
Intra-uterine hCG injection 500 U single dose
Category
Treatment - Drugs
2
Description
Without injection
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Sima Saffary
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Fatemieh Hospital
Full name of responsible person
Dr Sima Saffary
Position
Resident of Gynecology
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
simasaffary@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Dr Soghra Rabiee
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
rebieeso@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)