Considering the effectiveness of acupuncture in the treatment of infertility, this study survey the effect of acupuncture on fertility in infertile women treated with in vitro fertilization in Shiraz's mother and child's hospital.
Design
The control group (n = 62), the acupuncture group 1 (62) and the acupuncture group 2 (62 patients), were randomized, double-blind, randomized
Settings and conduct
The present study was conducted as a prospective clinical trial on 186 infertile women. They were referred to maternal and child hospital of Shiraz University of Medical Sciences. Individuals in one group (62 patients) received acupuncture 25 minutes before embryo transfer (ACU1 group). In another group (62 subjects), acupuncture was given 25 minutes before and 25 minutes after embryo transfer (ACU2). The third group (n = 22) was the control group. The effects of interventions on fertility were evaluated by performing a pregnancy test.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20-50 years,Infertile women undergoing in vitro fertilization treatment,Patient satisfaction.
Exclusion criteria : Dissatisfaction with the patient.
Intervention groups
Individuals in one group (62 patients) received acupuncture 25 minutes before embryo transfer (Acupuncture1). In another group (62 patients) acupuncture was given 25 minutes before and 25 minutes after embryo transfer (acupuncture2). The third group was control (n = 62). The effect of interventions on pregnancy rate was assessed 4-8 weeks after embryo transfer by performing a pregnancy test.
Main outcome variables
Comparison of pregnancy rate after intervention was considered for the initial outcome of the study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150511022206N4
Registration date:2018-02-13, 1396/11/24
Registration timing:registered_while_recruiting
Last update:2018-02-13, 1396/11/24
Update count:0
Registration date
2018-02-13, 1396/11/24
Registrant information
Name
Alamtaj Samsami
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3227 9715
Email address
samsamia@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of the acupuncture on the success of in vitro fertilization in infertile women
Public title
Effect of acupuncture on fertility in infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women with aged between 20-50 years undergoing IVF treatment
Exclusion criteria:
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
186
Randomization (investigator's opinion)
N/A
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 Shiraz University of Medical Sciences
Street address
Building of Shiraz University Of Medical Science, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
1433671348
Approval date
2015-04-19, 1394/01/30
Ethics committee reference number
IR.SUMS.1394.20
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Inability to achieve a pregnancysterility, female NOS
Primary outcomes
1
Description
Comparison of pregnancy rate after intervention.
Timepoint
4-8 weeks after embryo transfer.
Method of measurement
Pregnancy test.
Secondary outcomes
empty
Intervention groups
1
Description
Acupuncture was performed in 124 patients 25 min before and after ET
Category
Treatment - Other
2
Description
Control group: 62 patients embryo transfer was performed without acupuncture.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Ghadir Mother and Child Subspecialized Hospital
Full name of responsible person
Zeynab Kanannejad
Street address
Emam-Reza blvd,Shiraz Ghadir Mother and Child Subspecialized Hospital
City
Shiraz
Province
Fars
Postal code
71348-44119
Phone
+98 71 3227 9715
Email
nabarresh1@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
71348-44119
Phone
+98 71 3230 5410
Email
hashemib@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zeynab Kanannejad
Position
Resident of gynecology and obstetrics
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3227 9715
Fax
Email
s.kharati@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Alamtaj Samsami
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-44119
Phone
+98 71 3227 9715
Fax
Email
samsamia@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Kharati
Position
Expert infertility research center
Latest degree
Bachelor
Other areas of specialty/work
Occupational Health
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3227 9715
Fax
Email
s.kharati@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Completion of Ethic form
When the data will become available and for how long
After completing the project
To whom data/document is available
Patient or guardian
Under which criteria data/document could be used
Notice the result of the treatment
From where data/document is obtainable
Department of obstetrics and gynecology, Shahid Faghihi Hospital
What processes are involved for a request to access data/document