Effects of platelet-rich plasma versus Hams F10 on the ovarian stimulation outcome in infertile women with poor ovarian response: a single blind randomized clinical trial
Objectives: To assess the effect of platelet-rich plasma versus Hams F10 on the ovarian stimulation outcome in infertile women with poor ovarian response
Design: a single blind randomized clinical trial.
Setting and conduct: The eligible infertile women with poor ovarian response who will refer to Fatemieh Hospital during the study period will be enrolled into the trial.
Inclusion criteria: age of 20 to 42 years; poor ovarian response (less than 3 ovule in each cycle).
Exclusion criteria: pregnancy contraindication; family history of ovarian cancer; presence of any type of chronic disease such as anemia or endocrine disorders or renal failure.
Intervention group: Intra-ovarian injection of 2 to 3 ml platelet-rich plasma once.
Control group: Intra-ovarian injection of 2 to 3 ml Hams once.
Primary outcome: (a) counting ovule one and eight weeks after intervention using microscope; (b) measuring FSH and LH before intervention and 4 weeks after intervention through laboratory evaluation.
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Patients will be unaware of the type of intervention. Therefore, the trial will be run as single blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201703079014N150
Registration date:2017-03-08, 1395/12/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-08, 1395/12/18
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
2017-01-04, 1395/10/15
Expected recruitment end date
2018-01-05, 1396/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of platelet-rich plasma versus Hams F10 on the ovarian stimulation outcome in infertile women with poor ovarian response: a single blind randomized clinical trial
Public title
Effects of platelet-rich plasma versus Hams F10 on the ovarian stimulation outcome in infertile women with poor ovarian response
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 20 to 42 years; poor ovarian response (less than 3 ovule in each cycle).
Exclusion criteria: pregnancy contraindication; family history of ovarian cancer; presence of any type of chronic disease such as anemia or endocrine disorders or renal failure.
Age
From 20 years old to 42 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Patients will be unaware of the type of intervention. Therefore, the trial will be run as single blind.
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
2017-03-04, 1395/12/14
Ethics committee reference number
IR.UMSHA.REC.1395.593
Health conditions studied
1
Description of health condition studied
infertile women
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
counting ovule
Timepoint
one and eight weeks after intervention
Method of measurement
using microscope
2
Description
measuring FSH and LH
Timepoint
before intervention and 4 weeks after intervention
Method of measurement
through laboratory evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intra-ovarian injection of 2 to 3 ml platelet-rich plasma once.
Category
Treatment - Drugs
2
Description
Control group: Intra-ovarian injection of 2 to 3 ml Hams once.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Safoura Heshmati
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 Safoura Heshmati
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
safouraheshmati@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Dr Marzieh Farimani
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
dr_farimani@.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)