Comparison of intrauterine injection effects of PRP (platelet-rich plasma) and Hams F10 on the pregnancy outcome in recurrent implantation failure of infertile women after transferring unfrozen embryo
Objectives: To compare the effect of platelet-rich plasma versus Hams F10 on the pregnancy outcome in infertile women with recurrent implantation failure after transferring unfozen embryo. Design: a single blind randomized clinical trial. Setting and conduct: The eligible infertile women who will refer to Fatemieh Hospital during the study period will be enrolled into the trial. Inclusion criteria: age of 20 to 42 years; implantation failure for at least 3 times. Exclusion criteria: pregnancy contraindication; weak response to gonadotropin; presence of any type of chronic disease such as anemia or endocrine disorders or renal failure. Intervention group: Intrauterine injection of 0.5 to 1 ml platelet-rich plasma 24 to 36 hours before implantation. Control group: Intrauterine injection of 0.5 to 1 ml Hams F10, 24 to 36 hours before implantation. Primary outcome: (a) Assessing pregnancy with βhCG 2 weeks after intervention; (b) assessing pregnancy with ultrasonography 4 weeks after intervention. Secondary outcome: Nothing. Randomization: Random assignment of the patients to the intervention and control groups. 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:IRCT2017033133179N1
Registration date:2017-04-08, 1396/01/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-08, 1396/01/19
Registrant information
Name
Nasrin Azami Fard
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3525 0182
Email address
itc@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2016-10-29, 1395/08/08
Expected recruitment end date
2017-04-28, 1396/02/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intrauterine injection effects of PRP (platelet-rich plasma) and Hams F10 on the pregnancy outcome in recurrent implantation failure of infertile women after transferring unfrozen embryo
Public title
Comparison of intrauterine injection effects of PRP (platelet-rich plasma) and Hams F10 on the pregnancy outcome in recurrent implantation failure of infertile women after transferring unfrozen embryo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 20 to 42 years; implantation failure for at least 3 times. Exclusion criteria: pregnancy contraindication; weak response to gonadotropin; 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
N/A
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: Here block randomization technique is used. For this purpose we provide 4 paper sheets and on two papers, letter "I" (intervention) is written and on another two papers letter "P" (placebo). Then papers are mixed once and are put in the drawer. After visiting a candidate, one of the papers is given to her whether "I" or "P". By this method candidates are allocating in intervention or placebo group randomly.
Blinding: Here only researchers but not the subjects know which subjects are receiving the treatment, therefore it is a single blind study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences
Street address
Khajeh Rashid Cross, Ayatollah Kashani Blv
City
Hamadan
Postal code
Approval date
2016-10-29, 1395/08/08
Ethics committee reference number
IR.UMSHA.REC.1395.342
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
with βhCG
Secondary outcomes
1
Description
Assessing pregnancy
Timepoint
4 weeks after intervention
Method of measurement
with ultrasonography
Intervention groups
1
Description
Intrauterine injection of 0.5 to 1 ml platelet-rich plasma 24 to 36 hours before implantation
Category
Treatment - Drugs
2
Description
Intrauterine injection of 0.5 to 1 ml Hams F10 24 to 36 hours before implantation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital, Hamadan
Full name of responsible person
Dr Nasrin Azami Fard
Street address
Fatemieh Hospital, Pasdaran Ave. Hamadan
City
Hamedan
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
Hamadan University of Medical Sciences
Full name of responsible person
Dr Nasrin Azami Fard
Position
Gynecology resident
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3821 9905
Fax
Email
nazami51@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
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
Hamadan University of Medical Sciences
Full name of responsible person
Dr Nasrin Azami Fard
Position
Gynecology resident
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3821 9905
Fax
Email
nazami51@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)