The effect of intraovarian injection of Calcium Gluconate-activated platelet-rich plasma (PRP) on infertile women with diminished ovarian reserve: A before after clinical trial
Detect of effectivness of intraovarian injection of Calcium Gluconate-activated platelet-rich plasma on infertile women with diminished ovarian reserve
Design
Before and after Clinical trial, without control group, not blind, not randomized
Settings and conduct
Ten infertile women with at least one failed invitro fertilization and diminished ovarian reserve or premature ovarian failure who attending in infertility department in Imam khomaini Hospital, Mazandaran University of Medical Sciences, Sari, Iran, will be evaluated before and after intraovarian injection of platelet. Patients and physician are aware of intervention and patients' consent to enter the study is obtained
Participants/Inclusion and exclusion criteria
Women aged 20-45 year diminished ovarian reserve
Body mass index lower than 30 Kilogram per square meter
At least one prior failed in vitro fertilization
Premature ovarian failure
Intervention groups
Intrauterine infusion of 0.5 CC of autologus platelet-rich plasma (has 4-6 times platelet concentration rather than peripheral blood by IUI catheter (Takvin company, Iran) on oocyte pick up day.
Main outcome variables
Change in Anti mulerian hormone level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160815029374N7
Registration date:2019-06-20, 1398/03/30
Registration timing:registered_while_recruiting
Last update:2019-06-20, 1398/03/30
Update count:0
Registration date
2019-06-20, 1398/03/30
Registrant information
Name
Marzieh Zamaniyan
Name of organization / entity
Mazandaran University of Medical Sciences, Sari, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 5724
Email address
m.zamanian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-29, 1397/11/09
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intraovarian injection of Calcium Gluconate-activated platelet-rich plasma (PRP) on infertile women with diminished ovarian reserve: A before after clinical trial
Public title
Platelet-rich plasma effect in infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diminished ovarian reserve
At least one prior failed in vitro fertilization
Body mass index lower than 30 Kilogram per square meter
Premature ovarian failure
Ethics committee of Mazandaran University of Medical Sciences
Street address
No. 5, third floor, Cancer ward, Imam Khomeini Hospital, Amir Mazandarani Ave, Diabetes Research Center.
City
Sari
Province
Mazandaran
Postal code
3313148166
Approval date
2019-01-28, 1397/11/08
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1398.007
Health conditions studied
1
Description of health condition studied
Diseases of the genitourinary system
ICD-10 code
N97; N98
ICD-10 code description
Female infertility; Complications associated with artificial fertilization
Primary outcomes
1
Description
Change in Anti mulerian hormone level
Timepoint
Two weeks after oocyte pick up compared with two week before injection of of Calcium Gluconate-activated platelet-rich plasma (the day of pick up oocyte)
Method of measurement
Assaying this factor in blood serum is done by laboratory methods and the corresponding kit
2
Description
Changes in the level of follicular stimulating hormone
Timepoint
Two weeks after oocyte pick up compared with two week before injection of of Calcium Gluconate-activated platelet-rich plasma (the day of pick up oocyte)
Method of measurement
Assaying this factor in blood serum is done by laboratory methods and the corresponding kit
3
Description
Change in estradiol level
Timepoint
Two weeks after oocyte pick up compared with two week before injection of of Calcium Gluconate-activated platelet-rich plasma (the day of pick up oocyte)
Method of measurement
Assaying this factor in blood serum is done by laboratory methods and the corresponding kit
Secondary outcomes
1
Description
Change in Antral fulicular counts
Timepoint
The third day of menstruation and before B-HCG injection
Method of measurement
by ultrasound and folliculography
2
Description
Change in oocyte numbers
Timepoint
Two months after Calcium Gluconate- activated platelet-rich plasma injection comparison with the day of Oocyte pick up
Method of measurement
evaluation by microscope and ultrasound
3
Description
Pregnancy rate
Timepoint
Three monthes after Calcium Gluconate - activated platelet-rich plasma injection then survey chemical and clinical pregnancy
Method of measurement
Positive beta hCG rate and clinical pregnancy rates
4
Description
Change in embryos numbers
Timepoint
Two months after intraovarian injection of platelet
Method of measurement
by counting frozen embryo in embryo bank
Intervention groups
1
Description
Intervention group: Intrauterine infusion of 0.5 CC of autologus Calcium Gluconate- activated platelet-rich plasma (has 4-6 times platelet concentration rather than peripheral blood by IUI catheter(Takvin company, Iran) on day of oocyte pick up.