The effect of intrauterine infusion of platelet-rich plasma and number of infusion on increasing the thickness of endometrium and pregnancy rate in patients with thin endometrium.
The effect of intrauterine infusion of platelet-rich plasma and number of infusion on increasing the thickness of endometrium and pregnancy rate in patients with thin endometrium.
Design
Randomized, not blinded, sham controlled clinical trial with a parallel group design of 20 patients, enrolled between January 2019 and July 2019, and followed for 20 weeks.
Settings and conduct
Twenty infertile women with thin endometrium on day 10 of freeze embryo transfer cycles who attending in infertility ward of Imam Khomeini Hospital, divided in two groups according to randomized number table, that once or twice platelet- rich plasma infusion on day 11 and 13 cycles. Changes in the ET, and pregnancy rate compared between the groups. Patients are aware and satisfied of the intervention, but the physician has no information about kind of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged between 20-40 years؛ BMI Between 20-30 kg/m2؛ Freez embryo transfer؛ Prior failed embryo transfer cycle due to thin endometrium؛ endometrial line below 7 on day 10 of cycle
Exclusion criteria: Abnormal uterine form conture on hystrosalpingography or hysteroscopy؛ Hematologic disease؛ Hormonal disorder
Intervention groups
Intervention group 1: 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 day 11 of freeze embryo transfer cycle.
Intervention group 2: 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 day 13 of freeze embryo transfer cycle.
Control group: Transfer of three Freeze embryos by chateter ( Cook, USA) under ultrasonographic guidance.
Main outcome variables
Increase in endometrial thickness rate؛ Clinical pregnancy rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160815029374N5
Registration date:2019-05-11, 1398/02/21
Registration timing:registered_while_recruiting
Last update:2019-05-11, 1398/02/21
Update count:0
Registration date
2019-05-11, 1398/02/21
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
2019-01-21, 1397/11/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intrauterine infusion of platelet-rich plasma and number of infusion on increasing the thickness of endometrium and pregnancy rate in patients with thin endometrium.
Public title
PRP in infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged between 20-40 years
BMI Between 20-30 kg/m2
Freez embryo transfer
Prior failed embryo transfer cycle due to thin endometrium
endometrial line below 7 on day 10 of cycle
without endometrial pathology on hystrosalpingography or hysteroscopy
Exclusion criteria:
Abnormal uterine form conture on hystrosalpingography or hysteroscopy
Hematologic disease
Hormonal disorder
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done based on the random number table on the day of estrogen initiation in freeze embryo transfer cycle by one nurse. In fact, only the nurse knows which patient is under the one or two PRP infusion. Physicians do not know which patient is undergoing one or two PRP, but patients know about the intervention due to informed consent,therefore, it is not possible to concealed the patients in this group.
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 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
2019-02-07, 1397/11/18
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1398.014
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
Increase in endometrial thickness rate
Timepoint
48 hours after intrauterine injections of platelet-rich plasma
Method of measurement
Ultrasound
2
Description
Clinical pregnancy rate
Timepoint
Forth weeks after embryo transfer
Method of measurement
Ultrasound
Secondary outcomes
1
Description
Miscarriage rates
Timepoint
Till twenty weeks after embryo transfer
Method of measurement
Questionnare
2
Description
Chemical pregnancy rate
Timepoint
Two weeks after embryo transfer
Method of measurement
B-HCG Kit
3
Description
Implantation rate
Timepoint
Forth weeks after embryo transfer
Method of measurement
Questionare
Intervention groups
1
Description
Intervention group: 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 day 11 of freeze embryo transfer cycle.
Category
Treatment - Other
2
Description
Intervention group: 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 day 13 of freeze embryo transfer cycle.
Category
Treatment - Other
3
Description
Control group: Transfer of three Freeze embryos by chateter ( Cook, USA) under ultrasonographic guidance.