Protocol summary

Summary
Overal Objective: Evaluation of the effect of intrauterine infusion of platelet-rich plasma(PRP)on endometrial thickness in infertile women that have insufficient endometrial thickness in frozen embryo transfer cycles tients treated for frozen embryo transfer cycles after intrauterine infusion of PRP The endometrial thickness in patients treated for frozen embryo transfer cycles without intrauterine infusion of PRP Compare the endometrial thickness in patients treated for frozen embryo transfer cycles after intrauterine infusion of PRP and control group pregnancy rate in patients treated for frozen embryo transfer cycles after intrauterine infusion of PRP pregnancy rate in patients treated for frozen embryo transfer cycles without intrauterine infusion of PRP compare pregnancy rate in patients treated for frozen embryo transfer cycles after intrauterine infusion of PRP and group control Material and Method: In this study 100 infertile patients who have came to infertility clinic of mother and child hospital for transfer frozen embryo that have endometrial thickness less than 6 mm despite conventional treatment with low dose 6 mg estradiol in 10th day cycles.they randomized and divided to groups of 50 patients and after taking testimonial from study will start .excluding factors :platelet dysfunction syndrome ,thrombocytopenia ,continued use of the NSAIDS in the past 48 hours ,use corticosteroid during the past month,smoking,history of cancer ,recent fever ,plt<105000 In conventional treatment method Estradiol Valerate at 6 mg per day was given on day 2 of menstruation cycle and in all case to 8 mg increases and the maximum dose was 8 mg per day .similarly in first group the medication is continued and second group candidate for PRP. On the 10th day of HRT cycle 15 cc of venous blood was dramn from the syringe pre-filled with 5 cc of anticoagulant solution (ACD-A)and centrifuged immediately at 200 gr for 10 min .the blood was divided into three layers:red blood cells at the bottom ,cellular plasma in the supernatant and a buffy coat layer between them,the plasma layer and buffy coat were collected to another tube and re centrifuged 500 gr for 10 min.the resulting plellet of platelets was mixed with 1 cc of supernatant and then 0.5-1 cc of PRPwas obtained. It was infused into the uterus cavity immidiatly with Tomcat catheter .endometrial thickness was re-assessed 72 hour later .if the endometrial thickness was satisfied infusion of PRP was performed in 72 hr after first infusion. At last 2 group of case and control will be compared with each other by endometrial thickness before and after PRP infusion ,implantation rate ,pregnancy rate and number of canceling cycles.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016102510210N6
Registration date: 2016-10-30, 1395/08/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-10-30, 1395/08/09
Registrant information
Name
Afsun Zarei
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
zareia@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz university of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of intrauterine infusion of autologous platelet-rich plasma(PRP)on endometrial thickness and pregnancy rate as secondary endpoint in FET cycles.
Public title
effect of platelet-rich plasma(PRP)on fertility in women with thin endometrium
Purpose
Treatment
Inclusion/Exclusion criteria
All patient with infertility that refer to mother and child hospital due to embryo transfer and recently despite conventional treatment with low dose of estradiol(6 mg)in 10th day cycles have endometrial thickness less than 6 mm no have above factors or no agree of patients platelet dysfunction ,thrombocytopenia ,continue using NSAIDs in the recent 48 hours ,corticosteroids in the 1 mount before ,smoking ,recent fever, history of cancer ,Hb<,platelet<105000
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: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Science Researching، Shiraz Univercity of Medical Science
Street address
Shiraz University of Medical Sciences، Zand Street، Shiraz
City
Shiraz
Postal code
Approval date
2016-04-10, 1395/01/22
Ethics committee reference number
IR.SUMS.REC.1395.25

Health conditions studied

1

Description of health condition studied
noninflammatory disorder of female genital tract
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization ,unspecified

Primary outcomes

1

Description
Endometrial thickness
Timepoint
in 10th day of cycles and 72 hr after infusion of PRP
Method of measurement
Trans vaginal sonography

Secondary outcomes

1

Description
clinical pregnancy or miscarriage
Timepoint
4week after embryo transfer
Method of measurement
trans vaginal sonography

Intervention groups

1

Description
Control group: Continue estradiol since day 2 of cycle till end of study
Category
Treatment - Drugs

2

Description
- Intrauterine infusion of 0.5 cc of platelet rich plasma( PRP)that contained platelet 4-5 times more than peripheral blood with uterine catheter is performed if endometrial thickness below 6 mm on day 10 of cycle and the procedure is repeated 72 hours later if the endometrial thickness below 6mm
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Mother & Child Hospital،
Full name of responsible person
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University Of Medical Science
Full name of responsible person
Dr Basir Hashemi
Street address
Shiraz University of Medical Sciences، Zand Street،Shiraz
City
Shiraz
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 Science
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
Shiraz University Of Medical Science
Full name of responsible person
Mohadese Shirbani
Position
Resident Of GYN
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences ، Zand Street
City
Shiraz
Postal code
Phone
+98 71 3227 9715
Fax
Email
shirbanim@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Afsoon Zarei
Position
Fellowship Infertility
Other areas of specialty/work
Street address
Shiraz University of Medical Science , Zand Street
City
Shiraz
Postal code
Phone
+98 71 3227 9715
Fax
Email
zareia@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Sara Kharati
Position
Expert Infertility Research Center
Other areas of specialty/work
Street address
Shiraz University of Medical Science , Zand Street
City
Shiraz
Postal code
Phone
+98 71 3227 9715
Fax
Email
s.kharati@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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