This study was designed to evaluate the effectiveness of intrauterine infusion of platelet-rich plasma (PRP) in improvement of endometrial growth and implantation in in vitro fertilization (IVF) cycles. This clinical trial is performed in Infertility and IVF ward, Taleghani hospital. 30 infertile patients with history of three or more failed implantation or thin endometrium are recruited into the study in two groups according to randomization method. Intrauterine infusion of platelet rich plasma (PRP) or dummy catheter is performed for thin endometrium and this procedure is repeated if necessary after 48 hours and 2 days before embryo transfer in recurrent implantation failure. Endometrial growth, chemical pregnancy and clinical pregnancy rate will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072229027N1
Registration date:2016-09-05, 1395/06/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-05, 1395/06/15
Registrant information
Name
Leila Nazari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8000
Email address
nazari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, school of medicine, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-12-16, 1394/09/25
Expected recruitment end date
2017-12-16, 1396/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of autologous platelet rich plasma on endometrial growth and implantation in intracytoplasmic sperm injection cycles: clinical trial
Public title
Effects of platelet rich plasma on frozen embryo transfer process
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Body mass index (BMI) below 30; unadequate endometrium (endometrial thickness below 7 mm); history of hematologic disease3 failed embryo transfer
Exclusion criteria: history of hematologic disorders; uterine abnormality (acquired or congenital); unwillingness to continue
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization method: table of randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak, Yaman St, Chamran highway
City
Tehran
Postal code
Approval date
2015-12-15, 1394/09/24
Ethics committee reference number
IR.SBMU.SM.REC.1394.92
Health conditions studied
1
Description of health condition studied
Noninflammatory disorders of female genital tract
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
4 weeks after embryo transfer
Method of measurement
Transvaginal ultrasound
2
Description
Chemical pregnancy
Timepoint
2 weeks after embryo transfer
Method of measurement
Serum BHCG
3
Description
Endometrial thickness
Timepoint
48 hours after PRP
Method of measurement
The most ndometrial thickening in transvaginal ultrasound
Secondary outcomes
1
Description
Ongoing pregnancy
Timepoint
10 weeks after embryo transfer
Method of measurement
Fetal heart beat in ultrasound
2
Description
Abortion
Timepoint
Before 20 weeks of pregnancy
Method of measurement
Fetal demise before 20 weeks of gestation
Intervention groups
1
Description
Intervention group: Intrauterine infusion of 0.5 ml platelet rich plasma (PRP) that contained platelet 4-5 times more than peripheral blood with uterine catheter is performed if endometrial thickness below 7 mm on day 13-14 of cycle and the procedure is repeated 48 hours later if the endometrial thickness below 7 mm, although the procedure is performed 48 hours before embryo transfer in repeated implantation failure
Category
Treatment - Other
2
Description
Control group: Dummy catheter (sham catheter) is performed if endometrial thickness below 7 mm on day 13-14 of cycle and the procedure is repeated 48 hours later if the endometrial thickness below 7 mm, although the procedure is performed 48 hours before embryo transfer in repeated implantation failure
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility and IVF ward of Talghani hospital
Full name of responsible person
Leila Nazari
Street address
Yaman St, Velenjak, Chamran highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Yaman st, Velenjak, Chamran highway
City
Tehran
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 of Shahid Beheshti University of Medical Sciences