Clinical trail of comparison of pregnancy outcome in women with history of repeated implantation failure after intrauterine infusion of autologous platelet rich plasma (PRP) and women without intervention undergoing frozen thawed cycles
This is a phase 3 randomized clinical trial which is conducted in Yazd research and clinical center for infertility on two groups of 33 infertile women with history of minimum two repeated implantation failure or more between 18 to 42 years old after intrauterine infusion of autologous platelet rich plasma (PRP) and women without intervention undergoing frozen thawed cycles. In 2nd day of cycle the patients undergo a basic trans vaginal sonography. For all the women who enter in frozen thawed cycles, estradiol tablet 2mg three times daily is initiated. In 13th day of cycle trans vaginal sonograghy is done for the patients again. Those who have endometrial thickness above 8mm enter in the study. They are divided in 2 groups randomly with table of random numbers with computerized software. In interventional group PRP (plasma riches platelet) is infused intrauterine with(intra uterine insemination) IUI catheter. In both groups Progesterone vaginal suppository 400 mg twice daily is prescribed for 3 days then embryos in cleavage state are transferred. Chemical pregnancy is evaluated with checking Bhcg 2 weeks after embryo transfer and clinical pregnancy with trans vaginal sonography and observation of fetal heart 2 to 3 weeks after positive pregnancy test
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016090728950N3
Registration date:2016-11-26, 1395/09/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-26, 1395/09/06
Registrant information
Name
Nosrat Neghab
Name of organization / entity
Research and Clinical center for Infertility, Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 7085
Email address
nosratneghab@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trail of comparison of pregnancy outcome in women with history of repeated implantation failure after intrauterine infusion of autologous platelet rich plasma (PRP) and women without intervention undergoing frozen thawed cycles
Public title
Intrauterine infusion of autologous platelet rich plasma (PRP) on women with repeated frozen thawed cycles failure
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: women undergoing frozen thawed cycles; history of 2 or more history of implantation failure; age between 18 to 42
exclusion criteria: hematological and immunological disorders; hormonal disorders; chromosomal and genetic abnormalities; uterine abnormalities (congenital or acquired)
Age
From 18 years old to 42 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized allocation with computerized program we divide the patients randomly in intervention and control groups with table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Bouali Avenue, Safayeh, Yazd, Iran
City
Yazd
Postal code
8916877391
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.ssu.rsi.rec.1395.16
Health conditions studied
1
Description of health condition studied
female infertility
ICD-10 code
N97.9
ICD-10 code description
female infertility unspecified
Primary outcomes
1
Description
chemical pregnancy
Timepoint
2 weeks after embryo transfer
Method of measurement
serum pregnancy test
2
Description
clinical pregnancy
Timepoint
4 weeks after embryo transfer
Method of measurement
trans vaginal sonograghy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In 2nd day of cycle the patients undergo a basic trans vaginal sonography. For all the women who enter in frozen thawed cycles, estradiol tablet 2mg three times daily is initiated. In 13th day of cycle trans vaginal sonograghy is done for the patients again. Those who have endometrial thickness above 8mm enter in the study .They are divided in 2 groups randomly. In interventional group PRP (plasma riches platelet) is infused intrauterine with IUI catheter. Then Progesterone vaginal suppository 400 mg twice daily is prescribed for 3 days and embryos in cleavage state are transferred. .
Category
Treatment - Drugs
2
Description
Control group: In 2nd day of cycle the patients undergo a basic trans vaginal sonography. For all the women who enter in frozen thawed cycles, estradiol tablet 2mg three times daily is initiated. In 13th day of cycle trans vaginal sonograghy is done for the patients again. Those who have endometrial thickness above 8mm enter in the study .They are divided in 2 groups randomly. In control group, they continue routine protocol and Progesterone vaginal suppository 400 mg twice daily is prescribed for 3 days then embryos in cleavage state are transferred.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Research and Clinical Center for Infertility Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Maryam Eftkhar
Street address
Bouali Avenue, Safayeh, Yazd, Iran
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Dr Maryam Eftekhar
Street address
Bouali Avenue, Safayeh, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences, Vice chancellor for research
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
Yazd Research and Clinical Center for Infertility Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Nosrat Neghab
Position
Obstetrician &Gynecologist fellowship of infertility and IVF(studying)
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh, Yazd, Iran
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
nosrat20@yahoo.com; nosratneghab@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Research and Clinical Center for Infertility Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Maryam Eftekhar
Position
Obstetrician&Gynecologist fellowship of infertility and IVF associated professor
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh, Yazd, Iran
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
eftekharmaryam@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Research and Clinical Center for Infertility Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Nosrat Neghab
Position
ObstetricIan and gynecologist fellowship of infertility and IVF(studying)
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh, Yazd, Iran
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
nosratneghab@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)