Clinical trial of pregnancy outcome in women with thin endometrium after intrauterine infusion of autologous platelet rich plasma (PRP) in comparison with women with thin endometrium without intervention undergoing frozen thawed cycles
Objective: This study compares pregnancy outcome in two groups of 33 infertile women between 18 to 42 years with thin endometrium after intrauterine infusion of autologous platelet rich plasma (PRP) and thin endometrium women without intervention undergoing frozen thawed cycles.Design: this is a randomized clinical trial phase 3 study which is conducted in Yazd research and clinical center for infertility.Setting and conduct: in 2nd day of cycle a basic trans vaginal sonography is performed for the women. 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.Participants: those who have endometrial thickness below 7mm enter in the study. They are divided in 2 groups randomly with table of random numbers with computerized software. In control group estradiol is continued for another 3 days Intervention: in interventional group PRP is infused intrauterine with IUI (intra uterine insemination) catheter. Endometrial thickness is measured after 48 hours. If endometrial thickness doesn't reach 7mm or above, the second dose of PRP will infuse. After 48 hours the endometrial thickness is measured and for whom with endometrial thickness above 7mm vaginal suppository Progesterone400 mg twice daily is prescribed for 3 days then embryos in cleavage state are transferred.Main outcome measures: chemical pregnancy is evaluated with checking Bhcg 2 weeks after embryo transfer and clinical pregnancy is proved 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:IRCT2016090328950N2
Registration date:2017-01-10, 1395/10/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-10, 1395/10/21
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
Yazd 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 trial of pregnancy outcome in women with thin endometrium after intrauterine infusion of autologous platelet rich plasma (PRP) in comparison with women with thin endometrium without intervention undergoing frozen thawed cycles
Public title
Evaluation of intrauterine infusion of autologous platelet rich plasma (PRP) on in vitro fertilization (IVF)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women undergoing frozen thawed cycles; endometrial thickness less than 7 mm in 13 th day of cycle; 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 with table of random numbers with computerized software
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd 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.1395.17
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
endometrial thickness
Timepoint
13th, 15th day of menstural cycle and in some patients 17th day of cycle
Method of measurement
trans vaginal sonograghy
Secondary 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
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 below 7mm enter in the study. PRP is infused intrauterine with IUI (intra uterine insemination) catheter. Endometrial thickness is measured after 48 hours. If endometrial thickness doesn't reach 7mm or above, the second dose of PRP will infuse. After 48 hours the endometrial thickness is measured and for whom with endometrial thickness above 7mm vaginal suppository Progesterone400 mg twice daily is prescribed for 3 days then 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 below 7mm enter in the study. They are divided in 2 groups randomly. In control group estradiol is continued for another 3 days .When endometrial thickness reaches 7mm or above, vaginal suppository Progesterone400 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 Ali Mohammad Abdoli
Street address
Bahonar square, 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
nosratneghab@ssu.ac.ir; nosrat20@yahoo.com
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 & 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.irnosrat20@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)