The effects of intraovarian platelet rich plasma injection on infertile women with poor ovarian response in Yas Hospital and evaluation of ovarian response to next IVF cycle
Investigation of the effects of intraovarian platelet rich plasma injection on infertile women with poor ovarian response
Design
This clinical trial is studied on 20 women with convenience sampling after consulting the patient and her partner.Each patient's response will be compared with the previous own IVF cycle.
Settings and conduct
This study is going to be conducted at Yas Hospital on the women who previously received conventional infertility treatments and now they are candidates for egg donation. The patient and the physician who does the intervention can not be blinded but the follow up and data analysis are blinded.At 14 th day of cycle under analgesia PRP is performed by transvaginal ultrasonography and needle of ovarian puncthuer.
Participants/Inclusion and exclusion criteria
Inclusion critria:
- 20-45 years old women
-At least one previous IVF cycle with three or less ova and one of the followings:
An abnormal ovarian reserve test
Antral follicular count less than five follicles
- Egg donation candidate
Exclusion criteria:
- Male infertility
Ovarian failure due to gonadal dysgenesis or chromosomal abnormalities
Intervention groups
Platelet reach plasma is obtained from patients peripheral blood and injected in the ovaries by transvaginal ultrasonographic guidance under anesthesia.
Main outcome variables
FSH, LH, ESTRADIOL and anti-mullerian hormone (AMH) level, antral follicular count and menstruation pattern before PRP and monthly until three months after that are controlled; then patients undergo IVF and the numbers of oocyte, chemical ,clinical pregnancy outcome are followed.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002576N19
Registration date:2020-08-21, 1399/05/31
Registration timing:registered_while_recruiting
Last update:2020-08-21, 1399/05/31
Update count:0
Registration date
2020-08-21, 1399/05/31
Registrant information
Name
Fatemeh Davari Tanha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3955
Email address
fdavaritanha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-07-22, 1400/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of intraovarian platelet rich plasma injection on infertile women with poor ovarian response in Yas Hospital and evaluation of ovarian response to next IVF cycle
Public title
The effects of intraovarian platelet rich plasma injection on infertile women with poor ovarian response
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 25-40 years old
Abnormal ovarian reserve test
Antral follicle count<5
At least one previous IVF cycle <oocyte was retrieved
Exclusion criteria:
Ovarian insufficiency due to gonadal dysgenesia and abnormality of chromosoms
Male infertility
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:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethic commitee of Tehran University of Medical sciences
Street address
North Nejatollahi Avenue- Yas Hospital
City
Tehran
Province
Tehran
Postal code
15786
Approval date
2020-07-22, 1399/05/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.257
Health conditions studied
1
Description of health condition studied
Female infertility due to poor ovarian response, egg donation candidate
ICD-10 code
N97.8
ICD-10 code description
female infertility of other origin
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
After fetal transfer
Method of measurement
Ultrasound
Secondary outcomes
1
Description
Chemical pregnancy
Timepoint
Two weeks after fetal transfer
Method of measurement
Laboratory positive beta HCG test
2
Description
Gestational sac by transvaginal sonography
Timepoint
Three weeks after embryo transfer
Method of measurement
Transvaginal sonography
3
Description
Fetal heart activity by transvaginal sonography
Timepoint
Four weeks after embryo transfer
Method of measurement
Ultrasound
4
Description
FSH,LH,AMH,Esteradiol
Timepoint
Before and 3 months after intervention
Method of measurement
Laboratory tests
Intervention groups
1
Description
Intervention group: platelet reach plasma is prepared from patient's peripheral blood and injected in the ovarian tissue by transvaginal ultrasonographic guidance under anesthesia.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas Hospital
Full name of responsible person
فاطمه داوری تنها
Street address
Yas Hospital, North Ostad Nejatollahi St., Villa St., Karimkhan bridge
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8894 8218
Email
fatedavtanha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari-Tanha
Street address
North Nejatollahi Avenue- Yas Hospital
City
Tehran
Province
Tehran
Postal code
15978
Phone
+98 21 8880 0115
Email
fatedavtanha@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
معاونت پژوهشی دانشگاه علوم پزشکی تهران
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari-Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North Nejatollahi Avenue-Yas Hospital
City
Tehran
Province
Tehran
Postal code
15978
Phone
+98 21 8880 0115
Email
fatedavtanha@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari-Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North Nejatollahi Avenue-Yas Hospital
City
Tehran
Province
Tehran
Postal code
15978
Phone
+98 21 8880 0115
Email
fatedavtanha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari-Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North Nejatollahi Avenue- Yas Hospital
City
Tehran
Province
Tehran
Postal code
15978
Phone
+98 21 8880 0115
Email
fatedavtanha@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Project report to Deputy of Research of TUMS, every researcher who needs data for research.
When the data will become available and for how long
Two years
To whom data/document is available
Deputy of Research of TUMS,every researcher who needs data for research.
Under which criteria data/document could be used
Final report and published the results,data is delivered to every researcher who needs it for research or systematic review .
From where data/document is obtainable
Miss Moamaei-Deputy of Research of TUMS,fifth floor,Central building of TUMS,Ghods ave.,
Tel:00982164431
What processes are involved for a request to access data/document
Miss Moamaei-Deputy of Research of TUMS or send the request to fatedavtanha@gmail.com, responsible author, after 7 days I will respond