Investigation of the effects of intraovarian platelet rich plasma and rFSH injection on infertile patients
Design
This non randomized clinical trial with case and control groups is conducted on 30 women with convenience sampling after consulting the patient and her partner.Each patient's response will be compared with the previous own IVF cycle.Care provider and analyser are blinded regarding groups.
Settings and conduct
Poor responder in IVF cycle at Yas Hospital that are candidates for egg donation,are included.
Participants/Inclusion and exclusion criteria
Inclusion critria: 20-45 years old women with historyof poorovarianresponse in previous cycle.
Exclusion criteria: Male infertility, Ovarian failure due to gonadal dysgenesis
Intervention groups
Intervention group: rFSH and platelet rich plasma is obtained from patients peripheral blood and injected in the ovaries by transvaginal ultrasonographic guidance under anesthesia at day of OPU.
Control group:Oocyte punctuer will be performed by ultrasonographic guidance under anesthesia at day of OPU and after three months ovarian function will be compared.
Main outcome variables
Three months after intervention, 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:IRCT20091012002576N33
Registration date:2023-09-16, 1402/06/25
Registration timing:prospective
Last update:2023-09-16, 1402/06/25
Update count:0
Registration date
2023-09-16, 1402/06/25
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
2023-09-23, 1402/07/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of intraovarian platelet rich plasma and recombinant FSH injection on infertile women with poor ovarian response
Public title
Effects of intraovarian PRP, rFSH injection in poor ovarian responder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Abnormal ovarian reserve test.
Antral follicle count<5.
At least one previous IVF cycle <3oocyte was retrieved.
Exclusion criteria:
Ovarian insufficiency due to gonadal dysgenesia and abnormality of chromosoms
Male infertility
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran University of medical sciences
Street address
Deputy of Research, central building of Tehran University of medical sciences, Ghods Avenue, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
159781597815
Approval date
2023-08-30, 1402/06/08
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.304
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
Female inf
ICD-10 code description
N97.8
Primary outcomes
1
Description
FSH,LH,AMH,Esteradiol levels
Timepoint
Before and three months after intervention
Method of measurement
Laboratory tests
2
Description
Chemical pregnancy
Timepoint
Two weeks after embryo transfer
Method of measurement
Bhcg tests
3
Description
Number of MII oocyte
Timepoint
Three months after intervention
Method of measurement
Embryologist report
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
Four weeks after embryo transfer
Method of measurement
Heart beat activity in transvaginal sonogram
Intervention groups
1
Description
Intervention group:r FSH and platelet reach plasma that is prepared from patient's peripheral blood and injected in the ovarian tissue by transvaginal ultrasonographic guidance at the day of oocyte punctuer under anesthesia after three months, ovarian function will be compared with pervious cycle.
Category
Treatment - Drugs
2
Description
Control group: Under anesthesia and ultrasonographic guidance at the day of oocyte puncture will be performed and after three months, ovarian function will be compared with pervious cycle.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
YAS hospital
Full name of responsible person
Fatemeh Davari Tanha
Street address
North Nejatollahi Avenue, Karim khan Zand Bridge, Villa Street
City
Tehran
Province
Tehran
Postal code
159781597815
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Deputy of Research, sixth floor of central building of Tehran University of medical sciences, Ghods Avenue, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
159781597815
Phone
+98 21 8889 7761
Email
afotouhi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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, Karim khan Zand, Villa Street
City
Tehran
Province
Tehran
Postal code
159781597815
Phone
0098218889800115
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
Tehran
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North Nejatollahi Avenue, Karim khan Zand Bridge, Villa Street
City
Tehran
Province
Tehran
Postal code
159781597815
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, Karim khan Zand Bridge, Villa Street
City
Tehran
Province
Tehran
Postal code
159781597815
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
Undecided - It is not yet known if there will be 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
Outcome data
When the data will become available and for how long
After publishing article
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Mention in references
From where data/document is obtainable
Request by email
What processes are involved for a request to access data/document