Determination of the effect of intra-ovarian injection of platelet-rich plasma in patients with premature ovarian insufficiency.
Design
A clinical trial without control group, without blinding, phase 3, on 54 patients.
Settings and conduct
Female infertility Clinic of ROYAN institute.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with premature ovarian insufficiency according to european society of human reproduction and embryology (ESHRE) guideline; Body mass index <35 Kg/m2; Normal karyotype; Normal fragile X messenger ribonucleoprotein 1 (FMR1) gene. Exclusion criteria: Endocrine, autoimmune and hematological disorders; Genetic diseases and chromosomal disorders; History of cancer; Uterine anomalies; Endometriosis, severe adenomyosis, hydrosalpinx, and fibromatous uterus.
Intervention groups
Intervention group: Platelet-rich plasma (PRP) injection will be done on day 8-12 of the menstrual cycle. PRP injection will be performed less than 15 minutes after its preparation by the surgeon and gynecologist. The injection will be done through the vagina, under ultrasound guidance and with a follicle puncture needle. The injection is done under mild anesthesia and takes less than 15 minutes.
Main outcome variables
Serum level of follicle-stimulating hormone (FSH).
Serum level of Anti-Mullerian Hormone (AMH).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080831001141N41
Registration date:2023-02-08, 1401/11/19
Registration timing:registered_while_recruiting
Last update:2023-02-08, 1401/11/19
Update count:0
Registration date
2023-02-08, 1401/11/19
Registrant information
Name
Kiandokht Kiani
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2230 7960
Email address
kiandokht.kiani@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-01, 1401/11/12
Expected recruitment end date
2024-03-15, 1402/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of intra-ovarian injection of platelet-rich plasma in patients with premature ovarian insufficiency; a clinical trial
Public title
Intra-ovarian injection of platelet-rich plasma in patients with premature ovarian insufficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with premature ovarian insufficiency according to european society of human reproduction and embryology (ESHRE) guideline
Body mass index < 35 Kg/m2
Normal karyotype
Normal fragile X messenger ribonucleoprotein 1 (FMR1) gene
Exclusion criteria:
Endocrine, hematologic and autoimmune disorders
Chromosomal and genetic abnormalities
Cancer history
Uterine anomalies
Sever adenomyosis
Endometriosis
Hydrosalpinx
Uterine fibromatosis
Age
To 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
A clinical trial without control group, without blinding, phase 3, on 54 patients.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Royan Institute
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Approval date
2022-12-20, 1401/09/29
Ethics committee reference number
IR.ACECR.ROYAN.REC.1401.091
Health conditions studied
1
Description of health condition studied
Premature ovarian insufficiency
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Serum level of follicle-stimulating hormone (FSH)
Timepoint
6-8 weeks after intra-ovarian injection of platelet-rich plasma
Method of measurement
Blood test
2
Description
Serum level of anti-mullerian hormone (AMH)
Timepoint
6-8 weeks after intra-ovarian injection of platelet-rich plasma
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Platelet-rich plasma (PRP) injection will be done on day 8-12 of the menstrual cycle. PRP injection will be performed less than 15 minutes after its preparation by the surgeon and gynecologist. The injection will be done through the vagina, under ultrasound guidance and with a follicle puncture needle. The injection is done under mild anesthesia and takes less than 15 minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Center of ROYAN
Full name of responsible person
Mehri Mashayekhy
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2647
Email
dr.mashayekhy@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ROYAN Institute
Full name of responsible person
Parvaneh Afsharian
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2674
Fax
+98 21 2230 6481
Email
pafshar@royaninstitute.org
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ROYAN Institute
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
ROYAN Institute
Full name of responsible person
Mehri Mashayekhy
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2647
Fax
+98 21 2230 6481
Email
dr.mashayekhy@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
ROYAN Institute
Full name of responsible person
Mehri Mashayekhy
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2647
Fax
+98 21 2230 6481
Email
dr.mashayekhy@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
ROYAN Institute
Full name of responsible person
Mehri Mashayekhy
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2647
Fax
+98 21 2230 6481
Email
dr.mashayekhy@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available