Determination of the effect of intra-ovarian injection of platelet-rich plasma in patients with poor ovarian response.
Design
A randomized clinical trial with control group, open label, two arm parallel group design of 200 patients. Randomization is performed using a computer-generated random assignment schedule for each patient. Sealed and numbered envelopes are used to conceal the treatment allocation until randomization.
Settings and conduct
Female infertility Clinic of ROYAN institute.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with a history of at least one poor ovarian response; Age ≤44 years; BMI <35 kg/m2; FSH <25 IU/L; AMH <1.2 ng/ml. Exclusion criteria: Endocrine, autoimmune and hematological disorders; Genetic diseases and chromosomal disorders; History of cancer; Uterine anomalies; Endometriosis, severe adenomyosis, hydrosalpinx, fibromatous uterus.
Intervention groups
Intervention group: 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 (Reproline medical GmbH, single lumen without flushing, 17 GAUGE, D-53359 Rheinbach, Germany). The injection is done under mild anesthesia and takes less than 15 minutes.
Main outcome variables
Antral follicles count, and serum level of antimullerin hormone
General information
Reason for update
Acronym
PRP-POR
IRCT registration information
IRCT registration number:IRCT20080831001141N40
Registration date:2023-01-17, 1401/10/27
Registration timing:prospective
Last update:2023-01-17, 1401/10/27
Update count:0
Registration date
2023-01-17, 1401/10/27
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 poor ovarian response; a randomized controlled clinical trial
Public title
Intra-ovarian injection of platelet-rich plasma in patients with poor ovarian response
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a history of at least one poor ovarian response
Age ≤44 years
BMI <35 kg/m2
FSH <25 IU/L
AMH <1.2 ng/ml
Exclusion criteria:
Endocrine, autoimmune and hematological disorders
Genetic diseases and chromosomal disorders
History of cancer
Congenital uterine anomalies
Endometriosis, severe adenomyosis, hydrosalpinx, fibromatous uterus
Age
To 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method is designed by epidemiologist using STATA software version 13 and the number of blocks considered is 8. The random allocation list for patients is solely available to the epidemiologist. In order to hide the random allocation process, a total of 200 envelopes are prepared, and only the methodologist has been aware of table of random numbers. When the doctor declared the patient's eligibility, the methodologist provided the doctor with the envelope. The group will be selected and based on the type of group mentioned in the envelope.
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
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.1401.089
Health conditions studied
1
Description of health condition studied
Decreased ovarian reserve
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Increased ovarian reserve: increased number of antral follicles, and increased levels of antimullerin hormone.
Timepoint
6-8 weeks after intraovarian injection of platelet-rich plasma
Method of measurement
Doppler ultrasound and blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 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 (Reproline medical GmbH, single lumen without flushing, 17 GAUGE, D-53359 Rheinbach, Germany). The injection is done under mild anesthesia and takes less than 15 minutes.
Category
Treatment - Other
2
Description
Control group: no intervention is done for the patients of this group.
Category
N/A
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
Fax
+98 21 2230 6481
Email
dr.mashayekhy@yahoo.com
Web page address
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)
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Clinical study report (published article)
When the data will become available and for how long
After the publication of the article
To whom data/document is available
Available to the public.
Under which criteria data/document could be used
Scientific use by citing the source.
From where data/document is obtainable
Dr. Mehri Mashayekhy
Email: dr.mashayekhy@yahoo.com
What processes are involved for a request to access data/document