Investigating the effectiveness of intraovarian injection of platelet rich plasma on ovarian reserve in infertile women due to decreased ovarian reserve
A Pre/Post study of intra-ovarian PRP injection efficacy in infertile women due to diminished ovarian response in Shohadaye-Tajrish and Taleqani general hospitals through 2022-2023
Design
In all women included in the study, on the first to third day of menstruation under ultrasound (if there is no follicle above 10 mm and the thickness of the endometrium is below 5 mm and ovulation) and treatment with Pergoveris injectable gonadotropin twice a day, and when the growing follicle reaches 12-14 mm in size, GnRH antagonist (0.25 mg/day cetrotide) will be started subcutaneously. This injection will continue until the day of (ovitrelle (recombinant HCG (250 micrograms)) administration. When the dominant follicle reaches 18 mm, ovulation is induced using (ovitrelle (recombinant HCG (250 micrograms)) and transvaginal oocyte retrieval during 34 to 36 hours after the injection (ovitrelle (recombinant HCG (250 micrograms)) will be performed with an ultrasound guide. On the day of ovulation, after ovarian puncture, 3 cc of PRP injection will be performed. If the IVF cycle fails, on the third Menstrual cycle After checking the serum level of FSH, AMH and the presence of at least one AFC in the ultrasound, the patients are again included in the ovulation stimulation cycle.
Settings and conduct
Shohada Tajrish Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria
Infertile women under the age of 42 with diminished ovarian reserve such as AMH<1ng/ml or AFC<5 and infertile women with poor ovarian response: with a history of recovering less than 5 eggs in IVF
Non-entry criteria
Infertility due to inflammation, endometriosis and PID, hyperandrogenism and PCO, anatomical disorder, male factor, platelet deficiency and bleeding disorders.
Intervention groups
Infertile women due to reduced ovarian reserve
Main outcome variables
ovarian reserve
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160722029027N14
Registration date:2024-01-31, 1402/11/11
Registration timing:registered_while_recruiting
Last update:2024-01-31, 1402/11/11
Update count:0
Registration date
2024-01-31, 1402/11/11
Registrant information
Name
Leila Nazari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8000
Email address
nazari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-01, 1402/10/11
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of intraovarian injection of platelet rich plasma on ovarian reserve in infertile women due to decreased ovarian reserve
Public title
Investigating the effectiveness of intraovarian injection of platelet rich plasma on ovarian reserve in infertile women due to decreased ovarian reserve
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with infertility under 42 years old with diminished ovarian reserve as AMH<1ng/ml or AFC<5
Infertile women with poor ovarian response: with a history of retrieving less than 5 eggs in IVF
Exclusion criteria:
Infertility due to inflammation
Endometriosis and PID
Hyperandrogenism and PCO
Anatomical disorder
Anatomical disorder
Platelet defects
bleeding disorders
Age
From 18 years old to 42 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
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
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Ethics committee of Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-12-31, 1402/10/10
Ethics committee reference number
IR.SBMU.MSP.REC.1402.516
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reduced ovarian reserve: AMH serum level<1ng/ml or AFC<5 in women under 42 years of age
Timepoint
2 months
Method of measurement
In all women included in the study, on the first to third day of menstruation under ultrasound (if there is no follicle above 10 mm and the thickness of the endometrium is below 5 mm and ovulation) and treatment with Pergoveris injectable gonadotropin twice a day, and when the growing follicle reaches 12-14 mm in size, GnRH antagonist (0.25 mg/day cetrotide) will be started subcutaneously. This injection will continue until the day of (ovitrelle (recombinant HCG) (250 micrograms) administration. When the dominant follicle reaches 18 mm, ovulation is induced using (ovitrelle (recombinant HCG (250 micrograms)) and transvaginal oocyte retrieval during 34 to 36 hours after the injection (ovitrelle (recombinant HCG (250 micrograms)) will be performed with ultrasound guidance. On the day of ovulation, after ovarian puncture, 3 cc of PRP injection will be performed. If the IVF cycle fails, on the third Menstrual cycle After checking the serum level of FSH, AMH and the presence of at least one AFC in the ultrasound, the patients are again included in the ovulation stimulation cycle.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In all women included in the study and after collecting background information such as demographic characteristics and records related to previous pregnancy, on the first to third day of menstruation under ultrasound (if there is no follicle above 10 mm and the thickness of the endometrium is below 5 mm and ovulation) and treatment with Pergoveris injectable gonadotropin twice a day, and when the growing follicle reaches 12-14 mm in size, GnRH antagonist (0.25 mg/day cetrotide) will be started subcutaneously. This injection will continue until the day of (ovitrelle (recombinant HCG) (250 micrograms) administration. When the dominant follicle reaches 18 mm, ovulation is induced using (ovitrelle (recombinant HCG (250 micrograms)) and transvaginal oocyte retrieval during 34 to 36 hours after the injection (ovitrelle (recombinant HCG (250 micrograms)) will be performed with ultrasound guidance. On the day of ovulation, after ovarian puncture, 3 cc of PRP injection will be performed. If the IVF cycle fails, on the third Menstrual cycle After checking the serum level of FSH, AMH and the presence of at least one AFC in the ultrasound, the patients are again included in the ovulation stimulation cycle.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان شهدای تجریش
Full name of responsible person
Leila Nazari
Street address
Tehran-Shohada Tajrish Hospital
City
Tehran
Province
Tehran
Postal code
989934148
Phone
+98 21 2271 8000
Email
pr-shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Deputy Research and Technology
Street address
Deputy of Research and Technology of Shahid Beheshti University of Medical Science
City
Tehran
Province
Tehran
Postal code
4631 19395
Phone
+98 21 2243 9781
Email
sec.bms@acecr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Leila Nazari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
4631 19395
Phone
+98 21 2243 9872
Email
nazari@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Leila Nazari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
4631- 19395
Phone
+98 21 2243 9872
Email
nazari@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Leila Nazari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
4631- 19395
Phone
+98 21 2243 9872
Email
nazari@sbmu.ac.ir
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
6 months after the end of the study
When the data will become available and for how long
6 months after the end of the study
To whom data/document is available
6 months after the end of the study
Under which criteria data/document could be used
6 months after the end of the study
From where data/document is obtainable
6 months after the end of the study - project manager
What processes are involved for a request to access data/document
6 months after the end of the study, she can request from the project manager