Evaluation of the effect of intraovarian platelet rich plasma injection on ovarian folliculogenesis and intracytoplasmic sperm injection outcome in poor responders- Quasi-Experimental Study
The purpose of this study is to investigate the effectiveness of intraovarian platelet-rich plasma injection on ovarian folliculogenesis and the results of intracytoplasmic sperm injection.
Design
In Quasi-Experimental study with a before-and-after design, 20 patients with poor ovarian response will be enrolled in a single group in the period of 2024-2025 at Mehr medical Institute. Blinding and randomization are not valid in this study.
Settings and conduct
The present study will be conducted at Mehr Medical Institute. Pituitary suppression will be done using the agonist method. Ovarian follicles will be obtained using vaginal ultrasound.
Platelet rich plasma will be prepared according to the instructions. After oocyte retrival, 1.5 ml of PRP will be injected into each ovary using a G17, 35 cm single lumen needle and guided by ultrasound.
In the third menstrual cycle after PRP treatment, all participants will receive the GnRH agonist protocol and undergo a second cycle of ICSI.
Participants/Inclusion and exclusion criteria
Patients with poor ovarian reserve
Inclusion criteria:
Age less than 40 years-
The number of antral follicles less than 5-
Anti-Müllerian hormone level less than 0.3 nano-grams/milliliter-
Exclusion criteria:
Women with autoimmune disorders-
Anemia-
Thrombophilic disorders-
Current cancer or medical history of cancer-
Severe male infertility-
Endometriosis
Intervention groups
After oocyte retrieval, 1.5 ml of platelet-rich plasma will be injected into each ovary under ultrasound guidance.
Main outcome variables
The total number of oocytes retrieved-
The total number of metaphase II oocytes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180528039878N5
Registration date:2024-03-04, 1402/12/14
Registration timing:prospective
Last update:2024-03-04, 1402/12/14
Update count:0
Registration date
2024-03-04, 1402/12/14
Registrant information
Name
Marzieh Mehrafza
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3376 4270
Email address
dr.Mehrafza@mehrinstitute.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2025-08-23, 1404/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of intraovarian platelet rich plasma injection on ovarian folliculogenesis and intracytoplasmic sperm injection outcome in poor responders- Quasi-Experimental Study
Public title
PRP effect on ovary
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 40 years
The number of antral follicles is less than 5
Anti-Müllerian hormone level less than 0.3 nano-grams/milliliter
Exclusion criteria:
Women with autoimmune disorders
Anemia
Thrombophilic disorders
Current cancer or medical history of cancer
Severe male infertility
Endometriosis
Age
From 18 years old to 40 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
Ethics Committee of Guilan University of Medical Sciences
Street address
Mehr Medical Institute, Irshad St, Shahid Ansari BLvd, Rasht
City
Rasht
Province
Guilan
Postal code
417861311
Approval date
2024-02-14, 1402/11/25
Ethics committee reference number
IR.GUMS.REC.1402.584
Health conditions studied
1
Description of health condition studied
Primary ovarian failure
ICD-10 code
E28.3
ICD-10 code description
Primary ovarian failure
Primary outcomes
1
Description
The total number of oocytes retrieved
Timepoint
The day of ovarian puncture before platelet rich plasma injection, The day of ovarian puncture after platelet rich plasma injection
Method of measurement
According to the count
2
Description
The total number of metaphase II oocytes
Timepoint
The day of ovarian puncture before platelet rich plasma injection, The day of ovarian puncture after platelet rich plasma injection
Method of measurement
According to the count
Secondary outcomes
1
Description
Basal level of Anti-Müllerian Hormone
Timepoint
Serum level on the third day of the menstrual cycle before platelet-rich plasma injection, Serum level on the third day of the menstrual cycle after platelet-rich plasma injection
Method of measurement
Using the test kit
2
Description
Number of embryos
Timepoint
In the cycle before platelet-rich plasma injection, In the cycle after platelet-rich plasma injection
Method of measurement
According to the count
Intervention groups
1
Description
Intervention group: Intraovarian injection of platelet-rich plasma - 8.5 ml of peripheral venous blood will be drawn into a 10 ml syringe containing 1.5 ml of anticoagulant solution. According to the instructions of the kit (Royagen, Iran), 3 ml of lympho-plasma platelet-rich with a platelet concentration 4 to 5 times higher than the base blood and 2000 lymphocytes per microliter will be prepared.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehr Medical Institute
Full name of responsible person
Marzieh Mehrafza
Street address
Mehr Medical Institute, Irshad St., Shahid Ansari Blvd
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Fax
+98 13 3375 4257
Email
marzieh.mehrafza@gmail.com
Web page address
http://www.mehrinstitute.org/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mehr Medical Institute
Full name of responsible person
Marzieh Mehrafza
Street address
Mehr Medical Institute, Irshad St., Shahid Ansari Blvd
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Fax
+98 13 3375 4257
Email
marzieh.mehrafza@gmail.com
Web page address
http://www.mehrinstitute.org/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mehr Medical Institute
Proportion provided by this source
100
Public or private sector
Private
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
Mehr Medical Institute
Full name of responsible person
Marzieh Mehrafza
Position
Non-faculty subspesialist M.D
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mehr Medical Institute, Irshad St., Shahid Ansari Blvd
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Fax
+98 13 3375 4257
Email
marzieh.mehrafza@gmail.com
Web page address
http://www.mehrinstitute.org/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mehr Medical Institute
Full name of responsible person
Marzieh Mehrafza
Position
Non-faculty subspesialist M.D
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mehr Medical Institute, Irshad St., Shahid Ansari Blvd
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Fax
+98 13 3375 4257
Email
marzieh.mehrafza@gmail.com
Web page address
http://www.mehrinstitute.org/
Person responsible for updating data
Contact
Name of organization / entity
Mehr Medical Institute
Full name of responsible person
Marzieh Mehrafza
Position
Non-faculty subspesialist M.D
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mehr Medical Institute, Irshad St., Shahid Ansari Blvd
City
Rasht
Province
Guilan
Postal code
4178613111
Phone
+98 13 3376 4270
Fax
+98 13 3375 4257
Email
marzieh.mehrafza@gmail.com
Web page address
http://www.mehrinstitute.org/
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
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available