Study the therapeutic effect of Platalet-Rich Plasma (PRP) in treatment of depletion of ovarian reserve in women
Design
Clinical trial without control group, community based, with one group, not blinded, Non-randomised controlled study.
Settings and conduct
This study will be done in Afzalipour hospital infertility center and kerman medical university. After selection of patients by clinician, their blood will be taken and PRP provided. Then PRP will be injected 1 time by clinician and the patients will be followed up for 1 and 6 months after injection
Participants/Inclusion and exclusion criteria
inclusion criteria:
Patients aged between 20-45 years;
Presence of at least one ovary;
Presence of poor ovarian responders criteria including one of the following: Anti Mullerian Hormone <1.1 ng/mL; Antral follicle Count <7 follicles; History of Cancellation of the IVF Cycle due to the lack of follicle growth; IVF history with oocyte count less than 3.
exclusion criteria:
IgA deficiency;
Adhesion or severe damage to the pelvis or ovaries;
Pregnancy;
Anticoagulation therapy;
Opium addiction;
Gynecologic or non gynecologic malignancies;
Individuals with chronic pelvic pain
Intervention groups
30 infertile women aged 20 to 45 who have received a drug for Invitro Fertilization and have inclusion criteria and have not exclusion criteria. At the time of oocyte retrieval platelet-rich plasma injected into the ovaries by a pick up needle.
Main outcome variables
Anti mullerian hormone; antral follicle count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151004024335N4
Registration date:2019-05-20, 1398/02/30
Registration timing:prospective
Last update:2019-05-20, 1398/02/30
Update count:0
Registration date
2019-05-20, 1398/02/30
Registrant information
Name
robabe hoseinisadat
Name of organization / entity
infertility institute center of shahid sadughi
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 7085
Email address
robabehoseini@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of Platalet-Rich Plasma (PRP) in treatment of depletion of ovarian reserve in women
Public title
Study the effect of intra ovarian Platalet-Rich Plasma (PRP) in treatment of depletion of ovarian reserve in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged between 20-45
at least one ovary
poor ovarian responders criteria including one of the following: Anti Mullerian Hormone <1.1 ng/mL; Antral follicle Count <7 follicles; History of Cancellation of the IVF Cycle due to the lack of follicle growth; IVF history with oocyte count less than 3.
Exclusion criteria:
IgA deficiency
adhesion or severe damage to the pelvis or ovaries
pregnancy
anticoagulation therapy
opium addiction
gynecologic or non gynecologic malignancies
chronic pelvic pain
Age
From 20 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
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 comittee of Kerman University of Medical Sciences
Street address
Ibn Sina Street, Jahad Boulevard, Somayeh Road (Tahmasebabad)
City
kerman
Province
Kerman
Postal code
7619813159
Approval date
2019-04-08, 1398/01/19
Ethics committee reference number
IR.KMU.REC.1397.522
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
Anti Mullerian Hormone
Timepoint
Before intervention and 1 and 6 months after intervention
Method of measurement
blood sample
Secondary outcomes
1
Description
Antral follicle count
Timepoint
Before intervention and 1and 6 months after the intervention
Method of measurement
with trans vaginal ultrasonography
Intervention groups
1
Description
Intervention group: 30 infertile women with poor responder ovary criteria. After getting informed consent, own of patient's blood derivatives (Platelet Rich Plasma; PRP) will be used. This product will be injected 1 time to patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Infertility Center
Full name of responsible person
Dr Robabe Hosseinisadat
Street address
Imam Khomeini Highway, Afzalipour Hospital
City
kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8486
Email
robabehosseinisadat@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Research Assistant, Kerman University of Medical Sciences
Street address
Ibn Sina Street, Jahad Boulevard, Somayeh Road (Tahmasebabad)
City
kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3815
Email
robabehosseinisadat@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Robabe Hosseinisadat
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Highway, Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8486
Email
robabehosseinisadat@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Robabe Hosseinisadat
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Highway, Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8486
Email
robabehosseinisadat@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Robabe Hosseinisadat
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Highway, Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8486
Email
robabehosseinisadat@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The final result of the study will be published and there is no need to share individual participants' data
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