Study the effect of Autologous Platelet-Rich Plasma (PRP) on ovarian function in patients with premature ovarian failure and poor ovarian reserve
Design
Clinical trial with 20 patient in two intervention group without control group and outcome assesment
Settings and conduct
Infertile women refer to reproductive science institute
At first check level of E2, FSH, LH and AMH then injection of PRP into ovary under sedation and vaginal sonography (1.5 cc for each ovary).Recheck level of E2, FSH, LH and AMH monthly
Participants/Inclusion and exclusion criteria
Patient with premature ovarian failure
patient with poor ovarian reserve (AFC<5-7 and AMH<0.5-1.1 ng/ml;
IgA deficiency
Ovarian failure secondary to sex chromosome abnormality Pelvic adhesion scondary to abdominal surgery
Chronic pelvic pain
Intervention groups
Study the effect of Autologous Platelet-Rich Plasma (PRP) on ovarian function in patients with premature ovarian failure and poor ovarian reserve
Main outcome variables
FSH level, AMH level, LH level, Estradiol level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180818040828N2
Registration date:2018-11-22, 1397/09/01
Registration timing:registered_while_recruiting
Last update:2018-11-22, 1397/09/01
Update count:2
Registration date
2018-11-22, 1397/09/01
Registrant information
Name
Lida Saeed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 8000
Email address
lsaeid@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Autologous Platelet-Rich Plasma (PRP) on ovarian function in patients with premature ovarian failure and poor ovarian reserve
Public title
The effect of Autologous Platelet-Rich Plasma (PRP) on ovarian function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with premature ovarian failure
patient with poor ovarian reserve (AFC<5-7 and AMH<0.5-1.1 ng/ml)
Exclusion criteria:
IgA deficiency
Ovarian failure secondary to sex chromosome abnormality
Pelvic adhesion scondary to abdominal surgery
Chronic pelvic pain
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
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
Other
Other design features
This study consider two different groups (POF and poor ovarian reserve) and we do one similar procedure (injection of PRP in ovary) for them and study two group separately
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of reproductive science institute-Yazd Shahid Sadoughi University of Medical Scince
Street address
Bouali Ave, Safaeih
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2018-07-21, 1397/04/30
Ethics committee reference number
IR.SSU.RSI.REC.1397.004
Health conditions studied
1
Description of health condition studied
Premature ovarian failure
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
2
Description of health condition studied
Poor ovarian responders
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
FSH level
Timepoint
Some days before injection and 1, 2 and 3 month after injection
Method of measurement
Check in labratory
2
Description
AMH level
Timepoint
Some days before injection and 1, 2 and 3 month after injection
Method of measurement
Check in labratory
3
Description
Estradiol level
Timepoint
Some days before injection and 1, 2 and 3 month after injection
Method of measurement
Check in labratory
4
Description
LH level
Timepoint
Some days before injection and 1, 2 and 3 month after injection
Method of measurement
Check in labratory
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: At first test serum AMH, estradiol(E2), FSH and LH a few days before intervention.In intervention day PRP process with Rooyagen kit.Approximately, 8.5 ml collect from each patient.Sample place in room-temperature centrifuge set to 1600*g for 10 minute.Finally 1.5-2 ml PRP with 4-5 fold concentration and 2000 lymphocyte is ready and for activation add calcium gluconate to it.PRP injection into ovareis under sedation and transvaginal sonography guidance is done (1.5ml for each ovary).Then for outcome assesment serum AMM, estradiol(E2), FSH and LH test every month.
Category
Treatment - Drugs
2
Description
Second intervention group: At first test serum AMH, estradiol(E2), FSH and LH a few days before intervention.In intervention day PRP process with Rooyagen kit.Approximately, 8.5 ml collect from each patient.Sample place in room-temperature centrifuge set to 1600*g for 10 minute.Finally 1.5-2 ml PRP with 4-5 fold concentration and 2000 lymphocyte is ready and for activation add calcium gluconate to it.PRP injection into ovareis under sedation and transvaginal sonography guidance is done (1.5ml for each ovary).Then for outcome assesment serum AMM, estradiol(E2), FSH and LH test every month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd reproductive science institute
Full name of responsible person
Dr. Abbas aflatoonian
Street address
Bouali Ave, Safaeih
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
abbas_aflatoonian@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Masoud Mirzaei
Street address
Bahonar Square, Yazd University of Medical Sceince
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3724 0171
Email
Masoudmirzaei@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr.Lida Saeed
Position
Assistant professor, Infertility fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali Ave, Safaeih
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
lsaeed6@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Abbas Aflatoonian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Reproductive Science Institute, Bouali Ave, Safaeih
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
abbas_aflatoonian@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Lida Saeed
Position
Assistant Professor, Infertility Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Reproductive Science Institute, Booali Ave, Safaeih
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
lsaeed6@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
Due to the privacy of patients
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
Study protocol, statistical analysis map, clinical study report after article edition will bw available
When the data will become available and for how long
After article edition
To whom data/document is available
Researchers that work in university
Under which criteria data/document could be used
In retrospective studies
From where data/document is obtainable
Yazd reproductive sciences institute
What processes are involved for a request to access data/document
Demand from Vice president of reseaech, propound in Research council to infertility center and after acception refer to research expert and receive the data