Protocol summary
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Study aim
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Study the effect of Autologous Platelet-Rich Plasma (PRP) on ovarian function in patients with premature ovarian failure and poor ovarian reserve
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Design
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Clinical trial with 30 patient in two intervention group without control group and outcome assessment
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Settings and conduct
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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 (2-4 cc for both ovaries) two times with 90 days interval .Recheck level of E2, FSH, LH and AMH monthly for two consecutive months between the two PRP injections.
Follow up patients for possible spontaneous pregnancy
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Intervention in two groups of premature ovarian failure and poor ovarian reserve.
At first check level of E2, FSH, LH and AMH then injection of PRP into ovary under sedation and vaginal sonography (2-4 cc for both ovaries) .Recheck level of E2, FSH, LH and AMH monthly for two consecutive months and then the second PRP injection 90 days after the first one.
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Main outcome variables
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FSH level, AMH level, LH level, Estradiol level
General information
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Reason for update
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As the number of both POF patients and poor responders who were referred to Yazd Infertility Center was more than the first estimation, and based on patients' insistence for receiving the new treatment method of PRP injection, we aimed to increase the number of study cases.
Due to the decline and elevation of hormones levels in comparison with the baseline measurements and also spontaneous pregnancy occurrence in the first month after the first PRP injection, the interval between the first and the second PRP injections was extended to 90 days. All patients were followed up for possible spontaneous pregnancy until live birth. Finally the duration of study including recruiting and follow up was extended.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180818040828N2
Registration date:
2018-11-22, 1397/09/01
Registration timing:
registered_while_recruiting
Last update:
2021-02-28, 1399/12/10
Update count:
2
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Registration date
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2018-11-22, 1397/09/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-09-01, 1397/06/10
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Expected recruitment end date
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2020-03-01, 1398/12/11
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of Autologous Platelet-Rich Plasma (PRP) on ovarian function in patients with premature ovarian failure and poor ovarian reserve
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Public title
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The effect of Autologous Platelet-Rich Plasma (PRP) on ovarian function
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 42 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Other
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Other design features
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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
Ethics committees
1
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Ethics committee
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Approval date
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2018-07-21, 1397/04/30
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Ethics committee reference number
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IR.SSU.RSI.REC.1397.004
Health conditions studied
1
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Description of health condition studied
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Premature ovarian failure
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ICD-10 code
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N97.0
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ICD-10 code description
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Female infertility associated with anovulation
2
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Description of health condition studied
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Poor ovarian responders
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ICD-10 code
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N97.0
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ICD-10 code description
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Female infertility associated with anovulation
Primary outcomes
1
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Description
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FSH level
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Timepoint
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Some days before injection and 1, 2 months after injection
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Method of measurement
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Check in labratory
2
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Description
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AMH level
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Timepoint
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Some days before injection and 1, 2 months after injection
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Method of measurement
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Check in labratory
3
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Description
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Estradiol level
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Timepoint
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Some days before injection and 1, 2 months after injection
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Method of measurement
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Check in labratory
4
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Description
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LH level
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Timepoint
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Some days before injection and 1, 2 months after injection
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Method of measurement
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Check in labratory
Secondary outcomes
1
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Description
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Chemical pregnancy
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Timepoint
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1 year after the first PRP injection
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Method of measurement
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Laboratory measurement of Beta hCG
2
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Description
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Clinical pregnancy
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Timepoint
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5 weeks after positive Beta hCG
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Method of measurement
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Observation of fetal heart rate in sonography
3
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Description
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Live birth
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Timepoint
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36 weeks after positive Beta hCG
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Method of measurement
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Delivery of live-born baby
Intervention groups
1
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Description
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First intervention group(premature ovarian failure): 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 (2-4 ml for both ovaries) and serum AMM, estradiol(E2), FSH and LH test every month is measured for two consecutive months.90 days later the second PRP injection is done. 1-year follow up of patients for possible spontaneous regency.
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Category
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Treatment - Drugs
2
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Description
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Second intervention group (poor ovarian response): 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 (2-4 ml for both ovaries) and serum AMM, estradiol(E2), FSH and LH test every month is measured for two consecutive months.90 days later the second PRP injection is done. 1-year follow up of patients for possible spontaneous regency.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yazd University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Due to the privacy of patients
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Study protocol, statistical analysis map, clinical study report after article edition will bw available
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When the data will become available and for how long
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After article edition
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To whom data/document is available
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Researchers that work in university
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Under which criteria data/document could be used
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In retrospective studies
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From where data/document is obtainable
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Yazd reproductive sciences institute
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What processes are involved for a request to access data/document
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Demand from Vice president of reseaech, propound in Research council to infertility center and after acception refer to research expert and receive the data
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Comments
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