Protocol summary
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Study aim
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The aim of this study is to compare the effect three treatment methods including gonadotropin, gonadotropin plus intraovarian injection of autologous platelet rich plasma (PRP) and PRP alone on increasing ovarian reserve.
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Design
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In a randomized, not-blinded, phase 2 clinical trial, without control group and using a parallel group design, 45 infertile women with diminished ovarian reserve will randomly assign into three groups of gonadotropin , PRP plus gonadotropin and PRP alone. Randomization will be performed using G power software.
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Settings and conduct
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This study will perform on randomized assigned 3 groups of infertile women with diminished ovarian reserve at Yazd Research and Clinical Center for infertility.
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Participants/Inclusion and exclusion criteria
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Include criteria:
Age 20 to48 years
Diminish ovarian reserve (AMH <1.1 ,AFC<5)
Women with a history of at least one IVF failure
Exclude criteria:
Male factor
Tubal factor
Polycystic Ovarian Syndrome
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Intervention groups
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The patients are Randomly assigned to one of the three groups of
gonadotropin injection, both gonadotropin plus intraovarian injection of PRP ,and intraovarian injection of PRP alone.
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Main outcome variables
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Increasing AMH level; Increasing AFC; Occurrence of spontaneous pregnancy
General information
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Reason for update
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Changing the recruitment start date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151013024512N7
Registration date:
2021-02-11, 1399/11/23
Registration timing:
prospective
Last update:
2021-11-29, 1400/09/08
Update count:
2
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Registration date
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2021-02-11, 1399/11/23
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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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2021-02-15, 1399/11/27
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Expected recruitment end date
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2021-05-04, 1400/02/14
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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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A comparison of the effect of intraovarian injection of autologous platelet rich plasma (PRP) versus PRP plus gonadotropin and gonadotropin alone on ovarian rejuvenation in patients with diminished ovarian reserve
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Public title
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Comparison of the effect of PRP versus PRP plus gonadotropin and gonadotropin alone on ovarian rejuvenation in patients with diminished ovarian reserve
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Female infertility
Diminish ovarian reserve (AMH<1.1 and AFC< 5-7)
20 to 48 years
Exclusion criteria:
Uterin anomaly
Polycystic Ovarian Syndrome
Male factor
Tubal factor
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Age
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From 20 years old to 48 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:
45
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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45 infertile women with diminished ovarian reserve who are referred for infertility treatment will be allocated into three interventional groups via simple, individual randomization method using the table of random numbers. Randomization was previously performed for 45 cases into three groups. This is a not-blinded study. Therefore, the clinician will consecutively assign each woman with the inclusion criteria into one of the three intervention groups for receiving the specific intervention for each group
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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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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-07-19, 1399/04/29
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Ethics committee reference number
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IR.SSU.RSI.REC.1399.025
Health conditions studied
1
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Description of health condition studied
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Ovarian rejuvenation in diminished ovarian reserve patients
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ICD-10 code
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E28.3
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ICD-10 code description
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Primary ovarian failure
Primary outcomes
1
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Description
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Increase Anti-Müllerian hormone level
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Timepoint
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At the beginning of the study, every month up to 3 months
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Method of measurement
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Lab Test
Secondary outcomes
1
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Description
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Antral follicular count
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Timepoint
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1 to 4 months later
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Method of measurement
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Transvaginal sonography
2
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Description
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Spontaneous pregnancy
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Timepoint
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3 months later
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Method of measurement
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Lab test
3
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Description
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Entering assisted reproductive cycle
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Timepoint
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Once the AMH increases or the patient insists on doing assisted reproductive cycle
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Method of measurement
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Lab test
Intervention groups
1
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Description
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Frist intervention group: 15 infertile women with diminished ovarian reserve aged between 20-48 years were administered by gonadotropin (Cinnal f, 75 IU, CinnaGen Co.) with the dose of 75IU, 1 ampule in each ovary between day 10-14 menstrual cycles.
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Category
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Treatment - Drugs
2
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Description
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Second intervention group: 15 infertile women with diminished ovarian reserve aged between 20-48 years were administered by gonadotropin (Cinnal f, 75 IU, CinnaGen Co.) with the dose of 75IU, 1 ampule in each ovary between day 10-14 menstrual cycles PLUS PRP; 17 ml of peripheral venous blood was drawn in the syringe that contained 3 ml of Acid Citrate A Anticoagulant solution (ACD-A) and centrifuged immediately at 1600 g for 10 min. The blood was divided into three layers: red blood cells at the bottom, cellular plasma in the supernatant and a buffy coat layer between them. The plasma layer and buffy coat were collected to another tube and centrifuged again at 3500 g for 5 min to obtain 3 ml PRP
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Category
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Treatment - Drugs
3
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Description
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Intervention group: Third intervention group: 15 infertile women with diminished ovarian reserve aged between 20-48 years were administered PRP alone; 17 ml of peripheral venous blood was drawn in the syringe that contained 3 ml of Acid Citrate A Anticoagulant solution (ACD-A) and centrifuged immediately at 1600 g for 10 min. The blood was divided into three layers: red blood cells at the bottom, cellular plasma in the supernatant and a buffy coat layer between them. The plasma layer and buffy coat were collected to another tube and centrifuged again at 3500 g for 5 min to obtain 3 ml PRP
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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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Deputy of Research and Development, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
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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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There is no more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available