Protocol summary
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Study aim
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To assess the effect of infertility treatment with and without addition of autologous platelet-rich plasma in embryo transfer in patients candidate for intra cytoplasmic sperm injection
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Design
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This is a randomized clinical trial, phase II, in which 56 eligible patients will be randomly assigned to the intervention and control groups
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Settings and conduct
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The eligible patients candidate for intra cytoplasmic sperm injection who will refer to Fatemieh Hospital during the study period will be enrolled in the trial
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age of 20 to 40 years;
Candidate for embryo transfer;
Having at least two embryos of good quality to transfer;
Having a healthy uterus cavity
Exclusion criteria:
Patients in need of sperm donation;
Patients in need of ovum donation;
Previous history of embryo transfer;
Endocrine diseases such as hyperthyroidism, hypothyroidism, hyperprolactinemia, diabetes
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Intervention groups
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Intervention group: Routine infertility treatment plus injection of autologous platelet-rich plasma 20% once
Control group: Just routine infertility treatment
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Main outcome variables
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Primary outcome:
Chemical pregnancy
Clinical pregnancy
Seeing fetal heart sonography
Secondary outcome:
Abortion
General information
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Reason for update
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This study was implemented later than the time predicted in the project. The only place that needs to change is the start and end time of the study.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120215009014N230
Registration date:
2018-08-24, 1397/06/02
Registration timing:
prospective
Last update:
2024-11-20, 1403/08/30
Update count:
1
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Registration date
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2018-08-24, 1397/06/02
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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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2022-09-23, 1401/07/01
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Expected recruitment end date
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2023-09-23, 1402/07/01
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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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Effect of infertility treatment with and without addition of autologous platelet-rich plasma in embryo transfer in patients candidate for intra cytoplasmic sperm injection: a randomized clinical trial
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Public title
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Effect of infertility treatment with and without addition of autologous platelet-rich plasma in embryo transfer in patients candidate for intra cytoplasmic sperm injection
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age of 20 to 40 years;
Candidate for embryo transfer;
Having at least two embryos of good quality to transfer;
Having a healthy uterus cavity
Exclusion criteria:
Patients in need of sperm donation;
Patients in need of ovum donation;
Previous history of embryo transfer;
Endocrine diseases such as hyperthyroidism, hypothyroidism, hyperprolactinemia, diabetes
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Age
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From 20 years old to 40 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:
56
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The patients will be randomly assigned to intervention and control groups using block randomization
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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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2018-06-30, 1397/04/09
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Ethics committee reference number
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IR.UMSHA.REC.1397.235
Health conditions studied
1
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Description of health condition studied
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Female infertility
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ICD-10 code
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N97
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ICD-10 code description
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Female infertility
Primary outcomes
1
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Description
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Chemical pregnancy
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Timepoint
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14 days after intervention
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Method of measurement
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Through laboratory test
2
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Description
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Clinical pregnancy
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Timepoint
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21 days after intervention
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Method of measurement
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By sonography
3
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Description
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Seeing fetal heart
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Timepoint
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28 days after intervention
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Method of measurement
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By sonography
Secondary outcomes
1
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Description
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Abortion
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Timepoint
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28 days after intervention
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Method of measurement
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Through history taking
Intervention groups
1
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Description
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Intervention group: Routine infertility treatment plus injection of autologous platelet-rich plasma 20% once
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Category
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Treatment - Drugs
2
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Description
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Control group: Just routine infertility treatment
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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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Hamedan 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available