Protocol summary
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Study aim
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Evaluation of the effect of PRP on ovarian function in patients with poor ovarian response.
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Design
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A non-randomized clinical trial with Control group; In parallel, Phase 4 will be performed on 44 infertile women with ovarian poor response and IVF candidates.
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Settings and conduct
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Infertile women referring to Valiasr Infertility Clinic of Imam Khomeini Hospital Complex of Tehran University of Medical Sciences will be selected in two groups of intervention (A) and control (B) with non-random conditions. In all patients, ovarian stimulation is initiated according to the antagonist protocol and in the intervention group, immediately after the follicle reaches 17 mm, 2 cc of enriched platelet (PRP) is injected into each ovary under anesthesia, and then the steps IVF is performed. PRP is not performed in the control group and they receive routine ovarian stimulation treatments.
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Participants/Inclusion and exclusion criteria
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Infertile women with poor ovarian function; Antimullerian hormone between 0.5-1.1 and the presence of at least ten million sperm with 3% of normal morphology are included in the study. Underlying diseases; Chromosomal abnormalities and hemoglobin less than 11 g / dL are not included in the study.
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Intervention groups
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Intervention group: After stimulation of the ovary and immediately after the follicle reaches 17 mm, 2 cc of enriched platelet (PRP) is injected into each ovary under anesthesia at the same time as the puncture. In the control group, PRP is not performed and routine ovarian stimulation is performed.
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Main outcome variables
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The number of eggs grown and the level of the antimullerian hormone are the main outcomes and chemical pregnancy and clinical pregnancy are the secondary outcomes of the study.
General information
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Reason for update
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Setting primary and secondary outcomes; Set the exact study time; Set study inclusion and exclusion criteria.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20141217020351N11
Registration date:
2020-11-25, 1399/09/05
Registration timing:
registered_while_recruiting
Last update:
2022-01-01, 1400/10/11
Update count:
2
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Registration date
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2020-11-25, 1399/09/05
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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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2020-10-01, 1399/07/10
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Expected recruitment end date
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2021-08-31, 1400/06/09
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Actual recruitment start date
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2020-10-01, 1399/07/10
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Actual recruitment end date
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2021-04-19, 1400/01/30
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Trial completion date
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2021-06-20, 1400/03/30
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Scientific title
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The effect of platelet-rich plasma injection in the ovary on the number of oocytes; Oocyte quality and antimullerian hormone in cases of poor ovarian Responses.
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Public title
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The effect of plasma injection in the ovary on the number of Follicle and oocytes, the quality of oocytes, and Anti Mullerian hormone in cases of poor 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:
The second cycle of embryo transfer
Criteria for detecting poor ovarian function based on the Bologna criterion
Age less than 45 years
History of having at least three oocytes in the previous cycle
AMH hormone less than 1.1 ng / ml
BMI less than 30kg/m2
At least ten million sperm and three percent sperm with a normal morphology
Exclusion criteria:
Immunological diseases
Hematological diseases
Chromosomal or genetic disorder
Uterine disorders
Hemoglobin level less than 11 grams per deciliter
Platelets less than one hundred and fifty thousand per cubic millimeter
Systemic use of corticosteroids within two weeks before the procedure
Hypothyroidism
Respiratory tract infections
Kidney failure
Endometriosis
Sub mucusal myoma
Asherman Syndrome
Pathology of the Fallopian tubes (Hydrosalpinx)
Endocrine diseases
Endocrine diseases
Allergic reactions
The dissatisfaction of the patient to continue treatment
No contraindications for pregnancy
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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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4
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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:
44
Actual sample size reached:
45
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Randomization (investigator's opinion)
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Not randomized
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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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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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2020-09-30, 1399/07/09
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Ethics committee reference number
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IR.TUMS.IKHC.REC.1399.271
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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Number of oocyte
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Timepoint
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Two months after the PRP
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Method of measurement
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Vaginal Sonography
2
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Description
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Antimullerian hormone
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Timepoint
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Two months after the PRP
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Method of measurement
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Blood Test
3
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Description
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The quality of oocyte
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Timepoint
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Two months after the PRP
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Method of measurement
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Vaginal Sonography
Secondary outcomes
1
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Description
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Number of obtained of embryo
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Timepoint
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Two months after the PRP
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Method of measurement
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Embryologist diagnosis
2
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Description
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The quality of resulted embryo
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Timepoint
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Two months after the PRP
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Method of measurement
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Embryologist diagnosis
3
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Description
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Chemical Pregnancy
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Timepoint
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Two weeks after the embryo transfer
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Method of measurement
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Blood Test
Intervention groups
1
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Description
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Intervention group:In all patients, ovarian stimulation is initiated according to the antagonist protocol and immediately after the follicle reaches 17 mm at the same time as oocyte removal; 2 cc of enriched platelet solution (PRP) is injected into each ovary under anesthesia and then IVF steps are performed.
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Category
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Treatment - Drugs
2
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Description
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Control group: In this group, PRP is not performed and only routine ovarian stimulation treatments are performed.
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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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No
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Title of funding source
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Vice Chancellor for Research of Tehran 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