Protocol summary
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Study aim
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Improvement of ovarian function and fertility in patients with poor ovarian response using stem cells derived from menstrual blood
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Design
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Clinical trial including control group, two arm parallel group, randomised trial
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Settings and conduct
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The entire population is selected according to the inclusion and exclusion criteria and all patients must sign the informed consent. The subjects are randomly divided into intervention and control groups. Menstrual blood is collected from the patients of the intervention group at days 1 or 2 of their menstruation cycle using menstrual cups. Stem cells are isolated from collected menstrual blood and cultured in vitro. Cultured cells are evaluated for phenotyping and non-contamination. Autologous cells are administered to the ovary of patients in Avicenna Infertility Treatment Center.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: married woman;having previous cycles of ovarian stimulation with oocyte number of up to 3;anti-muller hormone below 1.1 ng/ml; antral follicle below 5; up to 40 years
Sperm analysis:more than 5 million per ml; normal morphology with the strict criterion of at least 1%;25% of sperm motility
Exclusion criteria: Thyroid dysfunction; Immune system disease; History of cancer; Hepatitis B and C and HIV; Endometriosis; Ovarian surgery; Diabetes; Liver dysfunction
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Intervention groups
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Intervention group: patients with reduced ovarian function are treated by stem cell infusion
Control group: patients with reduced ovarian function are considered with no intervention only to compare their status with the intervention group
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Main outcome variables
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Number of antral follicles,
Anti Mullerian hormone levels,
Number and quality of oocytes in the treatment cycle,
Number and quality of the embryos,
Spontaneous pregnancy,
Clinical pregnancy,
Implantation rate,
Live birth rate
General information
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Reason for update
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Methodology revision during project implementation
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180619040147N2
Registration date:
2018-08-21, 1397/05/30
Registration timing:
registered_while_recruiting
Last update:
2020-03-25, 1399/01/06
Update count:
4
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Registration date
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2018-08-21, 1397/05/30
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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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2018-08-06, 1397/05/15
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Expected recruitment end date
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2019-10-07, 1398/07/15
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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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Evaluation of the safety and feasibility of intra ovarian injection of menstrual blood derived stem cells (MenSCs) in women with poor ovarian response.
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Public title
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Evaluation of the safety and feasibility of intra ovarian injection of menstrual blood derived stem cells (MenSCs) in women with poor ovarian response.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Got married woman
Picked up less than 3 oocytes in last ovarian stimulation
Anti mullerian hormone; less than 1.1 ng/ml
Upper age limit: 40
Spermogram: more than 5 million/ml, normal morphology more than 1, sperm motility (A+B) more than 25%
Anteral follicles: less than 5-7
Exclusion criteria:
Thyroid dysfunction
Immune disorders
History of cancer, chemotherapy and radiotherapy
Infected by hepatitis B,C or HIV
Severe endometriosis
History of ovarian surgery
Diabetes
Dysfunction of electrolyte or liver tests
Psychological problem like depression, high stress an anxiety
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Age
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From 25 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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1-2
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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:
36
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization: In order to randomly assign 36 subjects in treatment group or control group, 6 blocks including 6 subjects each will be defined using "https://app.studyrandomizer.com". Treatment group and control group will be identified by codes A and B, respectively. In each block, number of treatment group and control group is equal and situation of each block with other block is different.
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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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2018-05-06, 1397/02/16
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Ethics committee reference number
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IR.ACECR.REC.1397.001
Health conditions studied
1
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Description of health condition studied
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Poor ovarian response
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ICD-10 code
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E89.40
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ICD-10 code description
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Asymptomatic postprocedural ovarian failure
Primary outcomes
1
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Description
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Number of antral follicles in ovary
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Timepoint
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Before intervention, 3 months and 6 months after cell administration
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Method of measurement
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Vaginal sonography
2
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Description
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Anti Mullerian hormone level in blood serum
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Timepoint
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Before intervention, 3 months, 6 months and one year after cell administration
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Method of measurement
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biochemical assay
3
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Description
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number and quality of oocytes in intra-cytoplasmic sperm injection cycle
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Timepoint
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first intra-cytoplasmic sperm injection cycle after intervention
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Method of measurement
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embryologic evaluation
4
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Description
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spontaneous pregnancy
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Timepoint
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up to 3 months after intervention
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Method of measurement
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beta-HCG assay
Secondary outcomes
1
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Description
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Implantation rate
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Timepoint
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in new intra-cytoplasmic sperm injection cycle after intervention
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Method of measurement
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Vaginal sonography
2
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Description
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Clinical pregnancy
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Timepoint
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6-8 weeks after last menstrual period
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Method of measurement
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Vaginal sonography
3
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Description
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live birth
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Timepoint
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9 months after pregnancy
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Method of measurement
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delivery report based on gynecologist comment
4
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Description
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embryo quality and number
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Timepoint
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in new intra-cytoplasmic sperm injection cycle after intervention
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Method of measurement
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embryology report
Intervention groups
1
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Description
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Intervention group: includes 18 patients with poor ovarian response that will be treated by once injection of autologous menstrual blood stem cells. After cells isolation, culture and qualification in GMP grade- clean room of STERCO (Tehran, Iran), they will be intravaginally injected by vaginal ultrasonography into left ovary of patients after receiving general anesthesia.
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Category
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Treatment - Other
2
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Description
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Control group: includes 18 patients with poor ovarian response that will not receive any intervention and their biochemical parameters, sonographic and embryologic data will be compared with intervention group.
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Category
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Treatment - Other
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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Iranian Academic Center for Education Culture and Research
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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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Other
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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No - There is not 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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Not applicable
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Data Dictionary
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Not applicable