Protocol summary
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Study aim
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Increased ovarian function and fertility in early menopausal patients (POF) using stem cells derived from menstrual blood
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Design
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The study will be done as clinical trail such the ovarian function of POF patients after cell therapy using menstrual blood stem cells in case group will be compared to that of control group without intervention. The selection will be done as nonrandomized. The number of patients in each group will be 15.
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Settings and conduct
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The eligible patients will study and sign the inform consent. After randomization these women will be divided into case or control group and the phases 1 and 2 of clinical trial will be started. The menstrual blood will be collected using divacup at day 1 or 2 of menstruation and stem cells will be
isolated cultured and assessed in aspect of phenotype and no contamination in clean room of Avicenna Research Institute. The autologous cultured cells will be administrated into ovary of
patients in Avicenna infertility Clinic.
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Participants/Inclusion and exclusion criteria
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1 - married woman 2 - over 20 and under 40 years 3 - normal karyotype 4 - premature ovarian failure and the amount of follicle stimulating hormone greater than 20 IU / ml and anti-muller hormone below 1 ng / ml 5-sperm analysis at least 15 million per ml Sperm and normal morphology 2% and spermatozoa (A + B) above 25%
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Intervention groups
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1-Thyroid deficiency 2- Immune system disease 3- Cancer history and chemotherapy and radiation therapy 4. Hepatitis B and C virus infection and HIV 5- Endometriosis Severe 6. History of ovarian surgery 7- Diabetes 8. Test disorder Electrolyte or liver
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Main outcome variables
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number and size of anteral follicles, FSH and LH levels, Anti Mullerian hormone (ATH) level, ovary size, menstruation
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180619040147N1
Registration date:
2018-08-20, 1397/05/29
Registration timing:
registered_while_recruiting
Last update:
2020-01-16, 1398/10/26
Update count:
2
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Registration date
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2018-08-20, 1397/05/29
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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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2018-07-11, 1397/04/20
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Expected recruitment end date
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2019-06-22, 1398/04/01
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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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Evaluation of the safety and feasibility of infra ovarian injection of menstrual blood derived stem cells (MenSCs) in women with premature ovarian failure
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Public title
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Evaluation of the safety and feasibility of infra ovarian injection of menstrual blood derived stem cells (MenSCs) in women with premature ovarian failure
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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
normal karyotype
FSH more than 20 IU/ml
anti mullerian hormone; less than 1 ng/ml
spermogram: more than 15 million/ml, normal morphology more than 2%, sperm motility (A+B) morethan 25%anteral follicles: less than 5
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 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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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:
30
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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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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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premature ovarian failure
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ICD-10 code
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E28.31
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ICD-10 code description
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Premature menopause
Primary outcomes
1
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Description
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number and diameter of anteral follicles, FSH level, AMH level, ovary volume, menstruation
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Timepoint
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3 months, 6 months and one year after cell administration
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Method of measurement
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sonography, embryologic evaluation, biochemical assays
Intervention groups
1
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Description
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Intervention group includes 15 patients with premature ovarian failure that will be treated by stem cell injection.
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Category
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Treatment - Other
2
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Description
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Control group: includes 15 patients with premature ovarian failure 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