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Clinical trial

Outcome of Pregnancy in Poor Ovarian Responders by Intraovarian Administration of Autologous Menstrual Blood Derived-Mesenchymal Stromal Cells

ID
Name
99008-1023
Description
In this controlled trial, poor ovarian responder women will be treated with transplantation of autologous menstrual blood stem cells. The investigators will attempt to assess the safety and efficacy of this procedure for the treatment of infertility in POR patients compared to control group.
Trial arms
Trial start
2020-06-21
Estimated PCD
2021-09-22
Trial end
2022-10-22
Status
Completed
Phase
Early phase I
Treatment
Autologous Menstrual Blood Stem Cells
The menstrual blood of patients in the MenSCs treatment group was collected in sterile menstrual cups on the second day of menstruation, and directly transferred to a class B clean room for MSC isolation and culture. All cell quality control studies were performed prior to the International Conference of Harmonization Q2 (ICH Q2) guidelines. The density of the final product was 20×106 cells/ml. 150 μl of the prepared suspension was injected intravaginally into each ovary of the patient under general anaesthesia
Arms:
MenSCs group
Size
180
Primary endpoint
Spontaneous pregnancy rate
3 months after stem cell injection
Pregnancy rate after ICSI
4 weeks after embryo transfer
Eligibility criteria
Inclusion Criteria: * Serum AMH \< 0.1 ng/ml (at the screening visit and in the absence of OC or sex-steroid intake) * Antral follicular count (AFC) in both ovaries \< 4 (at screening visit and in the absence of OC or sex-steroid intake) * Positive history of at least1 standard previous IVF-ET or ICSI-ET * Normal thyroid hormones (TSH and FT4) * Normal level of prolactin, * Normal level of fasting blood sugar * Normal Liver tests (SGOT, SGPT) * Normal level of BUN, creatinine * Negative Infectious tests (HIV, HCV, HBS Ag, VDRL) * Normal coagulation factors (PT, PTT, BT, CT) * Normal serum levels of sodium, potassium, calcium, phosphorus * Negative history of endometrioma or other ovarian cysts * Negative history of previous ovarian surgery * Negative history of cancer * Negative history of a known autoimmune disorder. Exclusion Criteria: * Positive history of hydrosalpinx or anatomical uterine disorders (In vaginal sonography or HSG) * Severe male factors of their husbands (count \<15 million/ml)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 180, 'type': 'ACTUAL'}}
Updated at
2023-01-30

1 organization

1 product

3 indications

Organization
Avicenna Research Institute
Product
Autologous Menstrual Blood Stem Cells
Indication
Diminished Ovarian Reserve
Indication
infertility
Indication
Woman