Menstrual Blood Stem Cells in Poor Ovarian Responders
Condition: Poor Ovarian Response; Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      With economic development, procreation delays have resulted in more women seeking medical
      help for infertility treatment. Because the quality and quantity of oocytes are affected by
      physiological age, despite advances in assisted reproductive technology (ART), managing
      infertility in women with poor ovarian response (POR) remains a daily challenge for
      physicians.

      Adult mesenchymal stromal cell (MSC) therapy has gained particular interest in recent years
      because it may provide a supportive microenvironment for oocyte development from quiescent
      primordial follicles. Human MSC transplantation has been shown in preclinical studies to host
      ovaries and restore their function and structure premature ovarian failure (POF) animal
      models.

      Because of their encouraging characteristics such as ease of access, high availability,
      monthly repeatability of sampling, less ethical considerations, lack of tumor-causing
      potential, protected property, and significant trans-differentiation capacity,
      endometrial-derived stromal cells have been considered in a wide range of studies since 2007.
      Menstrual blood-derived stromal cells (MenSCs), on the other hand, are derived from
      endometrial tissue and can be collected in a non-invasive manner, making them especially
      useful in the treatment of reproductive disorders. The investigators attempted to assess the
      safety and efficacy of intraovarian injection of MenSCs for the treatment of infertility in
      POR patients based on this evidence.

      The results of this clinical trial's phases I and II indicated that Men-MSCs could be
      considered as a potential treatment to restore the fertility capability of POR women. Based
      on these findings, the investigators have designed a Phase III controlled trial of autologous
      MenSC therapy for patients with POR.
    

Intervention name(s): Autologous Menstrual Blood Stem Cells
Intervention type(s): Biological
Intervention description(s): 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
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Poor Ovarian Responders; Menstrual Blood Stem cells; Infertility; Cell therapy; ICSI