Menstrual Blood Stem Cells in Poor Ovarian Responders
- Conditions
- Poor Ovarian ResponseInfertility, Female
- Interventions
- Biological: Autologous Menstrual Blood Stem Cells
- Registration Number
- NCT05703308
- Lead Sponsor
- Avicenna Research Institute
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 180
- 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.
- Positive history of hydrosalpinx or anatomical uterine disorders (In vaginal sonography or HSG)
- Severe male factors of their husbands (count <15 million/ml)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MenSCs group Autologous Menstrual Blood Stem Cells Study group, treated with autologous intra-ovarian MenSCs injection and monitored for spontaneous pregnancy for 3 months after intervention. ICSI was used in cases where the pregnancy did not occur naturally.
- Primary Outcome Measures
Name Time Method Spontaneous pregnancy rate 3 months after stem cell injection Number of participants that establish a spontaneous clinical pregnancy after stem cell injection
Pregnancy rate after ICSI 4 weeks after embryo transfer Number of participants that establish a clinical pregnancy after embryo transfer
- Secondary Outcome Measures
Name Time Method Number of high quality embryos number Day 3-5 after follicle puncture Grade A for cleavage stage embryo, \>=3BB for blastocyst
Biochemical pregnancy rate 12-16 days after oocyte pick-up Incidence of serum beta-hCG test \> 25 mIU/ml
Number of MII oocytes Day 0 after follicle puncture Mean number of metaphase II (MII) oocytes per protocol
Hormone levels 2 and 4 months after stem cell injection Change from baseline in Anti-Müllerian hormone (AMH), serum follicle stimulating hormone (FSH), and antral follicle count (AFC)
Live birth rate at a follow-up time of 30 days after delivery Incidence of the birth of at least one live newborn after 22 weeks of gestation
Number of oocytes Day 0 after follicle puncture Mean number of retrieved COCs per protocol
Clinical pregnancy rate 4 weeks after embryo transfer The incidence of gestational sac with heartbeat assessed by TVS
Number of embryos Day 3-5 after follicle puncture Mean number of embryos
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] at a follow-up time after 1 year Incidence of adverse and serious adverse events with potential relationship to treatment
Trial Locations
- Locations (1)
Avicenna Research Institute
🇮🇷Tehran, Iran, Islamic Republic of