Menstrual Blood Stem Cells in Poor Ovarian Responders

Avicenna Research Institute

Status and phase: Completed; Phase 3

Conditions: Poor Ovarian Response; Infertility, Female

Treatments: Biological: Autologous Menstrual Blood Stem Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT05703308

99008-1023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

MenSCs group

Experimental group

Description:

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.

Treatment:

Biological: Autologous Menstrual Blood Stem Cells

ICSI group

No Intervention group

Description:

Control group, monitored for spontaneous pregnancy for 3 months after their last ovarian stimulation for ICSI or IVF. ICSI was used in cases where the pregnancy did not occur naturally.