Phase III Study of MediReg Injection for Treating Severe Male Infertility Evaluating Safety, Tolerability, and Effectiveness in Men with Severe Spermatogenesis Disorders

What this Trial Is About

Researchers are evaluating a new treatment for men with severe infertility caused by problems with sperm production, including conditions like non-obstructive azoospermia and severe oligoasthenoteratozoospermia OAT. This Phase III clinical trial aims to study the safety and effectiveness of MediReg4, an innovative drug made from human mesenchymal stromal cell secretions. The study is conducted at Lomonosov Moscow State University and approved by the Ministry of Health of the Russian Federation. It includes men aged 21 to 60 years who have struggled to conceive for at least 12 months despite treatments, including assisted reproductive technologies. The study involves two main treatment groups. One group receives a single injection of 0.5 ml MediReg4 under the membrane of both testicles alternately. Another group receives a combination of clomiphene Clostilbegit 50 mg daily, along with supplements Triovit and folic acid, each taken once daily for three months. The treatment period includes hospitalization for observation during the first week after injection and outpatient follow-up visits. The trial consists of three periods a screening phase up to 15 days before treatment, a study drug administration and inpatient follow-up from day 1 to day 7, and a follow-up period lasting through day 90. Participants will undergo semen analyses at 90 days to measure sperm quality, which is the primary outcome of the study. Additional measures include tracking changes in hormone levels such as inhibin B. The total time involved in the study will not exceed 119 days, including screening and follow-up. After study completion, participants will be monitored for an additional year to observe any delayed side effects or adverse events. The study is randomized and participants receive either the investigational drug or the active comparator treatment under single-blind conditions.

Study of Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Medicinal Product MediReg®