Investigation of the Effects of Stem Cell Supportive Treatment on Semen Parameters and Assisted Reproductive Techniques (ICSI) in Infertile Male Patients With Oligoasthenospermia(Decrease Sperm Number and Quality)

This study evaluated whether Stemregen® dietary supplementation could improve sperm quality and assisted reproductive treatment outcomes in men with severe oligoasthenozoospermia who had previously experienced at least one failed intracytoplasmic sperm injection (ICSI) attempt. A total of 60 men were included and divided into a treatment group and a control group. Participants in the treatment group received Stemregen® dietary supplementation for 3 months, while the control group received no additional treatment. Semen parameters, sperm DNA fragmentation, fertilization, embryo transfer, and pregnancy outcomes were evaluated and compared between the groups.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Male Infertility Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Oligoasthenospermia Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli Unversity Hospital

Köseköy, Kocaeli, 41001, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

men aged 20-50 years with severe oligoasthenozoospermia, defined for the purposes of the study as a sperm concentration <5 × 10⁶/mL with markedly reduced progressive motility, and at least one previous unsuccessful intracytoplasmic sperm injection (ICSI) cycle. -

Exclusion criteria

clinically significant varicocele requiring surgical correction, obstructive azoospermia, hypogonadotropic hypogonadism, primary testicular failure, chromosomal abnormalities or known genetic causes of infertility, active genitourinary infection, uncontrolled diabetes mellitus, severe systemic disease, malignancy, previous chemotherapy or pelvic radiotherapy, and hormonal or antioxidant treatment within the preceding three months. Female partners underwent routine infertility evaluation, and couples with severe female infertility factors, including diminished ovarian reserve, advanced endometriosis, major uterine abnormalities, or severe ovulatory dysfunction

Treatment and study plan

Stemregen

Dietary Supplement

participants received standard-dose Stemregen® dietary supplementatıon for 3 months

Primary outcomes

Change in Sperm Count

Time frame: Baseline and 3 months

Change in Sperm Count from baseline to after 3 months of Stenregen supplementation,assessed by semen analysis

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

Association of Three-Month Stemregen® Supplementation With Sperm Functional Parameters, DNA Fragmentation, and ICSI Outcomes in Men With Severe Oligoasthenozoospermia: A Prospective Non-Randomized Controlled Study

Acronym: STEMRN

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Sep 2, 2026
Registry last updated: Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed