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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)

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07800052
Acronym
STEMRN
Enrollment
60
Registered
2026-09-02
Start date
2024-10-15
Completion date
2026-03-20
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male Infertility, Oligoasthenospermia

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTStemregen

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

Sponsors

Kocaeli University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
No

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 \-

Design outcomes

Primary

MeasureTime frameDescription
Change in Sperm CountBaseline and 3 monthsChange in Sperm Count from baseline to after 3 months of Stenregen supplementation,assessed by semen analysis

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORMustafa Melih Çulha, MD

Kocaeli UNİVERSİTY HOSPİTAL

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026