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)
STEMRN
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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2026
CompletedFirst Submitted
Initial submission to the registry
August 28, 2026
CompletedFirst Posted
Study publicly available on registry
September 2, 2026
CompletedSeptember 2, 2026
August 1, 2026
1.4 years
August 28, 2026
August 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Sperm Count
Change in Sperm Count from baseline to after 3 months of Stenregen supplementation,assessed by semen analysis
Baseline and 3 months
Study Arms (2)
Stemregen Treatment Group
EXPERIMENTALparticipants received standard-dose Stemregen®dietary supplementatıon for 3 months
Control Group
NO INTERVENTIONparticipants received no additional treatment during the study period
Interventions
participants received standard-dose Stemregen® dietary supplementatıon for 3 months
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kocaeli Unversity Hospital
Köseköy, Kocaeli, 41001, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mustafa Melih Çulha, MD
Kocaeli UNİVERSİTY HOSPİTAL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
August 28, 2026
First Posted
September 2, 2026
Study Start
October 15, 2024
Primary Completion
March 20, 2026
Study Completion
March 20, 2026
Last Updated
September 2, 2026
Record last verified: 2026-08