Male InfertilitySTEMRNNCT07800052
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)
A study testing Stemregen in people with Male Infertility and Oligoasthenospermia, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Male Infertility, Oligoasthenospermia
- What is being tested?
- Stemregen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 20 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- No healthy volunteers
- Adult
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
-
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli Unversity Hospital
Köseköy, Kocaeli, 41001
About this study
Official 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
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.
- Conditions
- Male Infertility, Oligoasthenospermia
- Being tested
- Stemregen
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StemregenDietary supplement
participants received standard-dose Stemregen® dietary supplementatıon for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Stemregen Treatment Group | Experimental | participants received standard-dose Stemregen®dietary supplementatıon for 3 months Receives: Dietary Supplement: Stemregen |
| Control Group | No intervention | participants received no additional treatment during the study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sperm Count
Change in Sperm Count from baseline to after 3 months of Stenregen supplementation,assessed by semen analysis
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start15 Oct 2024
- Primary completion20 Mar 2026
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mohammed Ali Abdulghafoor Alzamo, Kocaeli University
- Investigators
- Mustafa Melih Çulha, MD, Principal investigator, Kocaeli UNİVERSİTY HOSPİTAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800052
- Sponsor's protocol ID
- ICS1
- Acronym
- STEMRN
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07800052
- Acronym / sponsor ID
- STEMRN / ICS1
- Conditions
- Male Infertility, Oligoasthenospermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stemregen Treatment Group | Experimental | Dietary Supplement: Stemregenparticipants received standard-dose Stemregen®dietary supplementatıon for 3 months |
| Control Group | No intervention | –participants received no additional treatment during the study period |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stemregenparticipants received standard-dose Stemregen® dietary supplementatıon for 3 months | Dietary supplement | Stemregen Treatment Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa Melih Çulha, MD principal investigator
Kocaeli UNİVERSİTY HOSPİTAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stemregen in people with Male Infertility and Oligoasthenospermia, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sperm Count (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.