CClinicalTrials.gg
CompletedNCT07800052STEMRNUpdated Sep 2, 2026

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)

An interventional study of Stemregen in Male Infertility and Oligoasthenospermia, sponsored by Kocaeli University. Completed at 1 site in Turkey (Türkiye). Open to male participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Kocaeli University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
20 Years to 50 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Male Infertility
  • Oligoasthenospermia

Browse trials for

03

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

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

-

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Stemregen Treatment Group

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

    Dietary Supplement: Stemregen

  • No intervention
    Control Group

    participants received no additional treatment during the study period

Interventions

  • Dietary supplementStemregen

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

05

What researchers measure

Primary outcomes

  1. Change in Sperm Count

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

    Time frame: Baseline and 3 months

06

Study locations

1 site
  • Kocaeli Unversity Hospital
    Köseköy, Kocaeli 41001, Turkey (Türkiye)
07

Registry details

Key details

Study ID
NCT07800052
Lead sponsor
Kocaeli University
Responsible party
Omar Mohammed Ali Abdulghafoor Alzamo (Research Assistant, Kocaeli University) — Principal investigator
First posted
Sep 2, 2026
Start date
Oct 15, 2024
Primary completion
Mar 20, 2026
Completion
Mar 20, 2026
Last update
Sep 2, 2026

Study contacts

Mustafa Melih Çulha, MD
principal investigator · Kocaeli UNİVERSİTY HOSPİTAL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion