Infertility, Male

13

Review clinical trials related to Infertility, Male. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Measuring Free Radicals in Human Sperm Cells Related to Microbiota and Lifestyle Factors

The cause of infertility can be due to a female factor or a male factor. In case of a male factor, it is often due to poor semen quality. However, the cause of poor quality is often unknown. In previous research, infertility problems in men were related to chemical processes in metabolism causing the formation of free radicals. Free radicals are physiological by-products of our body mechanisms. Free radicals are very reactive and can therefore react with a lot of molecules of cells within our body and cause damage. A balance between free radicals, which are also needed for physiological processes in the body, and antioxidants, which defuses the reactive free radicals, is most desirable. However, as stated in literature, there are a lot of factors that can influence extra free radical production, which causes overloading of the system, resulting in damage on cellular level. Free radicals in semen plasma and on the sperm cell could play a role in male infertility. Nonetheless, free radicals are not used as diagnostic markers due to the lack of detection systems, as free radicals are very short-lived. This study aims to introduce a new technique, called diamond magnetometry, to measure free radicals directly on the sperm cell and in serum. Diamond magnetometry involves very small diamond particles as magnetic sensors that engage a reaction with the free radicals on the sperm cell, causing signals that can be measured. To compare local free radical production with systemic free radical production, other diagnostic biomarkers are also measured in serum. It is hypothesized that the composition of seminal microbiome could influence the free radical concentration. Therefore, this study also aims to explore the microbiota composition and see if this has an influence in semen quality and free radical production. At last, this study also want to correlate standard semen parameters (defined by the World Health Organisation), lifestyle factors and food intake, to detect a role for lifestyle in the production of free radicals.

Participants needed: 80
Trial details
Age: 18-55Biological sex: MaleType: ObservationalSponsor: University Medical Center GroningenUpdated: May 8, 2026Locations: 1
Eligibility criteria

Males of couples visiting the CRM at the UMCG between 18-55 years old. [+1]

Males who receive(d) chemo- and/or radiotherapy, use(d) testosterone suppletion... [+4]

Status: Not yet recruiting

A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia

This clinical interventional study aims to assess whether treatment with with leflutrozole can improve sperm production in infertile men with non-obstructive azoospermia selected by serum anti-mullerian hormone (AMH) or Inhibin B as a positive predictive biomarker.

Participants needed: 15
Trial details
Phase: Phase 1, Phase 2Age: 18-55Biological sex: MaleType: InterventionalSponsor: Martin Blomberg JensenUpdated: May 6, 2026Locations: 1
Eligibility criteria

Signed informed consent by participant [+6]

Klinefelter or other major genetic conditions including large deletions on sex c... [+17]

Status: Recruiting

Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting

Spermatogonial stem cell transplantation through ultrasound guided rete testis injection and testicular tissue grafting will be performed for participants who have frozen testicular tissue prior to gonadotoxic therapy. The purpose of this study is to test the safety and feasibility of these transplant technologies and restore fertility for these participants.

Participants needed: 10
Trial details
Biological sex: MaleType: InterventionalSponsor: University of PittsburghUpdated: Apr 22, 2026Locations: 1
Eligibility criteria

Male participant at least in Tanner stage 3 [+3]

Participants considered to be high risk for surgical complications [+2]

Status: Recruiting

Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)

This is a study of infertility which often occurs in men with spinal cord injury. Most men with spinal cord injury have a normal sperm count but abnormally low sperm motility - which means that the sperm does not swim well. This study will determine if a medicine given by mouth will improve sperm motility in men with spinal cord injuries. The medicine is called probenecid.

Participants needed: 90
Trial details
Phase: Phase 3Age: 18+Biological sex: MaleType: InterventionalSponsor: University of MiamiUpdated: Mar 2, 2026Locations: 1
Eligibility criteria

Subject has a traumatic spinal cord injury. [+1]

Subject has been injured less than 1 year. [+12]

Status: Recruiting

Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples

The purpose of this research study is to evaluate if special types of cells called round spermatids can be gathered from men with non-obstructive azoospermia and used (in absence of elongated spermatids and spermatozoa) to reliably and effectively create pregnancy with a procedure called Round Spermatid Injection (ROSI). This process is similar to In Vitro Fertilization, or 'IVF'. In addition, this study wants to test the safety of ROSI and see what effects (good and bad) it has on embryo created from this method.

Participants needed: 50
Trial details
Age: 18+Biological sex: MaleType: InterventionalSponsor: Wake Forest University Health SciencesUpdated: Sep 16, 2025Locations: 1
Eligibility criteria

Males with no elongated spermatids or spermatozoa present but with round spermat... [+3]

Males with obstructive azoospermia [+1]

Status: Not yet recruiting

Cell Free Preimplantation Genetic Testing

This study aims to develop preimplantation genetic testing methods from embryo culture media (cell free). Genetic testing of culture media will be compared to conventional methods based on embryo biopsies.

Participants needed: 200
Trial details
Biological sex: AllType: ObservationalSponsor: Genomic Prediction Inc.Updated: Aug 26, 2025Locations: 1
Eligibility criteria

Patients undergoing IVF electing to utilize LifeView testing (PGT) will be offer...

None

Status: Recruiting

The Effect of Supplementation With Fish Oil (EPAX EVOLVE 05) on Sperm Quality

The study will enrol men that have a poor sperm quality. They will take either a placebo or fish oil capsule (2 per day) for 3 months. At the beginning and end of the study the participant will be asked for a sperm sample for measuring quality parameters.

Participants needed: 80
Trial details
Age: 18-55Biological sex: MaleType: InterventionalSponsor: Epax Norway ASUpdated: May 1, 2025Locations: 1
Eligibility criteria

Men aged 18-55 [+3]

Known allergy to fish products [+6]

Status: Recruiting

Prospective Study on Power Prenatal Vitamins for Males on YO Score At-home Sperm Test Results

Male factor infertility is a leading cause of primary and secondary infertility. Poor sperm quality is defined as having an abnormal semen analysis. There are now options to assess sperm quality with at-home sperm analysis kits, including an FDA approved Yo Sperm kit (https://yospermtest.com/) which analyzes the motile sperm concentration \[concentration (millions / ml) x motility (Percentage motile)\] and sperm quality (YO Score) which compares your results to laboratory standards and to other men who have fathered children. The effects of supplements (vitamins, minerals, and anti-oxidants) on improving sperm quality are still debated. Taking additional supplements to improve sperm quality represent a modifiable risk-factor that would be an easy intervention for patients struggling with male factor infertility. The life cycle of sperm production is estimated at 3 months, so any intervention would require a 3 month course to see its full effect. The investigators hypothesize that a 90 day course of the "Power Prenatal for Sperm", a male fertility supplement by Bird\&Be (https://birdandbe.com/the-power-prenatal-for-sperm) will improve sperm quality (YO Score) after taking the supplements.

Participants needed: 174
Trial details
Age: 18-50Biological sex: MaleType: InterventionalSponsor: The Bird and Be Co IncUpdated: Apr 8, 2025Locations: 1
Eligibility criteria

Male patients with at-home YO Sperm score between 20-40, corresponding to a MSC... [+2]

Active smokers [+2]

Status: Recruiting

Power Prenatal Supplements for Sperm Quality

Male factor infertility is a leading cause of primary and secondary infertility. Poor sperm quality is defined as having an abnormal semen analysis \[WHO 2020 - https://www.who.int/publications/i/item/9789240030787\]. The effects of supplements (vitamins, minerals, and anti-oxidants) on improving sperm quality are still debated (https://pubmed.ncbi.nlm.nih.gov/30462179). Taking additional supplements to improve sperm quality represent a modifiable risk-factor that would be an easy intervention for patients struggling with male factor infertility. The life cycle of sperm production is estimated at 3 months, so any intervention would require a 3 month course to see its full effect. The investigators hypothesize that a 90 day course of the "Power Prenatal for Sperm", a male fertility supplement by Bird\&Be (https://birdandbe.com/the-power-prenatal-for-sperm) will improve sperm quality based on semen analysis results prior to, and after taking the supplements.

Participants needed: 50
Trial details
Age: 18-45Biological sex: MaleType: InterventionalSponsor: The Bird and Be Co IncUpdated: Apr 8, 2025Locations: 1
Eligibility criteria

Male [+6]

No diagnosed varicocele [+3]

Status: Recruiting

Spermatogonial Differentiation Via Testicular Organoid

Purpose: This clinical trial aims to explore the potential for human sperm production in vitro by sustaining a laboratory-cultured adult testicular environment. It also seeks to identify genetic factors contributing to human sterility and failed spermatogenesis. The study's primary objectives include: 1. Identifying genomic markers associated with sterility and failed spermatogenesis. 2. Developing an ex vivo (outside the body) testis "organ-on-a-chip" ("iTestis") to support stem cell cultivation. 3. Determining whether human spermatogenesis can be re-created in vitro using stem cells nurtured in the iTestis model. Study Description: Researchers will analyze the genomic profiles of fertile and sterile male participants to map genetic abnormalities associated with sterility. Using testicular and skin tissue samples from participants, spermatogonial stem cells and pluripotent stem cells will be isolated and utilized to construct the ex vivo iTestis. This system will integrate genomic insights and prior research to foster human spermatogenesis outside the body. Participant Involvement: Participants will provide the following samples: * Blood sample for serum analysis. * A skin tissue biopsy. * Testicular tissue, obtained through fine needle aspiration (FNA) or testicular sperm extraction (TESE), as part of a routine procedure. All procedures will be conducted by the principal investigator and qualified research staff, ensuring participant safety and adherence to ethical guidelines.

Participants needed: 100
Trial details
Phase: Phase 1, Phase 2Age: 18-60Biological sex: MaleType: InterventionalSponsor: CellARTs Inc.Updated: Feb 24, 2025Locations: 1
Eligibility criteria

Male sex of reproductive age (between 18 - 60 years old). [+6]

Status: Recruiting

Aftificial Inteligence in Assisted Reproductive Techniques to Assess Oocyte Quality and Embryo Ploidy

The assisted reproduction success rate is affected by several factors including the age of the women, oocyte quality and maturation state, as well as sperm quality. Imaging of the meiotic spindle may be crucial for determining the oocyte maturation. Artificial intelligence (AI) will be applied to establish the complex oocyte quality, embryo ploidy and pregnancy success probability from the sequence of data, starting with the recording of the meiotic spindle in polarized light, through paternal factors up to the time lapse recording of early embryo development. This strategy should reduce the cost of fertility treatment thanks to increased efficiency in choosing the most promising candidates and reducing the need for costly laboratory analyses.

Participants needed: 1,000
Trial details
Age: 18-49Biological sex: AllType: ObservationalSponsor: Charles University, Czech RepublicUpdated: Jan 22, 2025Locations: 4
Eligibility criteria

Intracytoplasmatic Sperm Injection [+3]

Gynecological diseases [+1]

Status: Recruiting

The Association of Gut Microbiota and Spermatogenic Dysfunction

This is a multicenter, case-control study that aims to investigate the relationship between microbiota and sperm quality via stool, blood, and urine microbiome, metabolomics, and collected clinical metadata. The results of the spermatogenic dysfunction, including aspermia, oligozoospermia, asthenozoospermia, and teratozoospermia, will be compared to normal basic semen analysis utilizing the World Health Organization (WHO) semen analysis procedure 5th edition.

Participants needed: 306
Trial details
Age: 18-45Biological sex: MaleType: ObservationalSponsor: Zhujiang HospitalUpdated: Jul 24, 2024Locations: 3
Eligibility criteria

Aged 18 to 45 years, males [+3]

Age < 18 or > 45 years [+5]

Status: Recruiting

Study of the ZyMōt Sperm Selection Method and Its Effect on Embryo Ploidy.

It has been described that 11% of men with semen values within the normal range established by the World Health Organization (WHO) have sperm DNA fragmentation. This has been associated with a lower fertilization rate, lower embryo development and, therefore, lower reproductive success. Focusing on the study of the integrity of the male genome can provide us information to diagnose infertility in the couple. The use of conventional sperm selection methods such as swim-up or density gradients has been a great advance in the improvement of male fertility. However, these methods use centrifugation in their protocol, a procedure that has been associated with sperm DNA damage. The ZyMōt is a chip based on microfluidic properties that allows the recovery of spermatozoa with lower DNA fragmentation rate without centrifugation of the semen sample. This new sperm selection method maintains all the advantages of conventional techniques, but decreasing DNA fragmentation associates to sperm recoveries techniques eventually improving reproductive rates. This quality would be beneficial for patients with unexplained infertility, recurrent pregnancy loss or clinical varicocele, factors that have been associated with a higher index of DNA fragmentation. However up to date there is evidence-based data supporting such improvement. The main objective of the present project is to evaluate the ZyMōt as a new non-invasive sperm selection device and to see its impact on the euploidy rate, comparing it with a sperm selection technique that is routinely used in the clinic: swim-up. At the same time, the effect that this new chip may have on sperm and other reproductive variables will be analyzed clinically, and molecularly with immunohistochemical and transcriptomic analyses in order to observe the impact of SDF(sperm DNA fragmentation) at the molecular and genomic level in oocytes with low reparative potential oocytes.

Participants needed: 80
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Instituto Valenciano de Infertilidad, IVI VALENCIAUpdated: Apr 29, 2024Locations: 2
Eligibility criteria

Couples undergoing an ICSI cycle with PGT-A (Preimplantational Genetic Test for... [+4]

Males with severe asthenozoospermia (<10% progressively motile spermatozoa), glo... [+4]