A Phase 1 interventional study of Omega 3 fatty acid and Placebo oral capsule in Male Infertility Due to Hypospermatogenesis, sponsored by Jinling Hospital, China. Status unknown at 1 site in China. Open to male participants aged 21 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-09-16.
Sponsored by Jinling Hospital, China · Phase 1, Interventional, and Treatment
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Among 10 studies in Infertility, Male with a site in China — 3 open to participants now, 3 under way, none of them phase 3. Infertility, Male · China.
Among the 10 studies in Infertility, Male with a site in China, this one is one of 2 that started in 2017, is the only one in phase 1, and was the 4th registered.
282 studies on the registry are indexed under Infertility, Male; 65 are open to participants now.
Browse Infertility, Male studies →3 of the 10 studies in Infertility, Male with a site in China are open now. Recruiting first, the newest first:
ShangHai Ji Ai Genetics & IVF Institute · Sites in China
Ages 20–37
Zhujiang Hospital · Sites in China
Ages 18–45 · Men only · Healthy volunteers
The Third Affiliated Hospital of Guangzhou Medical University · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 40 Infertility, Male studies recruiting now, 16 (40%) set no upper age limit and 24 (60%) stop at 75 or younger; 7 take children under 18; 14 take healthy volunteers.
This study: 21 Years to 45 Years · male · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 2 started in 2017.
This study's planned enrollment of 30 is below the median of 80 across 187 interventional studies indexed under Infertility, Male.
Median enrollment 134 across the 6 interventional studies, 753 across the 4 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
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None of the 10 has an industry lead sponsor. The 9 most frequent:
Jinling Hospital, China is the lead sponsor of 131 studies on the registry; 35 are open to participants now.
Jinling Hospital, China has 2 studies filed under Infertility, Male — fewer than ten, so there is no comparison to draw.
2 of the studies in Infertility, Male with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06561451ShangHai Ji Ai Genetics & IVF InstituteLive Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia | 2026-12-30 |
| NCT07691827The Third Affiliated Hospital of Guangzhou Medical UniversityMaternal Inheritance of a Pathogenic MT-ND1 Mutation Causes Mitochondrial Dysfunction and Spermatogenic Failure in Men | 2027-04-01 |
Add all 2 to your calendar (.ics) → With an account.
Among the 10 studies in Infertility, Male with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Investigators have previously found that sperm quality was not related to obesity indicators, such as body mass index (bmi), waist circumference, waist-hip ratio, girth ratio and serum lipid, but seminal plasma lipids could notably affect the sperm concentration, sperm progressive ratio(PR), sperm DNA fragmentation index (DFI). These results indicates that abnormal lipid metabolism in the male reproductive system may affect male fertility.
It seems that the sperm fatty acid spectrum is associated with n-3 polyunsaturated fatty acids (PUFA) in dietary. Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) are the most common n-3 PUFA. Only plasma DHA/EPA may reflect the quantity of DHA/EPA in adults. Most research indicate that n-3 PUFA is the main polyunsaturated fatty acid in human sperm.
It is well known that diets have great influence on the gut microbiota composition. Many researches have delineated the cause and effect relationship between disturbed gut microbes and diseases, such as irritable bowel syndrome, obesity, diabetes. The disturbed gut microbiota ecosystem may also lead to the intestinal mucosal permeability increasing, which may result in endotoxemia and a series of metabolic syndrome. N-3 polyunsaturated fatty acids may play an important role in regulating metabolism and physiological functions in the body. A clinical research found that both total n-3 PUFA and DHA serum levels were significantly correlated with microbiome alpha diversity. Therefore, investigators may try to figure out the influence of n-3 PUFA supplement on gut microbiota composition and whether the gut microbiota have influence on sperm parameters. So investigators apply for your permission to collected the fecal samples from the participants, which will be a meaningful work.
In the previous work, investigators found high fat diet induced gut microbiota dysbiosis can lead to low sperm motility and sperm count, and also recognised some microbes which may lead to the low sperm motility and sperm count. It is obvious that gut microbiota can influence the sperm quality. And the supplement of n-3 PUFA is significantly correlated with microbiome alpha diversity. So investigators want to collected the fecal samples from the participants, to ascertain whether the supplementation of n-3 PUFA can promote sperm parameters by improve gut microbiota ecosystem.
The potential microbes planing to cultivate: Prevotella spp, bacteroides spp.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1g per capsule(EPA400mg，DHA320mg)
Drug: Omega 3 fatty acid
The placebo capsule has same appearance and packing with the Omega-3 fatty acid capsule
Drug: Placebo oral capsule
Omega 3 fatty acid,mainly composed of EPA and DHA.
Also known as: Placebo Capsule
mainly composed of corn oil
sperm concentration
sperm concentration
Time frame: 40 days
progressive ratio
progressive sperm concentration/total sperm concentration
Time frame: 40 days
DNA fragmentation index
DNA fragmentation index
Time frame: 40 days
gut microbiota composition
variation of gut microbiota composition collecting from patients' fecal sample
Time frame: 40 days
Ran from Nov 2017 to primary completion in Mar 2019, 16 months.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Omega-3 fatty acid