Trial reportReproductive biology and endocrinology : RB&E2014
The importance of the one carbon cycle nutritional support in human male fertility: a preliminary clinical report.
Trial report in Reproductive biology and endocrinology : RB&E, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03337360 (The Impact of a Nutritional Supplement), which is not on this map. Cited by 24 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Impact of a Nutritional Supplement (Impryl®) on Male Fertility
Who cites it
24 citing papers in PubMed, 47 citations in OpenAlex.
- Antioxidant Treatment and the Chance to Conceive in Men Seeking Fertility Care: The SUMMER Randomized Clinical Trial.JAMA network open · 2025Trial
- Effect of a short-term vitamin E supplementation on oxidative stress in infertile PCOS women under ovulation induction: a retrospective cohort study.BMC women's health · 2020Trial
- Comparison of the Effect of Multiple Dietary Supplements on the Quality of Sperm Parameters in Elite and Amateur Soccer Players.Journal of nutrition and metabolism · 2025Article
- The Role of One-Carbon Metabolism and Methyl Donors in Medically Assisted Reproduction: A Narrative Review of the Literature.International journal of molecular sciences · 2024Review
- Antioxidants in Male Infertility-If We Want to Get This Right We Need to Take the Bull by the Horns: A Pilot Study.Antioxidants (Basel, Switzerland) · 2023Article
- Dietary macrominerals: Updated review of their role and orchestration in human nutrition throughout the life cycle with sex differences.Current research in food science · 2023Review
- The lack of evidence behind over-the-counter antioxidant supplements for male fertility patients: a scoping review.Human reproduction open · 2023Article
- The Relationship between Plant-Based Diet Index and Semen Parameters of Men with Infertility: A Cross-Sectional Study.International journal of fertility & sterility · 2022Article
- Sperm as a Carrier of Genome Instability in Relation to Paternal Lifestyle and Nutritional Conditions.Nutrients · 2022Article
- Diet and human reproductive system: Insight of omics approaches.Food science & nutrition · 2022Review
- The relationship between major dietary patterns and fertility status in iranian men: a case-control study.Scientific reports · 2021Article
- Sperm DNA fragmentation testing: Summary evidence and clinical practice recommendations.Andrologia · 2021Review
- Antioxidant-Based Therapies in Male Infertility: Do We Have Sufficient Evidence Supporting Their Effectiveness?Antioxidants (Basel, Switzerland) · 2021Review
- Article
- Micronutrients in Support to The Carbon Cycle Activate Antioxidant Defences and Reduce Sperm DNA Damage in Infertile Men Attending Assisted Reproductive Technology Programs: Clinical Trial Study.International journal of fertility & sterility · 2020Article
- Relationship between Sperm Parameters with Sperm Function Tests in Infertile Men with at Least One Failed Cycle after Intracytoplasmic Sperm Injection Cycle.International journal of fertility & sterility · 2020Article
- Nutrition and Female Fertility: An Interdependent Correlation.Frontiers in endocrinology · 2019Review
- MTHFR isoform carriers. 5-MTHF (5-methyl tetrahydrofolate) vs folic acid: a key to pregnancy outcome: a case series.Journal of assisted reproduction and genetics · 2018Article
- A pilot study on sperm DNA damage in β-thalassemia major: is there a role for antioxidants?Acta bio-medica : Atenei Parmensis · 2018Article
- CondensylEFSA journal. European Food Safety Authority · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSperm chromatin structure is often impaired; mainly due to oxidative damage. Antioxidant treatments do not consistently produce fertility improvements and, when given at high doses, they might block essential oxidative processes such as chromatin compaction. This study was intended to assess the effect on male sub-fertility of a pure one carbon cycle nutritional support without strong antioxidants.
methodsMale partners of couples resistant to at least 2 assisted reproductive technology (ART) attempts, with no evidence of organic causes of infertility and with either DNA fragmentation index (DFI) measured by Terminal deoxynucleotidyl transferase dUTP Nick End Labeling (TUNEL) or nuclear decondensation index (SDI) measured by aniline blue staining exceeding 20%, were invited to take part in a trial of a nutritional support in preparation for a further ART attempt. The treatment consisted of a combination of B vitamins, zinc, a proprietary opuntia fig extract and small amounts of N-acetyl-cysteine and Vitamin E (Condensyl™), all effectors of the one carbon cycle.
results84 patients were enrolled, they took 1 or 2 Condensyl™ tablets per day for 2 to 12 months. Positive response rates were 64.3% for SDI, 71.4% for DFI and 47.6% for both SDI and DFI. Eighteen couples (21%) experienced a spontaneous pregnancy before the planned ART cycle, all ended with a live birth. The remaining 66 couples underwent a new ART attempt (4 IUI; 18 IVF; 44 ICSI) resulting in 22 further clinical pregnancies and 15 live births. The clinical pregnancy rate (CPR) and the live birth rate (LBR) were 47.6% and 39.3% respectively. The full responders, i.e. the 40 patients achieving an improvement of both SDI and DFI, reported a CPR of 70% and a LBR of 57.5% (p<0.001).
conclusionsNutritional support of the one carbon cycle without strong antioxidants improves both the SDI and the DFI in ART resistant male partners and results in high pregnancy rates suggesting a positive effect on their fertility potential.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.