Clinical Trials Logo

Clinical Trial Summary

The investigators are testing the hypothesis that two ounces of whole-shelled walnuts/day added to the diet of men seeking care for infertility will beneficially affect sperm parameters and fertility. The investigators will compare the walnut intervention to the commonly suggested recommendation of adding an OTC multivitamin supplement to the diet.


Clinical Trial Description

Purpose: The investigators are testing the hypothesis that two ounces of whole-shelled walnuts/day added to the diet of men with oligo- astheno- or teratospermia will beneficially affect sperm parameters. The investigators found in a previous study (Robbins et al. 2012, Biology of Reproduction 87(4):101, 1-8.) that walnuts added to a Western diet improved sperm parameters in healthy, young men of unknown fertility and the most improvement occurred in participants with poor sperm parameters at baseline. The investigators now test the walnut dietary intervention in a fertility clinic population known to have poor sperm parameters. The investigators will compare the walnut intervention to the usual care suggestion of adding an OTC multivitamin supplement to the diet. Neither walnuts nor the OTC multivitamin have been tested for efficacy in this fertility clinic population previously. Methods: A randomized, parallel two-group, dietary intervention trial with single-blind masking of outcome assessors will be conducted with up to 140 men who present for fertility work-up with semen parameters below the 25th centile for count, and 10th centile for motility and/or morphology according to the WHO 5th Edition, Laboratory Manual for the Processing and Examining of Human Semen, 2010. Repeated measures at baseline and 12 weeks include: semen analyses (primary outcome), blood fatty acid/ nutrient profiles (secondary outcomes); IPAQ physical activity questionnaire and IIEF index of erectile function (potential modifiers or confounders). Dietary intake will be assessed throughout using 24-hour ASA dietary recall x 5 and fertility assessed by questionnaire at one year post enrollment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01954498
Study type Interventional
Source University of California, Los Angeles
Contact
Status Completed
Phase N/A
Start date May 2014
Completion date March 2020

See also
  Status Clinical Trial Phase
Withdrawn NCT02759705 - Bladder Exstrophy (FIVES FertIlity Vesical Exstrophy Sexuality)
Not yet recruiting NCT02534857 - A Study Comparing a Shorter Exposure of Oocyte to Spermatozoa Versus a Standard Incubation on the Live Birth Rate of In-vitro Fertilization Treatment N/A
Enrolling by invitation NCT01803893 - Prognostic Value of PIF Detection in Embryo Culture Media Correlation With Pregnancy Outcome N/A
Completed NCT01888744 - Preimplantation Genetic Diagnosis (PGD) With Gonadotropin-releasing Hormone (GnRH) Agonist Versus Antagonist Phase 4
Terminated NCT01173276 - Intrauterine Insemination In HIV-Discordant Couples N/A
Not yet recruiting NCT03680937 - Methods for Fertility Preservation: Impact of Vitrification on in Vitro Matured Oocytes
Completed NCT03455062 - Fertility Study of Women Who Received Organ Transplantation N/A
Completed NCT02736214 - Reproductive Life Plan-based Counseling With Men N/A
Terminated NCT01614704 - Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility
Completed NCT01895192 - Sperm Morphology by High Magnification in Fertility Men N/A
Terminated NCT01232972 - Oocyte Cryopreservation N/A
Terminated NCT01268592 - Fertility Preservation in Female Cancer Patients N/A
Completed NCT01012596 - Creighton Model Effectiveness, Intentions and Behaviors Assessment (CEIBA)
Completed NCT00390754 - Usefulness of Home Pregnancy Testing N/A
Completed NCT00231504 - Study of Follicle Stimulating Hormone (FSH) Receptor in Women With Low Antral Follicle Count Phase 1
Completed NCT03345264 - The Find Your PATHS (Pragmatic Assessment of a Tool to Help Survivors) to Sexual Health and Parenthood Study N/A
Recruiting NCT05414812 - Intervening on Women's Health for Rural Young Breast Cancer Survivors N/A
Active, not recruiting NCT02661932 - Fertility Preservation in Breast Cancer Patients Phase 4
Recruiting NCT06172504 - Ejaculation Frequency and Semen Parameters
Recruiting NCT02878434 - Fertility Preservation in Young Women With Cancer