The Effects of Diet on Small Non-coding RNA i Sperm Cells and the Possible Effects on Reproductive Success: Diet Intervention Effects on Sperm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diet intervention NMR.
- Who it may be relevant to
- Registry conditions: Changes in sncRNA in Sperm, Male Fertility, RNA Profile. Basic parameters: 23 years — 56 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Molecular Mechanisms for Male Fertility: Can Diet Change Sperm sncRNA and the Reproductive Potential?
Overview
In this study, patients with infertility treated with IVF at the Center of Reproductive Medicine in Linköping, Sweden, will receive recipes and food according to Nordic dietary guidelines. The purpose is to investigate whether a short diet intervention is sufficient to improve sperm quality and shift the small non-coding RNA profile. In our previous study sperm showed rapid response to diet.
Detailed description
This study is a randomized controlled trial recruiting males seeking IVF treatment with their female partner at the Center for Reproductive Medicine in Linkoping, Sweden. Men will be randomized to a control group or diet intervention group.
The intervention group will receive groceries with planned recipes during the hormonal treatment period for the woman (11-14 days) before IVF. The meal plan will be according to the Nordic dietary guidelines and individualized to match total energy expenditure.
The male partner must accept to participate in the diet intervention in order to be included and the female partner can choose to participate in the diet intervention but it is optional. Sperm samples will be collected before the start of hormonal treatment and on ovum pick-up day. Weight will be measured before and after the intervention. Sperm samples will be processed as standard practice at the fertility clinic. Sperm samples will be used for molecular analysis, such as small RNA sequencing.
Interventions
- Dietary supplement Diet intervention NMR
Participants will receive groceries to their homes with planned recipes. The recipes are planned by using the Nordic nutrition councils recommendations.
Primary outcome measures
- Sperm RNA profile changes [Time frame: At day at ovum pick-up]
- Sperm total count [Time frame: At day of ovum pick-up]
- Sperm concentration [Time frame: At day of ovum pick-up]
- Sperm sample analysis [Time frame: At day of ovum pick-up]
Secondary outcome measures (5)
- Fertilization rate [Time frame: Day one after ovum pick-up]
- High quality embryo rate [Time frame: Day 6 after ovum pick-up]
- Embryos frozen [Time frame: Day 5 and/or 6 after ovum pick-up]
- Clinical pregnancy rate [Time frame: Assessed 5-7 weeks after ovum pick-up]
- Pregnancy rate [Time frame: Assessed three weeks after ovum pick-up]
Eligibility criteria
Inclusion criteria
- Male (biological) partner in infertile couple, scheduled for first IVF treatment
- Mature sperm cells in semen
- Able to speak and read Swedish
- Omnivore
- Will refrain from nicotine and alcohol during intervention
- Sperm sampled provided no more than 3 weeks before intervention start
Exclusion criteria
- Former or present malignant disease
- Former radiotherapy in pelvic area
- Former chemotherapy
- Known genetic/chromosomal disorder
- Food allergy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Sweden · 1 center
- University Hospital — Linköping
Identifiers
NCT: NCT06831292 · RÖ-961659 substudy 3