Clinical trial NCT06831292: The Effects of Diet on Small Non-coding RNA I Sperm Cells and the Possible Effects on Reproductive Success: Diet Intervention Effects on Sperm
Official title: Molecular Mechanisms for Male Fertility: Can Diet Change Sperm SncRNA and the Reproductive Potential?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Changes in SncRNA in Sperm
Male Fertility
RNA Profile
Keywords: male fertility
small non-coding RNA
diet
infertility
reproduction
diet intervention
Lead sponsor: Ostergotland County Council, Sweden
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 100
Sex: MALE
Minimum age (years): 23
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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

Primary outcomes:
measure: Sperm RNA profile changes
timeFrame: At day at ovum pick-up
measure: Sperm total count
timeFrame: At day of ovum pick-up
measure: Sperm concentration
timeFrame: At day of ovum pick-up
measure: Sperm sample analysis
timeFrame: At day of ovum pick-up
Secondary outcomes:
measure: Fertilization rate
timeFrame: Day one after ovum pick-up
measure: High quality embryo rate
timeFrame: Day 6 after ovum pick-up
measure: Embryos frozen
timeFrame: Day 5 and/or 6 after ovum pick-up
measure: Clinical pregnancy rate
timeFrame: Assessed 5-7 weeks after ovum pick-up
measure: Pregnancy rate
timeFrame: Assessed three weeks after ovum pick-up
Other outcomes:
measure: Oxidative stress in sperm sample
timeFrame: At day of ovum pick-up
Locations:
city: Linköping
country: Sweden
facility: University Hospital
state: Östergötland
Study officials:
References: