The Effects of Diet on Small Non-coding RNA I Sperm Cells and the Possible Effects on Reproductive Success: Diet Intervention Effects on Sperm (DIET-IS)

Ostergotland County Council, Sweden

Status: Enrolling

Conditions: Male Fertility; Changes in SncRNA in Sperm; RNA Profile

Treatments: Dietary Supplement: Diet intervention NMR

Study type: Interventional

Funder types: Other

Identifiers

NCT06831292

RÖ-961659 substudy 3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 23 to 56 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Diet intervention- Nordic nutrition recommendations

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Diet intervention NMR

No diet intervention

No Intervention group

Description:

No intervention - this group will only receive standard care