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

Not Applicable

Recruiting

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

• Registration Number: NCT06831292
• Lead Sponsor: Ostergotland County Council, Sweden

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.

Study Timeline

• Study First Submitted: 2024-09-17
• Study Start: 2024-12-26
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-14
• Last Update Submitted: 2025-02-17
• Study First Posted: 2025-02-18
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sperm RNA profile changes	At day at ovum pick-up	Small RNA profiling and sequencing will be performed on sperm cells provided by participant at the start of controlled ovarian hormone stimulation of partner and at time of ovum pick-up and compared between the intervention groups.
Sperm total count	At day of ovum pick-up	Sperm total count in millions, assessed by sperm analysis
Sperm concentration	At day of ovum pick-up	Sperm concentration assessed by sperm analysis in millions/ml, with total sperm count in millions, divided by semen volume assessed in ml.
Sperm sample analysis	At day of ovum pick-up	Sperm motility assessed, proportion of motile sperm to total amount of sperm, reported in percent

Secondary Outcome Measures

Name	Time	Method
Fertilization rate	Day one after ovum pick-up	Number of normally fertilised oocytes, assessed as proportion of total number of oocytes retrieved (percent)
High quality embryo rate	Day 6 after ovum pick-up	Number of high quality embryo in relation to total number of oocytes fertilised
Embryos frozen	Day 5 and/or 6 after ovum pick-up	Number of good quality embryos frozen
Clinical pregnancy rate	Assessed 5-7 weeks after ovum pick-up	Defined by viable intra-uterine pregnancy at ultrasonography in gestational week 7-9
Pregnancy rate	Assessed three weeks after ovum pick-up	Positive pregnancy test in urine (hCG) after IVF

Trial Locations

Locations (1)

University Hospital; 🇸🇪 Linköping, Östergötland, Sweden