Идёт набор 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

Без фазы С лечением Changes in sncRNA in Sperm Male Fertility RNA Profile

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Diet intervention NMR.
Кому может быть актуально: Состояния в реестре: Changes in sncRNA in Sperm, Male Fertility, RNA Profile. Базовые параметры: 23 лет — 56 лет · Мужчины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Швеция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Molecular Mechanisms for Male Fertility: Can Diet Change Sperm sncRNA and the Reproductive Potential?

Обзор

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.

Подробное описание

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.

Вмешательства

Пищевая добавка Diet intervention NMR
Participants will receive groceries to their homes with planned recipes. The recipes are planned by using the Nordic nutrition councils recommendations.

Первичные конечные точки

Sperm RNA profile changes [Срок оценки: At day at ovum pick-up]
Sperm total count [Срок оценки: At day of ovum pick-up]
Sperm concentration [Срок оценки: At day of ovum pick-up]
Sperm sample analysis [Срок оценки: At day of ovum pick-up]

Вторичные конечные точки (5)

Fertilization rate [Срок оценки: Day one after ovum pick-up]
High quality embryo rate [Срок оценки: Day 6 after ovum pick-up]
Embryos frozen [Срок оценки: Day 5 and/or 6 after ovum pick-up]
Clinical pregnancy rate [Срок оценки: Assessed 5-7 weeks after ovum pick-up]
Pregnancy rate [Срок оценки: Assessed three weeks after ovum pick-up]

Критерии участия

Критерии включения

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