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Идёт набор NCT05951075

Prospective Study on Power Prenatal Vitamins for Males on YO Score At-home Sperm Test Results

Без фазы С лечением Spermatogenesis and Semen Disorders Infertility, Male

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: Power Prenatal for Sperm.
Кому может быть актуально
Состояния в реестре: Spermatogenesis and Semen Disorders, Infertility, Male. Базовые параметры: 18 лет — 50 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
США
Следующий шаг
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Официальное название

The Impact of Power Prenatal Supplements for Males on YO Score At-home Sperm Test Results Over a Three Month Course

Обзор

Male factor infertility is a leading cause of primary and secondary infertility. Poor sperm quality is defined as having an abnormal semen analysis. There are now options to assess sperm quality with at-home sperm analysis kits, including an FDA approved Yo Sperm kit (https://yospermtest.com/) which analyzes the motile sperm concentration \[concentration (millions / ml) x motility (Percentage motile)\] and sperm quality (YO Score) which compares your results to laboratory standards and to other men who have fathered children. The effects of supplements (vitamins, minerals, and anti-oxidants) on improving sperm quality are still debated. Taking additional supplements to improve sperm quality represent a modifiable risk-factor that would be an easy intervention for patients struggling with male factor infertility. The life cycle of sperm production is estimated at 3 months, so any intervention would require a 3 month course to see its full effect. The investigators hypothesize that a 90 day course of the "Power Prenatal for Sperm", a male fertility supplement by Bird\&Be (https://birdandbe.com/the-power-prenatal-for-sperm) will improve sperm quality (YO Score) after taking the supplements.

Подробное описание

Male patients that used the FDA approved YO Sperm at-home sperm analysis kit, and were identified with a low YO Score result (20-40) will be potential candidates for this study.

An automated message about a potential research study for patients with a low YO Score results (20-40) will be sent to YO Sperm users. Interested participants will sign up to learn more about the research study. They will be prompted to complete further screening questions to ensure they're eligible study candidates (including inclusion and exclusion criteria, as well as primary residence country and province / state).

All study participants will be provided with IRB-approved study information materials and informed consent documents.

Once approved, and consented to participate, they will receive 3 months of The Power Prenatal for Males (https://birdandbe.com/collections/male-fertility/products/power-prenatal-vitamins-for-males) and re-evaluate the YO Score results monthly for 3 consecutive months after starting the supplements.

The monthly YO Scores will be compared between baseline, month 1, month 2 and month 3. YO Sperm's app will enable study participants to share results (YO Score) with the research team at each assessment. All data will be stored by the study sponsor in a secure and private manner compliant with HIPAA.

Вмешательства

  • Пищевая добавка Power Prenatal for Sperm
    A prenatal vitamin complex that includes numerous ingredients aim at improving sperm quality (ingredients: https://birdandbe.com/the-power-prenatal-for-sperm

Первичные конечные точки

  • YO Sperm Score [Срок оценки: The YO Scores will be compared between baseline (prior to intervention) and after 3 months]

Критерии участия

Критерии включения

  • Male patients with at-home YO Sperm score between 20-40, corresponding to a MSC (motile sperm concentration) between 14-39 motile million / ml
  • Ages 18-50
  • Living in USA or Canada

Критерии исключения

  • Active smokers
  • A known cause of male infertility (eg diagnosed varicocele, hormonal issue, history of testicular surgery, history of chemotherapy, etc)
  • Not concurrently taking other forms of prenatal vitamins

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Medical Electronic Systems — Encino

Публикации

  • Salas-Huetos A, Rosique-Esteban N, Becerra-Tomas N, Vizmanos B, Bullo M, Salas-Salvado J. The Effect of Nutrients and Dietary Supplements on Sperm Quality Parameters: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Adv Nutr. 2018 Nov 1;9(6):833-848. doi: 10.1093/advances/nmy057. PMID 30462179

Идентификаторы

NCT: NCT05951075 · BirdandBe

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗