Идёт набор NCT06122207

Effect of a Probiotic on the Female Genital Tract Microbiota of Participants With Fertility Disorders.

Без фазы С лечением Fertility Disorders

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: Probiotic, Placebo.
Кому может быть актуально: Состояния в реестре: Fertility Disorders. Базовые параметры: 18 лет — 45 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Португалия, Испания
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

A Randomized, Double-blind, Placebo-controlled Study to Confirm the Positive Effect of Fertibiome® (Ligilactobacillus Salivarius PS11610) on the Female Genital Tract Microbiota of Couples or Women With Fertility Disorders.

Обзор

In the last decades, numerous publications have broken the old paradigm that considered the urogenital tracts as sterile, demonstrating that microorganisms present in the urogenital tract represent the 9% of the whole human microbiome. Healthy urogenital microbiome improves implantation rate and pregnancy outcomes, whereas 40% of dysbiosis prevalence is observed in women under assisted reproductive treatment (ART). Infertility causes are associated with male, female, or combined failure. It has been shown that oral probiotic treatment, mainly with Lactobacillus, recovers a healthy vaginal microbiota without safety concerns. An interventional, randomized, double-blind, placebo-controlled study will be conducted to confirm the positive effect of the commercial probiotic product Fertibiome® on the vaginal dysbiosis of couples or women with fertility disorders. The duration of the study will be of 6 months approximately, including 6 months of product intake. In case of pregnancy during intervention, women will continue their participation until week 12 of gestation. Participants will be randomly assigned to one of the two study groups: control group with placebo administration or probiotic administration group. Women will take 1 capsule every 12 hours and men 1 per day. In case of women participating alone they will take 1 capsule every 12 hours. In case of pregnancy, only women will continue taking 1 capsule per day for the first 12 weeks.

Вмешательства

Пищевая добавка Probiotic
* Women: 1 capsule of probiotic (Ligilactobacillus salivarius PS11610) every 12 hours for 6-months. In case of pregnancy: * Women: 1 capsule of probiotic per day for 12 weeks. * Men: 1 capsule of probiotic (Ligilactobacillus salivarius PS11610) per day for 6-months.
Пищевая добавка Placebo
* Women: 1 capsule of placebo every 12 hours for 6-months. In case of pregnancy: * Women:1 capsule of placebo per day for 12 weeks. * Men: 1 capsule of placebo per day for 6-months.

Первичные конечные точки

Percentage (%) of women with vaginal dysbiosis after 3 months of treatment. [Срок оценки: After 3 months of intervention.]
Percentage (%) of women with vaginal dysbiosis after 6 months of treatment. [Срок оценки: After 6 months of intervention.]

Вторичные конечные точки (12)

Number of vaginal dysbiosis criteria in case of pregnancy confirmation. [Срок оценки: Up to 6 months.]
Percentage (%) of women with vaginal dysbiosis. [Срок оценки: Before intervention.]
Number of dysbiosis criteria per woman. [Срок оценки: Before intervention.]
Number of dysbiosis criteria per woman. [Срок оценки: After 3 months of treatment pregnancy confirmation.]
Number of dysbiosis criteria per woman. [Срок оценки: After 6 months of treatment or pregnancy confirmation.]
Percentage of Lactobacillus in vaginal microbiota. [Срок оценки: Before intervention.]
Percentage of Lactobacillus in vaginal microbiota. [Срок оценки: After 3 months of treatment or pregnancy confirmation.]
Percentage of Lactobacillus in vaginal microbiota. [Срок оценки: After 6 months of treatment or pregnancy confirmation.]
Number of reproductive treatments during the study period. [Срок оценки: After 6 months of treatment or pregnancy confirmation.]
Pregnancy rate. [Срок оценки: After 6 months of treatment or pregnancy confirmation.]
Time elapsed from the beginning of the study, until the occurrence of pregnancy. [Срок оценки: Up to 6 months.]
Spontaneous pregnancy rate, not associated to fertility treatment (IVF or AI). [Срок оценки: Up to 6 months.]

Критерии участия

Критерии включения

Couples or women with ages between 18 and 45 for woman and between 18 and 55 for man (in case of couple participation).
Couples or women with fertility disorders.
Couples or women undergoing IVF treatment or willing to start it.
Signature of the Informed Consent.

Критерии исключения

Women, not participating in the study with a couple, who have not undergone at least 4 cycles of artificial insemination with donor's sperm (AID) or 1 cycle of IVF without achieving evolutionary pregnancy.
Women with Body Mass Index (BMI) ≥ 30.
Couples where the woman has not infertility diagnosis while the man has any of the following characteristics:

Azoospermia
Sperm motility (A + B) < 25%.
Sperm morphology ≤ 2%.
Vas deferens obstruction.
Couples or women with any of the following characteristics:

Chronic diseases that cause intestinal malabsortion.
Congenital or acquired immunodeficiency.
Current history or diagnosis of alcohol, tobacco, or drug abuse.
Uncertainty about the willingness or ability of participants to comply with the requirements of the protocol.
Under treatment with probiotics during the last week.

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

Здоровые добровольцы: Нет