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Идёт набор NCT07083999

Observational Study to Evaluate Fertility in Women Between 32 and 38 Years Old Treated With the Ovosicare® Fertility

— Наблюдательное Fertility

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Fertility. Базовые параметры: 32 лет — 38 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
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

Prospective Observational Study to Evaluate Fertility in Women Between 32 and 38 Years Old Treated With the Ovosicare® Fertility Food Supplement Containing a Combination of MYO/DCI in a 3.6:1 Ratio, Antioxidants, Vitamins and Minerals

Обзор

The goal of this observational study is to evaluate whether supplementation with the Ovosicare® Fertility food supplement increases the possibility of becoming pregnant in women aged between 32 and 38 years who have been trying to become pregnant for at least 6 months before starting supplementation.

Подробное описание

The duration of participation in the study for each patient will be a maximum of 18 months. This follow-up period may be shorter if a pregnancy occurs.

The number of visits throughout the study will be a total of three. Please note that you will not have to undergo additional tests or attend any extraordinary visits due to participating in this study, since the procedures you will undergo are the same as those routinely carried out in clinical practice.

Первичные конечные точки

  • Evaluate the rate of spontaneous pregnancy in women between 32 and 38 years old after a maximum of 6 months of supplementation with Ovosicare Fertility [Срок оценки: From enrollment to visit 2 (9 months)]
Вторичные конечные точки (11)
  • Evaluate the time until spontaneous clinical pregnancy [Срок оценки: From enrollment to visit 2 (9 months)]
  • Evaluate changes in analytical parameters in blood: Biochemistry panel [Срок оценки: From enrollment to visit 2 (9 months)]
  • Evaluate changes in analytical parameters in blood: Hormonal panel [Срок оценки: From enrollment to visit 2 (9 months)]
  • Evaluate changes in karyotype [Срок оценки: From enrollment to visit 2 (9 months)]
  • Evaluate the presence of anatomy changes by ultrasound test [Срок оценки: From enrollment to visit 2 (9 months)]
  • To evaluate changes in the number of antral follicle by ultrasound test [Срок оценки: From enrollment to visit 2 (9 months)]
  • Evaluate the safety profile of Ovosicare Fertility [Срок оценки: From enrollment to 6months (during sumplementation)]
  • Ovosicare Fertility tolerability degree [Срок оценки: From enrollment to 6 months (during sumplementation)]
  • Ovosicare Fertility use satisfaction degree [Срок оценки: From enrollment to 6 months (during sumplementation)]
  • Ovosicare Fertility Adherence [Срок оценки: From enrollment to 6 months (during sumplementation)]
  • Live birth rate [Срок оценки: After 9 moths after pregnancy confirmation]

Критерии участия

Критерии включения

  • \- Women who agree to participate in the study by signing the informed consent.
  • \- Between 32 and 38 years old.
  • \- Who come to doctor´s office stating that they have been trying to get pregnant for at least 6 months.

Критерии исключения

  • \- BMI > 30 kg/m2.
  • \- Existence of severe male factor subfertility according to the criteria of the World Health Organization (WHO), with at least one analysis obtained in the last 6 months with one or more variables with values of:
  • Azoospermia
  • Progressive motility <25%
  • Normal morphology ≤2%
  • \- Pregnant or breastfeeding women.
  • \- Patients with type 1 diabetes or thyroid disease.
  • \- Patients with any assisted reproduction technique scheduled during the duration of the study.
  • \- Patients who have used or taken systemic steroids, anticonvulsants, antiretroviral treatment for HIV or hepatitis B in the last month.
  • \- Patients with a known allergy to any of the components of Ovosicare® Fertility.
  • \- Any other situation that, in the medical opinion, advises against treatment with Ovosicare® Fertility or that may make patient follow-up difficult.
  • \- Patients with suspected endometriosis.
  • \- Existence of fibroids affecting the endometrial cavity.
  • \- Patients with 2 or more previous abortions.
  • \- Patients with a current diagnosis of a high-risk human papillomavirus (HPV) cervical lesion.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Испания · 27 центров
  • CM Sitges — Sitges
  • HU de Getafe — Getafe
  • Clínica Rv Benalmádena — Benalmádena
  • H García Orcoyen — Estella-Lizarra
  • CP Dr. Andrade Andrade — A Coruña
  • CP Dra. Domenech Casanova — Alicante
  • H Vega Baja de Orihuela — Alicante
  • Clinica Alboran — Almería
  • … и ещё 19 центров

Идентификаторы

NCT: NCT07083999 · FERTILOBS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗