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Набор скоро начнётся NCT06721273

Iodine Supplementation and Fertility Parameters

Без фазы С лечением Infertility (IVF Patients)

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: Iodine, Placebo.
Кому может быть актуально
Состояния в реестре: Infertility (IVF Patients). Базовые параметры: 18 лет — 45 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
Список центров уточняется — проверьте первичный протокол.
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

The Effect of Iodine Supplementation on Fertility Parameters in Women Experiencing Infertility

Обзор

Iodine has been identified as a potential factor influencing female fertility during the childbearing years. The American Thyroid Association recommends that women attempting to conceive take a supplement containing 150 µg of iodine. However, no clinical trials have specifically examined the necessity of iodine supplementation in women experiencing infertility. Furthermore, no information is available on the optimal dose and duration of iodine supplementation to increase the chances of successful treatment in this group of women. Therefore, this study aims to investigate the effects of iodine supplementation on fertility parameters in infertile women.

Подробное описание

This double-blind randomized clinical trial will be conducted in infertility clinic on women with diminished ovarian reserve and undergoing in vitro fertilization (IVF) cycle treatment. According to the Bologna criteria, decreased ovarian reserve is defined as having 3 to 5 antral follicles and an anti-Müllerian hormone concentration ranging from 0.1 to 1.5 ng/ml. All women diagnosed with diminished ovarian reserve who meet the inclusion and exclusion criteria outlined in the general information section of the clinical trial and have provided written consent to participate will be examined. Following enrollment and baseline measurements, women will be randomly assigned to treatment groups-placebo and iodine supplement (150 µg/day of iodine)-in a 1:1 allocation ratio, using a random number table. In the intervention group, women will take 150 µg of iodine daily (one tablet per day, Tavan Institute, Tehran, Iran) for two months prior to starting the new IVF cycle. In the control group, participants will take a placebo tablet daily (containing white wheat flour, designed to match the size, shape, and color of the iodine tablet, Tavan Institute, Tehran, Iran) for the same duration before beginning the new IVF cycle. Women of two groups will be followed until the end of IVF cycle. Women in both groups will be monitored until the completion of the IVF cycle. Throughout the study, the following parameters will be assessed based on the timeline of the IVF cycle: the number of retrieved oocytes, the number of mature (MII) oocytes, the number of embryos, embryo quality, biochemical pregnancy, and clinical pregnancy.

Вмешательства

  • Пищевая добавка Iodine
    In intervention group women will take 150 µg daily (one tablet per day, Tavan Institute, Tehran, Iran) that will be 2 months before starting the new in vitro fertilization (IVF) cycle.
  • Пищевая добавка Placebo
    Women will take a placebo tablet daily (containing white wheat flour, which is similar to iodine table in terms of size, shape, and color, Tavan Institute, Tehran, Iran) 2 months before starting the new IVF cycle.

Первичные конечные точки

  • Number of retrieved oocytes [Срок оценки: 2 weeks after the start of ovarian stimulation (approximately 2 months after intervention)]
  • Number of mature (MII) oocytes [Срок оценки: 2 weeks after the start of ovarian stimulation (approximately 2 months after intervention)]
Вторичные конечные точки (4)
  • Number of embryos [Срок оценки: 16-18 hours after insemination]
  • Quality of embryos [Срок оценки: 3 days after fertilization]
  • Biochemical pregnancy [Срок оценки: 12 days after embryo transfer]
  • Clinical pregnancy [Срок оценки: 3 weeks after embryo transfer]

Критерии участия

Критерии включения

  • Women with diminished ovarian reserve
  • Willingness to participate
  • Age range: 18 to 45 years
  • Women with a menstrual cycle of 21 to 42 days
  • Women who have not used any contraceptive methods in the past 12 months
  • Women who have not had in sexual intercourse for more than 2 months

Критерии исключения

  • Unwillingness to participate
  • Women with polycystic ovary syndrome or endometriosis
  • Diagnosis of any thyroid disease
  • Use of any medication that affects the thyroid function
  • Use of dietary supplements containing iodine (excluding those considered in the present study)
  • Use of iodine-containing disinfectants

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06721273 · 1402-4-418-69386

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗