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Идёт набор NCT07111247

Insights in Endocervical Mucus Secretion

Фаза IV С лечением Cervical Mucus

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: Gonadotropin Releasing Hormone Antagonists Relugolix.
Кому может быть актуально
Состояния в реестре: Cervical Mucus. Базовые параметры: 21 лет — 40 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Single arm interventional study looking at biological outcomes at 4 time points throughout the cycle before and after taking an oral gonadotropin-releasing hormone antagonist (gnRH). Samples of whole blood, endocervical mucus, endocervical biopsy, and vaginal swab will be collected.

Подробное описание

This study will enroll participants and obtain biological samples at 4 time points. The study will begin on the first day of menstruation following enrollment. Patients will monitor for peri-ovulation using an ovulation test that monitors for urinary metabolites for luteinizing hormone (LH). At the midluteal time point for sampling (days 6-9 after "high fertility" on ovulation test) subjects will begin taking an oral gonadotropin-releasing hormone antagonist (gnRH) (relugolix) for 10 days. Samples of whole blood, endocervical mucus, endocervical biopsy, and vaginal swab will be collected during the early follicular phase (3-5 days following the start of menstruation), peri-ovulation (9-14 days following the start of menstruation based on estriol glucuronide (E3G) urinary metabolite), mid-luteal (6-9 days following mid-cycle draw), and upon stoppage of relugolix (9-11 days following relugolix initiation).

Вмешательства

  • Препарат Gonadotropin Releasing Hormone Antagonists Relugolix
    Gonadotropin releasing hormone antagonist (gnRH) taken for 10 days starting during the midluteal phase.

Первичные конечные точки

  • Cervical mucus scores [Срок оценки: Cervical mucus will be collected and compared across 4 time points during the menstrual cycle (follicular [3-5 days following start of menses], ovulatory, luteal, ovarian suppression [9-11 days following Relugolix initiation])]
  • Single cell transcriptome analysis [Срок оценки: Measured and compared across 4 time points during the menstrual cycle (follicular [3-5 days following start of menses], ovulatory, luteal, ovarian suppression [9-11 days following Relugolix initiation])]
  • Proteomic analysis [Срок оценки: Measured and compared across 4 time points during the menstrual cycle (follicular [3-5 days following start of menses], ovulatory, luteal, ovarian suppression [9-11 days following Relugolix initiation])]

Критерии участия

Критерии включения

  • Normal menstrual cycles of 25-35 days in length for at least the previous 3 cycles
  • BMI >18 and <35
  • Serum p4 >= 3 ng/ml on single sample collected between days 18-25 of self-reported menstrual cycle
  • Flexible schedule allowing blood draws on less than 48 hour notice
  • In good general health
  • Commit to using non-hormonal contraceptive methods without spermicide during study period except those prescribed in the experimental protocol
  • No objections to taking study drugs
  • No objections to refraining from intercourse the night before any sampling and willing to use condoms during vaginal intercourse

Критерии исключения

  • Oral contraceptive use or other hormone supplement within the preceding 2 months
  • Current cervical infection
  • Evidence of abnormal cervical cytology
  • Use of any IUD for contraception
  • Long-acting hormonal contraceptive use in the past 12 months (e.g., Depo-Provera)
  • Contraindications to study drugs
  • Current or past pregnancy within the previous 6 months or currently trying to conceive
  • Desiring to conceive in the next 8 months
  • Breastfeeding in the past 2 months
  • Diagnosed diabetes or metabolic syndrome
  • Diagnosed Polycystic Ovary Syndrome
  • History of, or self-reported, substance abuse
  • Smoker
  • Previous infertility treatment excluding male factor issues
  • Use of an investigational drug within the past 2 months
  • History of excisional or ablative treatment procedure on cervix (i.e., LEEP, Cryotherapy, Cold Knife Cone)
  • Current treatment for a vaginal infection such as bacterial vaginosis
  • History of venous thromboembolism (VTE) or inherited thrombophilias

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
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Oregon Health & Science University — Portland

Идентификаторы

NCT: NCT07111247 · STUDY00028821 · R01HD115770-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗