Меню
Идёт набор NCT05343572

Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium

Ранняя фаза I С лечением Asherman Syndrome Atrophic Endometrium Recurrent Implantation Failure

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: Plerixafor.
Кому может быть актуально
Состояния в реестре: Asherman Syndrome, Atrophic Endometrium, Recurrent Implantation Failure. Базовые параметры: 18 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 →
Официальное название

Bone Marrow Derived Stem Cells Mobilization for Treatment of Asherman's Syndrome, Atrophic Endometrium, and Recurrent Implantation Failure

Обзор

This study will assess the use of autologous bone marrow stem cells mobilization using 1,1'-\[1,4-phenylenebis-(methylene)\]-bis-1,4,8,11-tetraazacyclotetradecane (PLERIXAFOR) as an effective medical therapy for the treatment of Asherman's Syndrome (AS), Atrophic Endometrium (AE) and Recurrent Implantation Failure (RIF).

Подробное описание

This study will assess the use of autologous bone marrow stem cells mobilization using 1,1'-\[1,4-phenylenebis-(methylene)\]-bis-1,4,8,11-tetraazacyclotetradecane (PLERIXAFOR) as an effective medical therapy for the treatment of Asherman's Syndrome (AS), Atrophic Endometrium (AE) and Recurrent Implantation Failure (RIF).

Primary Objective:

* To compare endometrial thickness and implantation rates in women with AS, AE, and RIF receiving PLERIXAFOR compared to historic controls that received existing standard of care therapy * To compare ongoing pregnancy and live birth rates in women with AS, AE, and RIF receiving PLERIXAFOR compared to historic controls that received existing standard of care therapy

Secondary Objectives: (assessed in participants who have not achieved pregnancy as of the timepoint):

\- Endometrial thickness prior to treatment with PLERIXAFOR compared to endometrial thickness 3 and 6 months after treatment.

During this study, participants are asked to:

* Refrain from use of non-steroidal anti-inflammatory drugs (NSAIDs) from 2 weeks prior to the start of the surgery/PLERIXAFOR administration, and for the 30 days following surgery/ PLERIXAFOR administration. * Abstain from intercourse for three months following surgery/PLERIXAFOR administration

* Assessment of menstrual bleeding pattern before and 3 and 6 months following treatment with PLERIXAFOR * Assessment of endometrial blood flow before and 3 and 6 months following treatment with PLERIXAFOR * Assessment of endometrial histology three months following treatment with PLERIXAFOR The study intervention consists of administration of PLERIXAFOR the evening prior to scheduled standard of care surgery for women with AS, AE or RIF, for peripheral mobilization of stem cells. PLERIXAFOR is administered via the subcutaneous route, as a single dose of 20mg.

The goal of this study is to determine if the administration of PLERIXAFOR for autologous, peripheral stem cell mobilization and administration will restore endometrial function in women with AS, AE, and RIF, and allow for pregnancy implantation.

Вмешательства

  • Препарат Plerixafor
    A 20mg single dose of PLERIXAFOR is administered subcutaneously the evening prior to scheduled standard of care surgery for women with AS, AE or RIF for peripheral mobilization of stem cells. For subjects weighing \>83 kilogram, the dosing is a single dose of 0.24 milligram per kilogram.

Первичные конечные точки

  • Change in endometrial thickness and implantation rates following treatment with Plerixafor at 6 month intervals up to 24 months, compared to controls [Срок оценки: Every 6 months from baseline up to 24 months]
Вторичные конечные точки (3)
  • Change in endometrial thickness and implantation rates with Plerixafor in women with AS, AE and RIF at 3 month intervals, compared to baseline/pre-treatment [Срок оценки: Every 3 months from baseline up to 24 months]
  • Difference in ongoing pregnancy and live birth rates in women with AS, AE and RIF following treatment with Plerixafor at 3 month intervals, compared to baseline/pre-treatment [Срок оценки: Every 3 months from baseline up to 24 months]
  • Change in endometrial thickness from baseline after treatment with Plerixafor at month 3 and month 6 for participants that have not achieved pregnancy as of the timepoint [Срок оценки: baseline, month 3 and month 6]

Критерии участия

Критерии включения

  • Healthy, non pregnant females
  • ages ≥18 and ≤40 years old at time of enrollment
  • with either AS, AE, or RIF
  • For AS: surgical history of intrauterine trauma/infection, hypo/amenorrhea, intra-uterine adhesions
  • for AE: US documentation of persistent, <6mm endometrial thickness
  • for RIF: failure to achieve a clinical pregnancy after transfer of at least four good-quality embryos in a minimum of three fresh or frozen cycles in a woman under 40 years and currently being treated at Yale Fertility Clinic

Критерии исключения

  • Presence of hydrosalpinx (diagnosed by radiographic or ultrasound imaging)
  • Endometriosis (diagnosed by previous surgery,)
  • Diminished ovarian reserve (AMH<1ng/ml or follicle stimulating hormone (FSH)>10)
  • History of genital tuberculosis or any ultrasound evidence of congenital uterine anomaly
  • Submucous or intracavitary fibroid, polyps
  • Currently pregnant
  • Personal history of thrombophilia or sickle cell disease
  • Inability to provide informed consent

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
  • Yale Fertility Center — Orange

Идентификаторы

NCT: NCT05343572 · 2000026217 · No NIH funding

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗