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Набор скоро начнётся NCT06769789

Evaluation of Pregnancy Outcome with Usage of Drug-free In-vitro Activation of Follicles Ovary

Без фазы С лечением Infertility (IVF Patients) Infertile Females or Females with Ovarian Insufficiency

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: Drug free invitro activation Ovary.
Кому может быть актуально
Состояния в реестре: Infertility (IVF Patients), Infertile Females or Females with Ovarian Insufficiency. Базовые параметры: 21 лет — 35 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 →
Официальное название

Evaluation of Pregnancy Outcome in Poor Responder Patients in IVF Cycle with Usage of Drug-free In-vitro Activation of Follicles Ovary

Обзор

This study is the pilot study to evaluate the effect of Drug-free in vitro activation to improve the outcomes of IVF in poor responder women

Подробное описание

First, patients who are poor responders based on Poseidon criteria 1, 3 (women under 35 years of age who either have abnormal ovarian reserve tests or have not had an adequate ovarian response in an IVF cycle) are included in the list of poor responders and are consulted after a complete evaluation by a physician. The patient has a history of poor response in previous IVF cycles. After obtaining the patient's consent, the patient undergoes laparoscopy. The laparoscopy procedure will be performed at Milad Infertility Center, which is equipped with a laparoscopy operating room and a laboratory nearby. The procedures will be performed by a single surgical team that includes laparoscopy and infertility flowsheets. After general anesthesia and pre- and post-operative care, double puncture laparoscopy will be performed. Two minor trocars will be placed, which will be held in place by an ovarian grasper. With scissors, a part of the ovarian cortex is first separated from the underlying medulla and strips of cortex 1 to 2 mm thick and 10 mm long are removed. They are immediately transferred to the adjacent laboratory. A 1 x 5 mm sample from the removed piece is used for histological examination and determination of the number of remaining follicles. The tissue is then divided into 1 x 1 x 1 mm pieces. The removal site will be sutured in case of bleeding. The preparation of the ovary into small pieces will be performed by a single physician for all patients. The prepared pieces are immediately transferred to the operating room. Then the surgeon places the prepared pieces in the tunnel between the cortex and medulla in the opposite ovary and then sutured. The patient is then followed up and immediately treated with FSH (Sinagene Company, Tehran, Iran) at a maximum dose of 300 units, and then the dose is adjusted according to the ovarian response. When a 12 mm follicle is observed, 0.25 mg of Sterotide (Merck Serono, Mississauga, Canada) is started. When the size of 1 or 2 follicles reaches 16, 10,000 units of HCG (Puyish Daru Company, Tehran, Iran) and two ampoules of Deca (Decapeptyl 0.2 mg, Ferring, Germany) are given together for triggering. Ovulation is performed 36 hours later under transvaginal ultrasound guidance.

Вмешательства

  • Другое Drug free invitro activation Ovary
    Drug free invitro activation Ovary

Первичные конечные точки

  • The number of oocytes obtained at oocyte pick-up (OPU) [Срок оценки: Within 3 weeks after ovarian stimulation]
  • Number of embryos [Срок оценки: Within 3 weeks after ovarian stimulation]
  • Quality of embryos at the end of IVF treatment [Срок оценки: Within 3 weeks after ovarian stimulation]
Вторичные конечные точки (3)
  • Implantation rate [Срок оценки: 4-8 weeks after transfer]
  • Clinical pregnancy rate [Срок оценки: one month after transfer]
  • Miscarriage rate [Срок оценки: 20 weeks after transfer]

Критерии участия

Критерии включения

  • Women under 35 years of age who have one of the following characteristics:

Or poor response to gonadotropins in a previous IVF cycle (fewer than 3 oocytes in a previous IVF cycle)

Or ovarian reserve test AMH less than 1.1

Критерии исключения

  • Unwillingness to continue working with the researcher during the procedure

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06769789 · IR.MUMS.IRH.REC.1403.127

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗