Меню
Набор по приглашению NCT07523022

Comparison of the Effect of Gonadotropin and Clomiphene Citrate Treatment on Sperm Parameters and the Outcome of Assisted Reproductive Procedures in Subfertile Men Based on the APHRODITE Groups

Фаза IV С лечением Male Infertility

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: recFSH, HCG injection, Clomiphene Citrate 50 mg.
Кому может быть актуально
Состояния в реестре: Male Infertility. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Венгрия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Men enrolled in the study are assigned to each APHRODITE group. Group 2,3,4 are treated with either gonadotropin preparations or clompihene-citrate (except group 4). The type of the treatment (gonadotropin vs clomiphene) is randomized. After treatment, hormonal measurements, spermiogram and DNA fragmentation tests are repeated, allowing for analysis of the outcome.

Подробное описание

Our research involves male partners of couples suffering from male infertility. After a comprehensive andrological examination, based on the test results, the men are classified into so-called "APHRODITE" categories. Based on these categories, half of the patients are given so-called gonadotropin treatment (the exact treatment depends on the type of category), which involves subcutaneous injections several times a week for a total of 12 weeks. The other half of the patients are recommended oral tablets containing the active ingredient clomiphene citrate, also for 12 weeks. It is important that both types of therapy (gonadotropin and clomiphene citrate) are effective treatments in certain cases of male infertility, according to the literature, so all patients participating in the research receive effective treatment. However, it is decided who receives which treatment by randomization.

After the 12-week treatment, a control sperm analysis and a DNA fragmentation test are performed to determine the success of the treatment (changes in sperm analysis results and DNA fragmentation index).

The improvement in sperm parameters will be determined in the two treatment regimens, the rate of fertilized eggs in subsequent assisted reproduction cycles, the quality of the resulting embryos, and the rate of pregnancies and subsequent losses. The results of the two therapeutic modalities will be compared, so that it can be decided which treatment method is more effective.

The research process is essentially as follows:

1. information, examination 2. classification into the APHRODITE category based on the results 3. randomization (gonadotropin or clomiphene citrate) 4. injection treatment for patients in the gonadotropin group, with therapy according to the APHRODITE category for 12 weeks 5. tablet treatment for patients in the clomiphene citrate group for 12 weeks 6. control spermiogram and DNA fragmentation 7. analysis of the results of subsequent assisted reproduction procedures

Вмешательства

  • Препарат recFSH
    recFSH 3x150NE sc weekly for 12 weeks
  • Препарат HCG injection
    hCG 2x5000NE sc weekly for 12 weeks
  • Препарат Clomiphene Citrate 50 mg
    clompihene-citrate 50mg p.o. daily for 12 weeks

Первичные конечные точки

  • sperm DNA fragmentation [Срок оценки: 12 weeks of treatment]
  • ejaculate volume [Срок оценки: 12 weeks of treatment]
  • sperm concentration [Срок оценки: 12 weeks]
  • sperm motility [Срок оценки: 12 weeks]
  • total sperm count, total functional sperm count [Срок оценки: 12 weeks]
  • Sperm morphology [Срок оценки: 12 weeks]
Вторичные конечные точки (4)
  • gonadotropin vs clomiphene - total sperm count, total functional sperm count [Срок оценки: 12 weeks of treatment]
  • gonadotropin vs clomiphene - DNA fragmentation [Срок оценки: 12 weeks]
  • Gonadotropin vs clomiphene - sperm total motility, progressive motility [Срок оценки: 12 weeks]
  • gonadotropin vs clomiphene - normal sperm morphology [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • abnormal sperm analysis result, APHRODITE 2,3,4 categories

Критерии исключения

  • obstructive azoospermia
  • non-obstructive azoospermia due to genetical defects (Klinefelter-syndrome, AZFa, AZFb microdeletion syndrome etc)
  • problems with the administration of subcutaneous injections
  • disagreement

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
Простое слепое
Основная цель
Лечение

Центры проведения

Венгрия · 1 центр
  • Reproductive Medicine Centre, Department of Obstetrics and Gynecology, University of Szege — Szeged

Идентификаторы

NCT: NCT07523022 · NNGYK943

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗