Ovulation Trigger Strategies in Low Ovarian Reserve (TRIGGERBEST) (TRIGGERBEST)
Ovulation Trigger Strategies in Women With Low Ovarian Reserve Undergoing Fresh In Vitro Fertilization Cycles: A Prospective Randomized Controlled Trial (TRIGGERBEST)
This study aims to compare different ovulation triggering strategies in women with low ovarian reserve undergoing fresh in vitro fertilization (IVF) cycles.
Ovulation triggering is a key step in IVF treatment, as it determines final oocyte maturation prior to oocyte retrieval.
Participants are randomly assigned to one of three ovulation trigger approaches: human chorionic gonadotropin (hCG) alone, follitropin delta combined with hCG, or dual trigger using a gonadotropin-releasing hormone (GnRH) agonist plus hCG.
The primary objective is to evaluate wether adding follitropin delta at the time of triggering increases the number of matura oocytes obtained, without adversely affecting implantation rates. Pregnancy otucomes following fresh embryo transfer will also be assessed.
The results of this study may help optimize ovulation triggering strategies in women with low ovarian reserve undergoing IVF treatment.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Final oocyte maturation is a critical step in assisted reproductive techniques (ART) and is largely determined by the ovulation triggering strategy. In women with low ovarian reserve, achieving an adequate number of mature oocytes remains a major challenge, even when established trigger protocols are used.
Dual trigger strategies combining hCG and a GnRH agonist are widely used in this population, based on evidence suggesting improved oocyte maturation. However, despite this approach, oocyte yield and maturity often remain suboptimal. The addition of exogenous follicle-stimulating hormone (FSH) activity at the time of ovulation triggering has been proposed as a potential strategy to further optimize final oocyte maturation.
Follitropin delta has a distinct pharmacokinetic profile and provides individualized FSH exposure based on ovarian reserve markers. Its use in combination with hCG at the time of triggering may enhance oocyte maturation without compromising endometrial receptivity.
This prospective, randomized study compares three ovulation triggering strategies in women with low ovarian reserve undergoing fresh IVF cycles: hCG alone, follitropin delta combined with hCG, and dual triggering using a GnRH agonist plus hCG. Participants are randomly assigned to one of the three groups.
The primary outcome is the number of mature oocytes (metaphase II, MII) obtained at oocyte retrieval. Secondary outcomes include the proportion of mature oocytes, biochemical pregnancy rate per embryo transfer, and ongoing pregnancy rate following fresh embryo transfer.
The study aims to generate evidence to optimize ovulation triggering strategies in women with low ovarian reserve.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 3
Контакты и местонахождение
Контакты исследования
- Имя: Cesar Lizan Tudela
- Номер телефона: +34 96 197 3500
- Электронная почта: cesarlizan@yahoo.es
Места учебы
-
-
-
Valencia, Испания, 46010
- Рекрутинг
- Hospital Clínico Universitario de Valencia
-
Контакт:
- Cesar Lizan Tudela
- Номер телефона: +34 96 197 3500
- Электронная почта: cesarlizan@yahoo.es
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Signed informed consent.
- Women aged between 18 and 42 years.
- Primary infertility.
- Women with low ovarian response classified within one of the groups defined by the POSEIDON criteria.
Exclusion Criteria:
- More than two previous failed ovarian stimulation cycles.
- Female age >42 years.
- Body mass index (BMI) >35 kg/m².
- Criteria of extremely low ovarian reserve according to the Spanish National Health System exclusion criteria (AMH <0.3 ng/mL and/or antral follicle count <5).
- Male partner age >55 years.
- Severe male factor infertility (total motile sperm count <1 million).
- Previous voluntary sterilization (vasectomy or bilateral tubal ligation).
- Previous healthy child shared by the couple.
- Presence of medical conditions contraindicating pregnancy.
- Risk of ovarian hyperstimulation syndrome (OHSS). If more than 15 follicles are expected on the day of trigger, the patient will be excluded from the study.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: hCG alone
Ovulation triggering using human chorionic gonadotropin (hCG) alone.
|
Human chorionic gonadotropin (hCG) administered for final oocyte maturation and ovulation triggering.
Другие имена:
|
|
Экспериментальный: Follitropin delta + hCG
Ovulation triggering using follitropin delta in combination with human chorionic gonadotropin (hCG).
|
Human chorionic gonadotropin (hCG) administered for final oocyte maturation and ovulation triggering.
Другие имена:
Follitropin delta administered as part of the ovulation-triggering regimen for final oocyte maturation. (hCG). |
|
Экспериментальный: Dual trigger
Ovulation triggering using a gonadotropin-releasing hormone (GnRH) agonist in combination with human chorionic gonadotropin (hCG).
|
Human chorionic gonadotropin (hCG) administered for final oocyte maturation and ovulation triggering.
Другие имена:
Triptorelin, a gonadotropin-releasing hormone (GnRH) agonist, administered as part of the ovulation-triggering regimen for final oocyte maturation.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of mature oocytes (MII)
Временное ограничение: During the oocyte retrieval procedure
|
Number of metaphase II (MII) oocytes obtained at oocyte retrieval following ovulation triggering
|
During the oocyte retrieval procedure
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Proportion of mature oocytes
Временное ограничение: During the oocyte retrieval procedure
|
Percentage of metaphase II (MII) oocytes relative to the total number of oocytes retrieved.
|
During the oocyte retrieval procedure
|
|
Biochemical pregnancy rate per embryo transfer
Временное ограничение: 10-14 days after embryo transfer
|
Positive beta-human chorionic gonadotropin (beta-hCG) test following fresh embryo transfer.
|
10-14 days after embryo transfer
|
|
Ongoing pregnancy rate
Временное ограничение: 6-7 weeks of gestation
|
Presence of a viable intrauterine pregnancy confirmed by ultrasound.
|
6-7 weeks of gestation
|
Соавторы и исследователи
Следователи
- Главный следователь: Cesar Lizan Tudela, Department of Obstetrics and Gynaecology, Hospital Clínico Universitario de Valencia
Публикации и полезные ссылки
Общие публикации
- Kale A, Kale A. Oocyte Quality and Blastocyst Formation Rate with Dual Stimulation in Patients Belonging to POSEIDON Groups 3 and 4: A Retrospective Comparative Study. J Obstet Gynaecol India. 2023 Feb;73(1):57-61. doi: 10.1007/s13224-022-01703-1. Epub 2022 Oct 21.
- Zhang Q, He S, Meng Y, Yin T, Ming L, Yang J, Li S. Effect of medroxyprogesterone acetate dose in progestin-primed ovarian stimulation on pregnancy outcomes in poor ovarian response patients with different body mass index levels. Front Endocrinol (Lausanne). 2024 Apr 18;15:1352522. doi: 10.3389/fendo.2024.1352522. eCollection 2024.
- Chern CU, Li JY, Tsui KH, Wang PH, Wen ZH, Lin LT. Dual-trigger improves the outcomes of in vitro fertilization cycles in older patients with diminished ovarian reserve: A retrospective cohort study. PLoS One. 2020 Jul 6;15(7):e0235707. doi: 10.1371/journal.pone.0235707. eCollection 2020.
- Alyasin A, Mehdinejadiani S, Ghasemi M. GnRH agonist trigger versus hCG trigger in GnRH antagonist in IVF/ICSI cycles: A review article. Int J Reprod Biomed. 2016 Sep;14(9):557-566.
- Huang Z, Wells D. The human oocyte and cumulus cells relationship: new insights from the cumulus cell transcriptome. Mol Hum Reprod. 2010 Oct;16(10):715-25. doi: 10.1093/molehr/gaq031. Epub 2010 Apr 29.
- Zhang Y, Yan Z, Qin Q, Nisenblat V, Chang HM, Yu Y, Wang T, Lu C, Yang M, Yang S, Yao Y, Zhu X, Xia X, Dang Y, Ren Y, Yuan P, Li R, Liu P, Guo H, Han J, He H, Zhang K, Wang Y, Wu Y, Li M, Qiao J, Yan J, Yan L. Transcriptome Landscape of Human Folliculogenesis Reveals Oocyte and Granulosa Cell Interactions. Mol Cell. 2018 Dec 20;72(6):1021-1034.e4. doi: 10.1016/j.molcel.2018.10.029. Epub 2018 Nov 21.
- Wissing ML, Kristensen SG, Andersen CY, Mikkelsen AL, Host T, Borup R, Grondahl ML. Identification of new ovulation-related genes in humans by comparing the transcriptome of granulosa cells before and after ovulation triggering in the same controlled ovarian stimulation cycle. Hum Reprod. 2014 May;29(5):997-1010. doi: 10.1093/humrep/deu008. Epub 2014 Feb 7.
- Haas J, Ophir L, Barzilay E, Yerushalmi GM, Yung Y, Kedem A, Maman E, Hourvitz A. GnRH agonist vs. hCG for triggering of ovulation--differential effects on gene expression in human granulosa cells. PLoS One. 2014 Mar 6;9(3):e90359. doi: 10.1371/journal.pone.0090359. eCollection 2014.
- Parks JC, Patton AL, McCallie BR, Griffin DK, Schoolcraft WB, Katz-Jaffe MG. Corona cell RNA sequencing from individual oocytes revealed transcripts and pathways linked to euploid oocyte competence and live birth. Reprod Biomed Online. 2016 May;32(5):518-26. doi: 10.1016/j.rbmo.2016.02.002. Epub 2016 Feb 24.
- Borgbo T, Povlsen BB, Andersen CY, Borup R, Humaidan P, Grondahl ML. Comparison of gene expression profiles in granulosa and cumulus cells after ovulation induction with either human chorionic gonadotropin or a gonadotropin-releasing hormone agonist trigger. Fertil Steril. 2013 Oct;100(4):994-1001. doi: 10.1016/j.fertnstert.2013.05.038. Epub 2013 Jul 12.
- Yu EJ, Choi WY, Park MS, Eum JH, Lee DR, Lee WS, Lyu SW, Yoon SY. RNA sequencing-based transcriptome analysis of granulosa cells from follicular fluid: Genes involved in embryo quality during in vitro fertilization and embryo transfer. PLoS One. 2023 Mar 1;18(3):e0280495. doi: 10.1371/journal.pone.0280495. eCollection 2023.
- Uyar A, Torrealday S, Seli E. Cumulus and granulosa cell markers of oocyte and embryo quality. Fertil Steril. 2013 Mar 15;99(4):979-97. doi: 10.1016/j.fertnstert.2013.01.129.
- Haahr T, Dosouto C, Alviggi C, Esteves SC, Humaidan P. Management Strategies for POSEIDON Groups 3 and 4. Front Endocrinol (Lausanne). 2019 Sep 11;10:614. doi: 10.3389/fendo.2019.00614. eCollection 2019.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Гормоны
- Гормоны, заменители гормонов и антагонисты гормонов
- Гормоны гормонов гипофиза
- Гормоны гипоталамуса
- Пептидные гормоны
- Нейропептиды
- Пептиды
- Аминокислоты, пептиды и белки
- Олигопептиды
- Белки нервной ткани
- Белки
- Гонадотропин-рилизинг-гормон
- Гонадотропины
- Плацентарные гормоны
- Белки беременности
- Трипторелин Памоат
- Хорионический гонадотропин
- Фоллитропин Дельта
Другие идентификационные номера исследования
- TRIGGERBEST
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .