The Effect of Melatonin Supplementation on Cumulus Cells and IVF Outcomes

Официальное название

The Effect of Melatonin Supplementation on Cumulus Cells and Reproductive Outcomes in Older Women Undergoing IVF Cycles

Обзор

This study investigates the effects of melatonin supplementation on cumulus cell gene expression and in vitro fertilization (IVF) outcomes in women over 35 years old. In the study group, patients will receive melatonin supplementation for at least two months prior to their IVF cycles. Cumulus cells will be collected after oocyte retrieval, and IVF outcomes will be assessed.

Подробное описание

Aging in female reproductive cells, particularly cumulus granulosa cells, is associated with various dysfunctions that compromise fertility. Melatonin, a hormone primarily produced by the pineal gland, is renowned for its multifaceted roles in regulating physiological processes, including sleep-wake cycles, immune function, and antioxidative defense. Melatonin's antioxidant action is mediated through direct scavenging of free radicals, upregulation of antioxidant enzymes, and improvement of mitochondrial efficiency. These properties make melatonin a promising candidate for mitigating the adverse effects of aging on cellular function. This study aims to explore the effects of melatonin supplementation on cumulus cell gene expression and in vitro fertilization (IVF) outcomes in women over 35 years old. In the study group, patients will receive melatonin supplementation for at least two months prior to their IVF cycles. In the control group, patients will proceed directly to IVF cycles without melatonin supplementation. Cumulus cells will be collected after oocyte retrieval, and gene expression will be measured. Additionally, clinical pregnancy rate, live birth rate, and miscarriage rate between the two groups will be evaluated.

Вмешательства

• Пищевая добавка Melatonin
  In the study group, patients will receive melatonin supplementation for at least two months prior to IVF cycles

Первичные конечные точки

• Live birth rate (%) [Срок оценки: through study completion, an average of 4 year]
• oxygen consumption rate of mitochodria (%) [Срок оценки: through study completion, an average of 4 year]
• mRNA levels of cumulus cell genes [Срок оценки: through study completion, an average of 4 year]

Вторичные конечные точки (3)

• Clinical pregnancy rate (%) [Срок оценки: through study completion, an average of 4 year]
• Ongoing pregnancy rate (%) [Срок оценки: through study completion, an average of 4 year]
• Amount of ATP production (moles/min) of mitochodria [Срок оценки: through study completion, an average of 4 year]

Критерии участия

Критерии включения

• Age 35-45 years
• BMI 18-30 kg/m2
• planning to undergo IVF cycles

Критерии исключения

• Primary ovarian insufficiency
• history of oophorectomy
• receiving oocyte donation
• Chromosome anomaly
• Congenital uterine anomaly
• Severe intrauterine adhesion
• Malignancy
• Using hormone therapy or supplements in recent 3 months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, T — Kaohsiung City

Публикации

• Kandil OM, Rahman SMAE, Ali RS, Ismail EA, Ibrahim NM. Effect of melatonin on developmental competence, mitochondrial distribution, and intensity of fresh and vitrified/thawed in vitro matured buffalo oocytes. Reprod Biol Endocrinol. 2024 Apr 5;22(1):39. doi: 10.1186/s12958-024-01209-7. PMID 38580962
• Navid S, Saadatian Z, Talebi A. Assessment of developmental rate of mouse embryos yielded from in vitro fertilization of the oocyte with treatment of melatonin and vitamin C simultaneously. BMC Womens Health. 2023 Oct 4;23(1):525. doi: 10.1186/s12905-023-02673-w. PMID 37794412
• He C, Wang J, Zhang Z, Yang M, Li Y, Tian X, Ma T, Tao J, Zhu K, Song Y, Ji P, Liu G. Mitochondria Synthesize Melatonin to Ameliorate Its Function and Improve Mice Oocyte's Quality under in Vitro Conditions. Int J Mol Sci. 2016 Jun 14;17(6):939. doi: 10.3390/ijms17060939. PMID 27314334
• Yang M, Tao J, Chai M, Wu H, Wang J, Li G, He C, Xie L, Ji P, Dai Y, Yang L, Liu G. Melatonin Improves the Quality of Inferior Bovine Oocytes and Promoted Their Subsequent IVF Embryo Development: Mechanisms and Results. Molecules. 2017 Nov 27;22(12):2059. doi: 10.3390/molecules22122059. PMID 29186876
• Zhao XM, Wang N, Hao HS, Li CY, Zhao YH, Yan CL, Wang HY, Du WH, Wang D, Liu Y, Pang YW, Zhu HB. Melatonin improves the fertilization capacity and developmental ability of bovine oocytes by regulating cytoplasmic maturation events. J Pineal Res. 2018 Jan;64(1). doi: 10.1111/jpi.12445. Epub 2017 Oct 11. PMID 28833478
• Dai X, Lu Y, Zhang M, Miao Y, Zhou C, Cui Z, Xiong B. Melatonin improves the fertilization ability of post-ovulatory aged mouse oocytes by stabilizing ovastacin and Juno to promote sperm binding and fusion. Hum Reprod. 2017 Mar 1;32(3):598-606. doi: 10.1093/humrep/dew362. PMID 28137755
• Miao Y, Zhou C, Bai Q, Cui Z, ShiYang X, Lu Y, Zhang M, Dai X, Xiong B. The protective role of melatonin in porcine oocyte meiotic failure caused by the exposure to benzo(a)pyrene. Hum Reprod. 2018 Jan 1;33(1):116-127. doi: 10.1093/humrep/dex331. PMID 29112712
• Zhang M, Dai X, Lu Y, Miao Y, Zhou C, Cui Z, Liu H, Xiong B. Melatonin protects oocyte quality from Bisphenol A-induced deterioration in the mouse. J Pineal Res. 2017 Apr;62(3). doi: 10.1111/jpi.12396. Epub 2017 Mar 1. PMID 28178360

Идентификаторы

NCT: NCT06546774 · KSVGH21-CT1-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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