Effect of GH on the Blastocyst Euploid Rate in AMA Patients

Официальное название

A Randomized Control Trial to Investigate the Effect of Growth Hormone on the Euploid Rate of Blastocyst in Patients With Advanced Maternal Age

Обзор

This randomized trial aims to compare the euploid rate of blastocysts in AMA patients undergoing PGT-A (preimplantation genetic testing for aneuploidy) with or without growth hormone supplement. Infertile patients ≥38 years old will be recruited for study after informed consent if they fulfill the inclusion criteria and do not have the exclusion criteria. Eligible women will be randomised into one of the two groups: Treatment group: Women will receive growth hormone (GH) supplement before and during antagonist protocol for ovarian stimulation. Control group: Women will receive antagonist protocol for ovarian stimulation. The primary outcome is the euploidy rate of blastocysts.

Вмешательства

• Препарат Growth Hormone
  Growth hormone is supplemented before and during the ovarian stimulation till the day of oocyte retrieval
• Препарат GnRH antagonist
  GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger

Первичные конечные точки

• euploidy rate [Срок оценки: 1 month after oocyte retrieval]

Вторичные конечные точки (7)

• live birth rate [Срок оценки: 1 year after embryo transfer]
• cumulative live birth rate [Срок оценки: 1 year after embryo transfer]
• ongoing pregnancy [Срок оценки: 12 weeks' gestation]
• clinical pregnancy rate [Срок оценки: 6 weeks after embryo transfer]
• number of euploid blastocysts in an OS cycle [Срок оценки: 1 month after oocyte retrieval]
• the probability of obtaining euploid blastocysts in an OS cycle [Срок оценки: 1 month after oocyte retrieval]
• KIDScore of euploid embryos [Срок оценки: 6 days after oocyte retrieval]

Критерии участия

Критерии включения

• Age ≥38; intended to undergo PGT-A
• BMI in the normal range (18.50-24.0kg/m2)
• Normal semen analysis for the male partner

Критерии исключения

• Endometriosis grade 3 or higher, untreat hydrosalpinx
• Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus uni-cornate, bicornate, or duplex); untreated uterine septum, adenomyosis, submucous myoma, or endo-metrial polyp(s)
• Women who are indicated and planned to undergo PGT-SR (Preimplantation genetic testing for structural rearrangement) or PGT-M (Preimplantation genetic testing for monogenic disorder), for example, parental abnormal karyo-type or diagnosed with monogenic disease
• History of endocrine disorder, autoimmune diseases or diagnosed thrombophilia
• History of GH supplementation in the previous IVF treatment or taking other supplementary drugs used during stimulation; patients with absolute or relative contraindications to GH treatment, including active malignancy or history of cancer, diabetic retinopathy, diabetes mellitus, and chronic kidney disease.

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

Китай · 1 центр

• Shanghai JIAI Genetics and IVF Institute — Шанхай

Публикации

• Demko ZP, Simon AL, McCoy RC, Petrov DA, Rabinowitz M. Effects of maternal age on euploidy rates in a large cohort of embryos analyzed with 24-chromosome single-nucleotide polymorphism-based preimplantation genetic screening. Fertil Steril. 2016 May;105(5):1307-1313. doi: 10.1016/j.fertnstert.2016.01.025. Epub 2016 Feb 8. PMID 26868992
• Weall BM, Al-Samerria S, Conceicao J, Yovich JL, Almahbobi G. A direct action for GH in improvement of oocyte quality in poor-responder patients. Reproduction. 2015 Feb;149(2):147-54. doi: 10.1530/REP-14-0494. Epub 2014 Nov 5. PMID 25376626
• Gong Y, Luo S, Fan P, Jin S, Zhu H, Deng T, Quan Y, Huang W. Growth hormone alleviates oxidative stress and improves oocyte quality in Chinese women with polycystic ovary syndrome: a randomized controlled trial. Sci Rep. 2020 Oct 30;10(1):18769. doi: 10.1038/s41598-020-75107-4. PMID 33127971
• Liu C, Li S, Li Y, Tian J, Sun X, Song T, Yan G, Ding L, Sun H. Growth hormone ameliorates the age-associated depletion of ovarian reserve and decline of oocyte quality via inhibiting the activation of Fos and Jun signaling. Aging (Albany NY). 2021 Feb 17;13(5):6765-6781. doi: 10.18632/aging.202534. Epub 2021 Feb 17. PMID 33621201
• Skillern A, Leonard W, Pike J, Mak W. Growth hormone supplementation during ovarian stimulation improves oocyte and embryo outcomes in IVF/PGT-A cycles of women who are not poor responders. J Assist Reprod Genet. 2021 May;38(5):1055-1060. doi: 10.1007/s10815-021-02088-2. Epub 2021 Feb 3. PMID 33534048
• Regan SLP, Knight PG, Yovich JL, Arfuso F, Dharmarajan A. Growth hormone during in vitro fertilization in older women modulates the density of receptors in granulosa cells, with improved pregnancy outcomes. Fertil Steril. 2018 Dec;110(7):1298-1310. doi: 10.1016/j.fertnstert.2018.08.018. PMID 30503129
• Sui Y, Zou Y, Xiao M, Fu J, Li L, Sun X. The effect of growth hormone on the euploid rate of blastocysts in patients with advanced maternal age: study protocol for a single-blinded randomized controlled trial. BMC Pregnancy Childbirth. 2026 Feb 25;26(1):359. doi: 10.1186/s12884-026-08853-4. PMID 41735936

Идентификаторы

NCT: NCT05447208 · 2022JIAI-10

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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