Vuong Lan N, Ho Vu N A, Le Anh H, Nguyen Nam T, Pham Toan D, Nguyen Minh H N, Le Ho L, Le Tien K, Ha Anh N, Le Xuyen T H, Pham Huy H, Tran Cam T, Huynh Bao G, Smitz Johan E J, Gilchrist Robert B, Ho Tuong M
Department of Obstetrics and Gynecology, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam; HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam.
HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam; IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.
Fertil Steril. 2025 Feb;123(2):253-261. doi: 10.1016/j.fertnstert.2024.09.010. Epub 2024 Sep 12.
To compare oocyte maturation rates and pregnancy outcomes in women with polycystic ovary syndrome (PCOS) undergoing biphasic in vitro maturation (capacitation in vitro maturation [CAPA-IVM]) with vs. without follicle-stimulating hormone (FSH) priming.
Randomized, controlled, assessor-blinded trial.
Women aged 18-37 years with PCOS and an indication for CAPA-IVM.
INTERVENTION(S): Participants were randomized (1:1) to undergo CAPA-IVM with or without FSH priming. The FSH priming group had 2 days of FSH injections before oocyte pickup; no FSH was given in the non-FSH group. After CAPA-IVM, day-5 embryos were vitrified for transfer in a subsequent cycle.
MAIN OUTCOME MEASURE(S): The primary endpoint was number of matured oocytes. Secondary outcomes included rates of live birth, implantation, clinical pregnancy, ongoing pregnancy, pregnancy complications, obstetric and perinatal complications, and neonatal complications.
RESULT(S): The number (interquartile range) of matured oocytes did not differ significantly in the non-FSH vs. FSH group (13 [9-18] vs. 14 [7-18]; absolute difference -1 [95% confidence interval -5 to 4]); other oocyte and embryology outcomes did not differ between groups. Rates of ongoing pregnancy and live birth were 38.3% in the non-FSH group and 31.7% in the FSH group (risk ratio for both outcomes: 1.21, 95% confidence interval 0.74-1.98). Maternal complications were infrequent and occurred at a similar rate in the two groups; there were no preterm deliveries before 32 weeks gestation.
CONCLUSION(S): These findings open the possibility of a new, hormone-free approach to infertility treatment of women with PCOS.
NCT05600972.
比较多囊卵巢综合征（PCOS）女性在接受双相体外成熟（体外获能成熟[CAPA-IVM]）时，使用与不使用促卵泡激素（FSH）预处理的卵母细胞成熟率和妊娠结局。
随机、对照、评估者盲法试验。
年龄在18 - 37岁之间、患有PCOS且有CAPA-IVM指征的女性。
参与者被随机（1:1）分为接受或不接受FSH预处理的CAPA-IVM组。FSH预处理组在取卵前注射FSH 2天；非FSH组不给予FSH。CAPA-IVM后，第5天的胚胎进行玻璃化冷冻，以便在后续周期进行移植。
主要终点是成熟卵母细胞的数量。次要结局包括活产率、着床率、临床妊娠率、持续妊娠率、妊娠并发症、产科和围产期并发症以及新生儿并发症。
非FSH组与FSH组成熟卵母细胞的数量（四分位间距）无显著差异（13[9 - 18]对14[7 - 18]；绝对差异-1[95%置信区间-5至4]）；其他卵母细胞和胚胎学结局在两组之间无差异。非FSH组的持续妊娠率和活产率为38.3%，FSH组为31.7%（两种结局的风险比：1.21，95%置信区间0.74 - 1.98）。母体并发症很少见，两组发生率相似；妊娠32周前无早产。
这些发现为PCOS女性不孕症治疗开辟了一种新的、无激素方法的可能性。
NCT05600972。
