Department of Obstetrics and Gynecology, Family Health Research Institute, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
Vali-e-Asr Reproductive Health Research Center, Family Health Research Institute, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
BMC Womens Health. 2024 Sep 2;24(1):481. doi: 10.1186/s12905-024-03337-z.
The optimal approach to luteal-phase support in infertility treatment remains a subject of debate. This study was conducted to investigate the clinical outcomes, side effects, and patient satisfaction associated with vaginal, subcutaneous, and intramuscular progesterone administration in infertile women undergoing Frozen Embryo Transfer (FET).
This three-armed randomized clinical trial assigned infertile patients eligible for FET to three progesterone treatment groups: vaginal suppositories (400 mg twice daily; n = 100), subcutaneous injections (25 mg daily; n = 102), and intramuscular injections (50 mg daily; n = 108). The primary outcomes were chemical and clinical pregnancy rates per embryo transfer cycle, with chemical pregnancy defined as beta-human chorionic gonadotropin levels > 50 IU/mL two weeks post-transfer and clinical pregnancy confirmed by ultrasound four weeks later. Exploratory outcomes included progesterone-related adverse effects and participant satisfaction, assessed via a Likert-scale survey 12 weeks post-transfer. Statistical analyses included Chi-square tests for categorical data, one-way analysis of variances, and Kruskal-Wallis tests for continuous data.
The intramuscular progesterone group had significantly higher chemical pregnancy rates compared to the vaginal and subcutaneous groups (41.7% vs. 26.0% and 27.5%, respectively; p = 0.026). Although the clinical pregnancy rate was also higher in the intramuscular group (32.4%) compared to the vaginal (23.0%) and subcutaneous groups (21.6%), this difference was not statistically significant (p = 0.148). Additionally, patient satisfaction was greater with vaginal and subcutaneous applications than with intramuscular injections (p < 0.001), likely due to a significantly higher incidence of side effects, such as pain and edema at the injection site, in the intramuscular group (p < 0.001).
We found that intramuscular progesterone resulted in higher chemical pregnancy rates than vaginal or subcutaneous routes, but this did not translate into higher clinical pregnancy rates. Despite its effectiveness, intramuscular administration was associated with more adverse effects and lower patient satisfaction. Future research should explore optimizing progesterone regimens to balance efficacy and patient comfort.
The trial protocol was registered on December 6, 2020, in the Iranian Registry of Clinical Trials (IRCT), a primary registry in the World Health Organization (WHO) Registry Network, under the registration number IRCT20141217020351N12.
黄体支持在不孕治疗中的最佳方法仍存在争议。本研究旨在探讨接受冻融胚胎移植（FET）的不孕妇女使用阴道、皮下和肌肉内给予孕激素的临床结局、副作用和患者满意度。
这是一项三臂随机临床试验，将适合 FET 的不孕患者分为三组孕激素治疗组：阴道栓剂（400mg，每日 2 次；n=100）、皮下注射（25mg，每日 1 次；n=102）和肌肉内注射（50mg，每日 1 次；n=108）。主要结局是每个胚胎移植周期的化学妊娠和临床妊娠率，化学妊娠定义为β-人绒毛膜促性腺激素水平在移植后两周>50IU/mL，四周后通过超声确认临床妊娠。探索性结局包括孕激素相关不良反应和患者满意度，通过移植后 12 周的李克特量表调查评估。统计分析包括卡方检验用于分类数据，单因素方差分析和 Kruskal-Wallis 检验用于连续数据。
肌肉内孕激素组的化学妊娠率明显高于阴道组和皮下组（分别为 41.7%、26.0%和 27.5%；p=0.026）。尽管肌肉内组的临床妊娠率也高于阴道组（23.0%）和皮下组（21.6%），但差异无统计学意义（p=0.148）。此外，阴道和皮下应用的患者满意度高于肌肉内注射（p<0.001），可能是由于肌肉内组不良反应发生率更高，如注射部位疼痛和肿胀（p<0.001）。
我们发现肌肉内孕激素导致的化学妊娠率高于阴道或皮下途径，但这并未转化为更高的临床妊娠率。尽管肌肉内给药有效，但与更多的不良反应和较低的患者满意度相关。未来的研究应探索优化孕激素方案，以平衡疗效和患者舒适度。
试验方案于 2020 年 12 月 6 日在世界卫生组织（WHO）注册网络的伊朗临床试验注册中心（IRCT）注册，注册号为 IRCT20141217020351N12。
