A prospective study of oral estrogen versus transdermal estrogen (gel) for hormone replacement frozen embryo transfer cycles

Abstract

Aim

This study was done to compare the efficacy of transdermal estrogen (gel) to oral estradiol in hormone replacement frozen embryo transfer cycles (HR- FET).

Materials and methods

This was a prospective study conducted between March 2019 and December 2019. We included 294 HR FET cycles: 156 cycles using oral estrogen tablets (oral group) and 138 cycles using transdermal gel (17 beta estradiol 0.06% w/w) (gel group). Primary objective of this study was to compare endometrial thickness (ET) on the day of progesterone start between the two groups. Our secondary objective was to compare implantation rates (IR), clinical pregnancy rates (CPR), miscarriage rates (MR), duration of estrogen administration, estradiol (E2) levels before the start of progesterone, cycle cancellation rates, patient satisfaction score and undesirable side effects between both the groups.

Results

There was no significant difference in the ET, IR, CPR, MR and duration of E2 administration and cycle cancellation rates between both the groups. Patient satisfaction score was significantly higher (8.02 ± 1.07 vs 6.96 ± 0.99 p < .01) and side effects were significantly lower (18.1% vs 55.1%, p≤.01), in the gel group compared to the oral group.

Conclusion

This study concluded that transdermal estrogen (gel) is equally efficacious as oral estrogen in HR FET cycles with transdermal gel having an added benefit of better patient comfort with less side effects and better safety profile.

摘要

目的：本研究比较经皮雌激素（Gel）和口服雌二醇在激素替代冷冻胚胎移植周期（HR-FET）中的作用。

材料与方法：这是一项在2019年3月至2019年12月期间进行的前瞻性研究。包括294个HR-FET周期：口服雌激素片156个周期（口服组）和采用透皮凝胶（17β雌二醇0.06% w/w）138个周期（凝胶组）。本研究的主要目的是比较两组孕酮开始日的子宫内膜厚度（ET）。我们的次要目标是比较两组间的植入率（IR）、临床妊娠率（CPR）、流产率（MR）、雌激素采用时间、孕酮开始前的雌二醇（E2）水平、周期取消率、患者满意度评分和不良反应。

结果：两组ET、IR、CPR、MR、E2用药时间和周期取消率均无显著性差异（P>0.05）。凝胶组患者满意度评分显著高于口服组（8.02±1.07 vs 6.96±0.99, p<0.01）, 不良反应评分明显低于口服组（18.1% vs 55.1%, p≤0.01）。

结论：结论是在HR-FET周期中, 经皮雌激素（Gel）与口服雌激素具有同等的疗效, 而且具有更好的患者舒适性, 副作用更少, 安全性更好。

Keywords:

• Oral estradiol
• transdermal estrogen (gel)
• frozen embryo transfer cycles
• endometrial thickness
• cycle outcomes

Acknowledgements

We would like to thank all the consultants, nurses and fellow doctors who helped in conducting this study. We would also like to thank Intas pharmaceuticals Ltd for providing the free drug samples used in this study.

Disclosure statement

The authors report no conflicts of interest.