Dydrogesterone use in early pregnancy

Abstract

Successful oocyte implantation and a favorable pregnancy outcome rely on optimal progesterone levels. Therefore, progesterone deficiencies associated with infertility and miscarriage have commonly been treated with progestogens that mimic the activity of progesterone. Among those is dydrogesterone, an oral retrosteroid with a structure closely related to that of progesterone yet with a greater bioavailability and higher selectivity for the progesterone receptor. This review describes the efficacy of dydrogesterone for the treatment of threatened and recurrent miscarriage, and infertility due to luteal phase insufficiency. Data from clinical trials evaluating dydrogesterone in assisted reproductive technology are also discussed. Prospective clinical trials, systematic reviews and meta-analyses have demonstrated that dydrogesterone significantly improves pregnancy outcomes in women with threatened miscarriage or with a history of miscarriage. Although this is not yet a registered indication, dydrogesterone was as effective as vaginal micronized progesterone for luteal phase support in the setting of assisted reproductive technology. The safety and tolerability of dydrogesterone treatment in pregnant women are also briefly addressed and the data support a well-established and favorable benefit–risk profile.

Chinese abstract

成功的卵母细胞植入和良好的妊娠结局有赖于理想的孕激素水平。因此，与不孕和流产相关的孕激素缺乏常使用模拟孕酮活性的孕激素进行治疗。其中地屈孕酮是一种口服的逆转的甾体激素，其结构与孕酮密切相关，而具有更好的生物利用度及更高的孕激素受体选择性。这篇综述描述了地屈孕酮治疗因黄体功能不全所致的先兆流产、复发性流产及不孕的有效性，还对评估辅助生殖技术中地屈孕酮运用的临床试验数据进行了讨论。前瞻性临床试验、系统性评价及Meta分析已经证实：地屈孕酮明显改善先兆流产或有流产史女性的妊娠结局。尽管这是一个尚未注册的指征，地屈孕酮在辅助生殖技术中对黄体的支持和阴道微粉化黄体酮同样有效。文章还对地屈孕酮治疗孕妇的安全性和耐受性进行了简要介绍，资料支持其已确立良好的效益-风险问题。

• Assisted reproductive technology
• dydrogesterone
• luteal phase support
• pregnancy
• progestogen
• threatened or recurrent miscarriage

Declaration of interest

The authors would like to thank Dr Camille Bonomelli of Alpharmaxim Healthcare Communications for medical writing support, which was funded by Abbott Healthcare Products.

Fadi Mirza has fulfilled speaker engagements with Abbott. He has not received any form of compensation in return for his efforts in the writing of the manuscript.

Ameet Patki has been part of the Global Advisory Board for Duphaston® (dydrogesterone) since 2010. He has not received any form of compensation in return for his efforts in the writing of the manuscript.

Claire Pexman-Fieth is an employee of Abbott and owns shares of Abbott.