Obstetrics and Gynecology Department, Faculty of Medicine, Minia University, Minia, Egypt.
Reproductive Health Research Department, National Research Centre, 33 El-Buhouth St, Dokki, Cairo, 12622, Egypt.
BMC Pregnancy Childbirth. 2021 Mar 30;21(1):264. doi: 10.1186/s12884-021-03736-2.
Endometriosis affects the responsiveness to ovarian stimulation. This study aimed to assess the role of Dienogest pretreatment for endometriosis suppression as compared to Gonadotropin-releasing hormone agonist (GnRHa) in patients with endometriosis pursuing IVF treatment.
In this randomized controlled trial, 134 women with endometriosis-related infertility were randomly allocated to group A (n = 67) who had monthly depot GnRHa for 3 months before ovarian stimulation in IVF treatment (Ultra-long protocol), and Group B (n = 67) who had daily oral Dienogest 2 mg/d for 3 months before starting standard long protocol for IVF. The primary outcome measure was the number of oocytes retrieved. The secondary outcome measures included the number of mature oocytes, fertilization rate, quality of life assessed by FertiQoL scores, cost of treatment, and pregnancy outcomes.
Although there was no statistically significant difference between both groups regarding ovarian stimulation, response parameters, and pregnancy outcomes, the Dienogest group had a lower cost of treatment (2773 vs. 3664 EGP, P < 0.001), lower side effects (29.9% vs. 59.7%, P < 0.001), higher FertiQoL treatment scores (33.2 vs. 25.1, P < 0.001) and higher tolerability scores (14.1 vs. 9.4, P < 0.001 < 0.001).
Our study indicates that Dienogest is a suitable and safe substitute for GnRHa pretreatment in endometriosis patients.
NCT04500743 "Retrospectively registered on August 5, 2020".
子宫内膜异位症影响对卵巢刺激的反应。本研究旨在评估地诺孕素预处理抑制子宫内膜异位症与促性腺激素释放激素激动剂（GnRHa）在接受体外受精（IVF）治疗的子宫内膜异位症患者中的作用。
在这项随机对照试验中，134 名患有与子宫内膜异位症相关不孕的女性被随机分配到 A 组（n=67），他们在 IVF 治疗中的卵巢刺激前每月接受 depot GnRHa 3 个月（超长方案），和 B 组（n=67），他们在开始 IVF 的标准长方案前每天口服地诺孕素 2mg/d3 个月。主要结局测量指标是获得的卵母细胞数量。次要结局测量指标包括成熟卵母细胞数量、受精率、生活质量评估（FertiQoL 评分）、治疗费用和妊娠结局。
尽管两组在卵巢刺激、反应参数和妊娠结局方面没有统计学上的显著差异，但地诺孕素组的治疗费用较低（2773 比 3664 埃镑，P<0.001），副作用较低（29.9%比 59.7%，P<0.001），FertiQoL 治疗评分较高（33.2 比 25.1，P<0.001），耐受性评分较高（14.1 比 9.4，P<0.001）。
我们的研究表明，地诺孕素是子宫内膜异位症患者 GnRHa 预处理的一种合适且安全的替代品。
NCT04500743 “2020 年 8 月 5 日回顾性注册”。
