Research question

Does 3-months of gonadotrophin releasing hormone agonist (GnRHa) treatment before IVF improve clinical pregnancy rate in infertile patients with endometriosis?

Design

Single-blind, placebo-controlled clinical trial of 200 infertile women with endometriosis assigned to use GnRHa (study group) or placebo (control group) for 3 months before IVF. Clinical, embryological outcomes and stimulation parameters were analysed. Clinical pregnancy rate was the primary endpoint. In a subgroup of 40 patients, follicular fluid levels of oestradiol, testosterone and androstendione were measured. Gene expression profile of CYP19A1 was analysed in cumulus and mural granulosa cells.

Results

Implantation or clinical pregnancy rate were not significantly different between the two groups. Clinical pregnancy rates were 25.3% and 33.7% in the study and control groups, respectively (P = 0.212). Cumulative live birth rate was not significantly different: 22.0% (95% CI 13.0 to 31.0) in the study group and 33.7% (95% CI 24.0 to 44.0) in the control group (P = 0.077). Ovarian stimulation was significantly longer and total dose of gonadotrophins significantly higher in the study group (both P < 0.001). Serum oestradiol levels on the day of HCG were significantly lower in the study group (P = 0.001). Cancellation rate was significantly higher in the study group (P = 0.042), whereas cleavage embryos were significantly more numerous in the control group (P = 0.023). No significant differences in the expression of CYP19A1 gene in mural or cumulus granulosa cells or steroid levels in follicular fluid between the two groups were observed, but testosterone was significantly lower in the study group (P < 0.001).

Conclusion

Three-months of GnRHa treatment before IVF does not improve clinical pregnancy rate in women with endometriosis.

中文翻译：

---

试管婴儿前 GnRH 激动剂对不孕子宫内膜异位症患者结局的影响：一项随机对照试验。

研究问题

IVF前3个月的促性腺激素释放激素激动剂（GnRHa）治疗能否提高子宫内膜异位症不孕患者的临床妊娠率？

设计

对 200 名患有子宫内膜异位症的不孕女性进行的单盲、安慰剂对照临床试验，他们在 IVF 前被分配使用 GnRHa（研究组）或安慰剂（对照组）3 个月。分析了临床、胚胎学结果和刺激参数。临床妊娠率是主要终点。在 40 名患者的亚组中，测量了卵泡液中雌二醇、睾酮和雄烯二酮的水平。在卵丘和壁颗粒细胞中分析了CYP19A1 的基因表达谱。

结果

两组的着床率或临床妊娠率无显着差异。研究组和对照组的临床妊娠率分别为 25.3% 和 33.7%（P  = 0.212）。累积活产率无显着差异：研究组为 22.0%（95% CI 13.0 至 31.0），对照组为 33.7%（95% CI 24.0 至 44.0）（P  = 0.077）。研究组的卵巢刺激显着更长，促性腺激素的总剂量显着更高（均P < 0.001）。研究组的 HCG 当天血清雌二醇水平显着降低（P  = 0.001）。研究组的取消率显着较高（P = 0.042），而对照组中的卵裂胚胎明显更多（P  = 0.023）。两组间壁细胞或卵丘颗粒细胞CYP19A1基因表达或卵泡液中类固醇水平无显着差异，但研究组睾酮显着降低（P < 0.001）。

结论

IVF 前三个月的 GnRHa 治疗不会提高子宫内膜异位症女性的临床妊娠率。