Moro Francesca, Scarinci Elisa, Palla Carola, Romani Federica, Familiari Alessandra, Tropea Anna, Leoncini Emanuele, Lanzone Antonio, Apa Rosanna
Institute of Obstetrics and Gynecology, Università Cattolica del Sacro Cuore, Rome, Italy
Institute of Obstetrics and Gynecology, Università Cattolica del Sacro Cuore, Rome, Italy.
Hum Reprod. 2015 Jan;30(1):179-85. doi: 10.1093/humrep/deu302. Epub 2014 Nov 14.
Is the treatment with recombinant FSH (rFSH) plus recombinant LH (rLH) more effective than highly purified (HP)-hMG in terms of ongoing pregnancy rate (PR) in women ≥35 years of age undergoing intrauterine insemination (IUI) cycles?
The ongoing PR was not significantly different in women treated with rFSH plus rLH or with HP-hMG.
Although previous studies have shown beneficial effects of the addition of LH activity to FSH, in terms of PR in patients aged over 34 years having ovulation induction, no studies have compared two different gonadotrophin preparations containing LH activity in women ≥35 years of age in IUI cycles.
STUDY DESIGN, SIZE, DURATION: A single-centre RCT was performed between May 2012 and September 2013 with 579 women ≥35 years of age undergoing IUI cycles. The patients were randomly assigned to one of the two groups, rFSH in combination with rLH group or HP-hMG (Meropur) group, by giving them a code number from a computer generated randomization list, in order of enrolment. The randomization visit took place on the first day of ovarian stimulation.
PARTICIPANTS/MATERIALS, SETTING, METHODS: Five hundred and seventy-nine patients with unexplained infertility or mild male factor undergoing IUI cycles were recruited in a university hospital setting. All women were enrolled in this study only for one cycle of treatment. Five hundred and seventy-nine cycles were included in the final analysis. Two hundred and ninety patients were treated with rFSH in combination with rLH and 289 patients were treated with HP-hMG. The ovarian stimulation cycle started on the third day of the menstrual cycle and the starting gonadotrophin doses used were 150 IU/day of rFSH plus 150 IU/day of rLH or 150 IU/day of HP-hMG. The drug dose was adjusted according to the individual follicular response. A single IUI per cycle was performed 34-36 h after hCG injection.
The main outcome measures were ongoing PR and number of interrupted cycles for high risk of ovarian hyperstimulation syndrome (OHSS). Ongoing pregnancy rates were 48/290 (17.3%) in the recombinant group versus 35/289 (12.2%) in the HP-hMG group [(odds ratio (OR) 1.50, 95% CI 0.94-2.41, P = 0.09]. The number of interrupted cycles for high risk of OHSS was 13/290 (4.5%) in the rFSH plus rLH group and 2/289 (0.7%) in the HP-hMG group (OR 6.73, 95% CI 1.51-30.12, P = 0.013).
LIMITATIONS, REASONS FOR CAUTION: One of the limitations of this study was the early closure and the ongoing PR could be overestimated. Both patient and gynaecologist were informed of the assigned treatment.
Our results demonstrated the lack of differences in terms of ongoing PR between recombinant product and HP-hMG, in women ≥35 years undergoing controlled ovarian stimulation for IUI cycles. HP-hMG was safer than recombinant gonadotrophin concerning the risk of OHSS.
STUDY FUNDING/COMPETING INTERESTS: None.
NCT01604044.
对于年龄≥35岁接受宫腔内人工授精（IUI）周期治疗的女性，重组促卵泡激素（rFSH）联合重组促黄体生成素（rLH）治疗在持续妊娠率（PR）方面是否比高度纯化（HP）的人绝经期促性腺激素（hMG）更有效？
接受rFSH联合rLH治疗或HP-hMG治疗的女性，其持续妊娠率无显著差异。
尽管先前的研究已表明在促卵泡激素中添加促黄体生成素活性具有有益效果，但就年龄超过34岁接受促排卵治疗的患者的妊娠率而言，尚无研究比较过年龄≥35岁接受IUI周期治疗的女性使用的两种含促黄体生成素活性的不同促性腺激素制剂。
研究设计、规模、持续时间：2012年5月至2013年9月在单中心进行了一项随机对照试验（RCT），共有579名年龄≥35岁的女性接受IUI周期治疗。通过从计算机生成的随机列表中为患者分配一个代码编号，并按入组顺序将患者随机分配至两组之一，即rFSH联合rLH组或HP-hMG（Meropur）组。随机分组访视在卵巢刺激的第一天进行。
参与者/材料、环境、方法：在一所大学医院招募了579例不明原因不孕或轻度男性因素导致不孕且接受IUI周期治疗的患者。所有女性仅纳入一个治疗周期。最终分析纳入了579个周期。290例患者接受rFSH联合rLH治疗，289例患者接受HP-hMG治疗。卵巢刺激周期在月经周期的第三天开始，起始促性腺激素剂量为每天150 IU的rFSH加每天150 IU的rLH或每天150 IU的HP-hMG。药物剂量根据个体卵泡反应进行调整。每个周期在注射人绒毛膜促性腺激素（hCG）后34 - 36小时进行一次IUI。
主要观察指标为持续妊娠率和因卵巢过度刺激综合征（OHSS）高风险而中断的周期数。重组组的持续妊娠率为48/290（17.3%），而HP-hMG组为35/289（12.2%）[比值比（OR）1.50，95%置信区间（CI）0.94 - 2.41, P = 0.09]。rFSH加rLH组因OHSS高风险而中断的周期数为13/290（4.5%），HP-hMG组为2/289（0.7%）（OR 6.73，95% CI 1.51 - 30.12，P = 0.013）。
局限性、谨慎理由：本研究的局限性之一是提前结束，持续妊娠率可能被高估。患者和妇科医生均知晓所分配的治疗方案。
我们的结果表明，对于年龄≥35岁接受控制性卵巢刺激以进行IUI周期治疗的女性，重组产品与HP-hMG在持续妊娠率方面无差异。就OHSS风险而言，HP-hMG比重组促性腺激素更安全。
研究资金/利益冲突：无。
NCT01604044。
