Comparison of Tamoxifen and Clomiphene Citrate in Mild Stimulation IVF: a Prospective Cohort Study
试验速览
- 阶段
- 4 期
- 入组人数
- 210
- 主要终点
- clinical pregnancy rate
研究概览
简要总结
The purpose of this prospective cohort study is to compare IVF outcome between tamoxifen and clomiphene citrate in mild stimulation.
详细描述
The reported prevalence of poor ovarian responders amongst patients undergoing IVF-ET is 9%-24%, and morbidity must be higher nowadays. For these women, Mild stimulation has been an important ovulation induction protocol. Clomiphene citrate(CC) and tamoxifen(TMX) are commonly used in mild stimulation protocol. It's reported that CC has adverse effect on growth of endrometrium and results in thin endrometrium(≤7mm) which maybe affect pregnancy rate. However, TMX has estrogen-like effect on the endrometrium that may be helpful to increase endormetrial thickness. The reported results about comparing CC with TMX showed that they had similar ovulation rate. Prospective study is necessary to confirm whether TMX is superior to CC on the IVF outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 37 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age between 37 and 42;
- •BMI≤23kg/m2;
- •≤3 oocytes with a conventional stimulation protocol;
- •AFC<5 follicles or AMH<1.1 ng/ml on the day 1 to 5 of the menses;
- •Cause of Infertiity: tubal factor, male factor, diminished ovarian reserve.
排除标准
- •endormetrial polyp, endormetrial cancer,intrauterine adhesions,uterine fibroids that affects uterine cavity
- •Endometriosis, adenomyosis
- •The diameter of Hydrosalpinx >2cm
研究组 & 干预措施
clomiphene
All patients will have serum hormone examination and be monitored by transvaginal ultrasound for ovaries on the day 3 of the menses（D3）.Patients in clomiphene group will take 100 mg of CC oral tablets daily from D3 for 5 days.All patients will have sexual hormone determination and be monitored by transvaginal ultrasound for the mean follicular diameter and endometrial thickness on the day 8 of the cycle.The investigators will add HMG and GnRH-ant according to follicular diameter,E2 and LH. Human chorionic gonadotropin(hCG) (5000-10000 IU IM) will be given when one follicle measured at least 18 mm is found. IVF or ICSI will be performed 34-36 h after hCG injection. All patients will receive luteal phase support with progesterone 60 mg im qd for 2 weeks.
干预措施: Clomiphene (Drug)
tamoxifen
All patients will have serum hormone examination and be monitored by transvaginal ultrasound for ovaries on the day 3 of the menses（D3）.Patients in the tamoxifen group will take 20 mg of tamoxifen oral tablets daily from D3 for 5 days.All patients will check serum E2 and be monitored by transvaginal ultrasound for the mean follicular diameter and endometrial thickness on the day 8 of the cycle. The investigators will add HMG and GnRH-ant according to follicular diameter,E2 and LH. Human chorionic gonadotropin(hCG) (5000-10000 IU IM) will be given when one follicle measured at least 18 mm is found. IVF or ICSI will be performed 34-36 h after hCG administration. All patients will receive luteal phase support with progesterone 60 mg im qd for 2 weeks.
干预措施: Tamoxifen (Drug)
结局指标
主要结局
clinical pregnancy rate
时间窗: four weeks after embryo transfer
次要结局
- endrometrial pattern and thickness on the day of HCG administration(on the HCG day)
- cycle cancellations for thin endrometrial thickness(on the HCG day)
- the number of follicular diameter≥10mm and sexual hormone test on the HCG day(on the HCG day)
研究者
Haiyan Lin
attending doctor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University