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临床试验/NCT01577199
NCT01577199撤回4 期

Randomized Prospective Controlled Non-inferiority Trial of Low-dose Clomiphene Based Antagonist Protocol vs. High Dose Gonadotropin/Antagonist Protocol for IVF Poor Responders

Weill Medical College of Cornell University0 个研究点开始时间: 2012年4月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
撤回
主要终点
The number of mature oocytes retrieved

研究概览

简要总结

The purpose of this study is compare two commonly-used medication protocols ( low-dose clomiphene citrate and high dose gonadotropin protocols) for the treatment of patients with diminished ovarian reserve (decreased number of eggs remaining in the ovary) undergoing IVF. This research is being done because we do not know if these two medication protocols are equally likely to help a woman become pregnant.

详细描述

The objective of this protocol is to prospectively evaluate whether a clomid-based, low dose gonadotropin protocol (225 IU) would be non-inferior in terms of mature oocyte yield (eggs that are ready to be fertilized) as compared to a high-dose protocol.

Patients meeting the criteria for poor ovarian response will be consented and randomized to either a stimulation protocol involving pretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge (the hormone released by the brain to cause ovulation to occur, which is detectable in urine) followed by oral clomiphene citrate 100mg on days 2-6 of the menstrual cycle and 225 international units of gonadotropins starting on day 5, or to the control group involving the same pretreatment with 0.1mg luteal estradiol patches starting 10 days after the LH surge, with high dose gonadotropins (600IU) alone, starting on day 2 of the cycle. After randomization, patients will undergo routine IVF procedures, monitoring, blood draws, cancellation criteria, oocyte retrieval, and embryo transfer as non-study participants.

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
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients age 18-42 undergoing IVF
  • AFC <7 (see definition above) and AMH (see definition above) <0.5 and/or prior poor IVF response

排除标准

  • BMI (body mass index) >30
  • PGD (preimplantation genetic diagnosis, in which embryos are biopsied to rule out chromosomal abnormalities)
  • Fragile X carriers (a condition associated with premature ovarian aging)
  • TESE (Testicular sperm extraction)
  • Asherman's syndrome (uterine scarring which can affect implantation and pregnancy)
  • Untreated hydrosalpinx (accumulated fluid in the fallopian tube which may be toxic to embryos)
  • >6 prior attempted cycles

研究组 & 干预措施

High dose gonadotropins

Active Comparator

High dose gonadotropins protocol compared to Low-dose Clomiphene

干预措施: High dose gonadotropins (Drug)

Low-dose Clomiphene

Experimental

clomid-based, low dose gonadotropin protocol compared to High dose gonadotropins

干预措施: Low-dose Clomiphene (Drug)

结局指标

主要结局

The number of mature oocytes retrieved

时间窗: 1 year

To evaluate the number of mature oocytes retrieved in two different IVF protocols for poor responders

次要结局

  • The number of embryos transferred(1year)

研究者

申办方类型
Other
责任方
Sponsor

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