A Randomized Prospective Trial of Dual Trigger Ovulation in Oocyte Donors
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of Subjects Having Adverse Events
研究概览
简要总结
The project is a randomized, controlled, prospective study of oocyte donors comparing the safety and efficacy of triggering ovulation using a combination of two drugs-GnRH agonist and very low dose hCG-versus triggering ovulation with a standard hCG dose alone or a standard GnRH trigger alone.
详细描述
The study population will consist of young women, age 21 to 34, presenting to our facility with the desire to donate oocytes and who meet FDA and program requirements for donation.
Participants will be randomized to one of the three treatment interventions for triggering ovulation: 1) a standard dose of hCG, 2) leuprolide acetate 2 mg alone, or 3) a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU).
Study participants who choose to repeat oocyte donation during the course of the study trial, and who consent to participate in the trial again, will be randomized in a cross-over manner for any subsequent trials.
Following randomization, the clinical care of study subjects will be the same as for non-participant oocyte donors. Participants in all three study arms will undergo standard ovarian stimulation protocol with gonadotropins, standard individualized adjustment of medication dose, standard criteria for administration of the ovulation trigger dose, and standard egg retrieval procedure.
The recipient population will be recruited from women, age 18 to 55, who present to our center wishing to become pregnant using donor oocytes. All prospective participants who meet the Center for Reproductive Medicine (CRM) criteria be recipients of donated eggs will be eligible to participate, should they wish to do so.
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
- 21 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Young women, age 21 to 34, presenting to our facility with the desire to donate oocytes and meeting FDA and program requirements for donation.
- •Women, age 21 to 55, presenting to our facility with the desire to donate oocytes and meeting FDA and program requirements to be recipients of donated eggs.
排除标准
- •Less than 2 ovaries or any other significant ovarian abnormality
- •Does not meet current FDA or program requirements for donation.
- •A contraindication for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, clinically significant ovarian cysts)
- •A contraindication for the use of oral contraceptive pills (h/o thromboembolism, breast cancer, undiagnosed vaginal bleeding)
- •Known gene defects, genetic abnormalities or abnormal karyotype
- •Contraindication or hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol
- •Inability to give informed consent
- •Donors who, because of their place of residence or personal situation, would not be able to commit to all required time points including the one extra visit required by study participation.
- •The subject has a recent history of/or current epilepsy, thrombophilia, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease
研究组 & 干预措施
hCG
standard dose of hCG for ovulation trigger
干预措施: HCG (Drug)
Lupron Trigger
Leuprolide acetate 2 mg ovulation trigger
干预措施: Lupron Trigger (Drug)
Dual Trigger
Lupron and hCG combined ovulation trigger
干预措施: Dual Trigger (Drug)
结局指标
主要结局
Number of Subjects Having Adverse Events
时间窗: 1 month
Any donor having a serious complication such as severe hyperstimulation syndrome, ovarian torsion, infection or peritoneal bleeding will be recorded
Number of Days Post Retrieval Until Subject is Able to Resume Her Usual Activities
时间窗: 7 days post retrieval
Subjects will complete a brief questionnaire on post retrieval day 7. They will state how many days after retrieval they were able to resume their usual activities.
Ovarian Volume
时间窗: 7 days post retrieval
Ovarian volume of both ovaries will be measured by ultrasound on post op day number 7. Measurements will be taken in three different dimensions and volume calculated from those measurements.
次要结局
- Number of Mature Oocytes Retrieved(1 day post ovulation)
- Pregnancies Per Transfer(4 weeks post retrieval)