Assessment and Prevention of Pain During Ovarian Stimulation in Patients With Endometriosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Average Delta in Endometriosis Pain Score Pre and Post Stimulation With and Without Use Of Letrozole
研究概览
简要总结
Randomized double blinded placebo-controlled trial to evaluate the impact of ovarian hyperstimulation on endometriosis-related symptoms and to evaluate the impact of letrozole use during ovarian hyperstimulation with respect to endometriosis-related symptoms, embryo/egg quality and quantity, and pregnancy rates.
详细描述
Randomized double blinded placebo-controlled trial to evaluate: (1) the impact of letrozole use during ovarian hyperstimulation with respect to endometriosis-related symptoms, embryo/egg quality and quantity, and pregnancy rates, (2) the impact of ovarian hyperstimulation on endometriosis-related symptoms.
There will be a total of 60 participants, 20 participants with endometriosis randomized to the placebo group, 20 participants with endometriosis randomized to the letrozole group and 20 control patients with no history of endometriosis. Letrozole and placebo medication will be started on the first day of gonadotropin injections and continued until the day of trigger shot. Medication will be restarted the night of egg retrieval and continued for 2 weeks post retrieval. Endometriosis associated symptoms will be evaluated using a survey modeled after the clinical survey developed by the World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonisation Project. Surveys will be administered at baseline ultrasound appointment for controlled ovarian hyperstimulation cycle, the day of trigger shot, 3 weeks following egg retrieval, 6 weeks following egg retrieval and 12 weeks following egg retrieval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-42 years
- •Planning to undergo controlled ovarian hyperstimulation
- •Prior diagnosis of endometriosis by one of the following: (1) surgical diagnosis (2) endometrioma on pelvic ultrasound
- •Planning to freeze all retrieved oocytes/embryos prior to transfer
排除标准
- •Hypersensitivity to letrozole
- •Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow-up, or interpretation of study results
研究组 & 干预措施
Endometriosis Placebo
Participants will be asked to take one tablet placebo daily throughout their ovarian stimulation and for 2 weeks following retrieval. Participants will be blinded to their randomization to placebo. Participants will be asked to complete surveys during their stimulation and up to 12 weeks following retrieval to evaluate endometriosis associated symptoms. Specifically, surveys will be administered at baseline ultrasound appointment for controlled ovarian hyperstimulation cycle, the day of trigger shot, 3 weeks following egg retrieval, 6 weeks following egg retrieval and 12 weeks following egg retrieval. There will be a total of 20 participants in this arm.
干预措施: Placebo oral tablet (Drug)
No Endometriosis Control
Participants will be asked to complete surveys during their ovarian stimulation and up to 12 weeks following retrieval to evaluate symptoms of pelvic pain. Specifically, surveys will be administered at baseline ultrasound appointment for controlled ovarian hyperstimulation cycle, the day of trigger shot, 3 weeks following egg retrieval, 6 weeks following egg retrieval and 12 weeks following egg retrieval. There will be a total of 20 participants in this arm.
Endometriosis Letrozole
Participants will be asked to take 5mg letrozole daily throughout their ovarian stimulation and for 2 weeks following retrieval. Participants will be blinded to their randomization to letrozole. Participants will be asked to complete surveys during their stimulation and up to 12 weeks following retrieval to evaluate endometriosis associated symptoms. Specifically, surveys will be administered at baseline ultrasound appointment for controlled ovarian hyperstimulation cycle, the day of trigger shot, 3 weeks following egg retrieval, 6 weeks following egg retrieval and 12 weeks following egg retrieval. There will be a total of 20 participants in this arm.
干预措施: Letrozole (Drug)
结局指标
主要结局
Average Delta in Endometriosis Pain Score Pre and Post Stimulation With and Without Use Of Letrozole
时间窗: Baseline ultrasound (day 2 of menstrual cycle) and day 12 (average day of trigger shot).
To evaluate how letrozole impacts pain scores throughout controlled ovarian hyperstimulation in patients with endometriosis. Pain scores will be evaluated using a 0-10 visual acuity scale, where 0 is no pain and 10 is the worst imaginable pain. The average delta between pre-stimulation pain score and day of trigger shot pain score will be compared between patients with endometriosis receiving placebo and with endometriosis receiving letrozole.
次要结局
- Follicular Fluid(Baseline ultrasound (day 2 of menstrual cycle) and day 14 (average day of egg retrieval).)
- Pregnancy Outcomes(Up to 2 years.)
- Does Letrozole Impact Embryo and Egg Quantity in Endometriosis(Baseline ultrasound (day 2 of menstrual cycle) and day 14 (average day of egg retrieval).)
- Egg Maturity(Baseline ultrasound to time of cryopreservation of eggs/embryos, which occurs within 7 days of retrieval..)
- Average Delta in Endometriosis Pain Score Pre and Post Stimulation Compared to No Endometriosis(Baseline ultrasound (day 2 of menstrual cycle) and day 12 (average day of trigger shot).)
- Trend in Endometriosis Pain Score Pre and Post Stimulation With Use Of Letrozole(Pre-stimulation through 12 weeks post retrieval)
- Average Delta in Endometriosis Pain Score Pre and Post Stimulation of Patients Receiving Placebo Compared to No Endometriosis(Baseline ultrasound (day 2 of menstrual cycle) and day 12 (average day of trigger shot).)
- Comparative Trends in Endometriosis Pain Score Pre and Post Stimulation of Patients With Endometriosis Receiving Either Placebo or Letrozole and Patients Without Endometriosis(Pre-stimulation through 12 weeks post retrieval. This time span varies per each patient's course of treatment but is typically 14 weeks in tota)
- Does Letrozole Impact Egg Quantity in Endometriosis Patients(Baseline ultrasound (day 2 of menstrual cycle) and day 14 (average day of egg retrieval).)
- Embryo Grade(2 weeks)