Pilot Trial to Investigate a Higher Dose of Rekovelle in Oocyte Donors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assest the dose of 15µg of follitropin delta aimed at obtaining 17 oocytes (considering the optimal range of oocytes from 15 to 25).
研究概览
简要总结
Higher numbers of oocytes have not been shown to increase implantation or live newborn rates, but higher numbers of oocytes are likely to be beneficial in certain treatments. These clinical cases where a high ovarian response can be IVF cycles with genetic diagnosis, patients who need more than one pregnancy or, as in our case, oocyte donation. For this reason, and based on previous studies, investigators intend to increase the ovarian response by increasing the dose of follitropin. This clinical trial aims to evaluate high doses of Rekovelle (follitropin delta) to obtain an average of 17 oocytes in a population of oocyte donors, without affecting the health of the patients.
详细描述
IVF ovarian stimulation cycles has been shown that the individualization of the medication doses provides clinical results comparable to conventional ovarian stimulation regimens, but also it results in greater treatment safety by significantly reducing the percentage of patients with responses extreme ovaries, and cycle cancellations. These studies have been carried out with the premise that an optimal ovarian response results in obtaining 8-14 oocytes per puncture. Although it has also been shown that larger numbers of oocytes do not increase clinical variables such as implantation rates or live newborn per cycle, it is possible that these numbers of oocytes are insufficient in specific circumstances, for example, patients with a desire to have more pregnancy, patients undergoing IVF cycles with PGT-A, or gamete donors. For these reasons, and thanks to the improvements in cryopreservation programs and the induction of oocyte maturation with GnRH agonists, it is necessary to design protocols for the individualization of doses of medication aimed at obtaining greater quantities of oocytes. The objective of this pilot study is the evaluation of higher doses of Rekovelle (follitropin delta) aimed at obtaining 17 oocytes in voluntary donors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
OOCYTE DONORS
Administration of a higher dose of Rekovelle (follitropin delta) to increase the ovarian response to 17 oocytes (the optimal range being 15 to 25 oocytes) in an oocyte donor population without compromising safety and efficacy.
干预措施: Follitropin Delta, Recombinant (Drug)
结局指标
主要结局
Assest the dose of 15µg of follitropin delta aimed at obtaining 17 oocytes (considering the optimal range of oocytes from 15 to 25).
时间窗: Number of oocytes obtained inmediatly after the ovarian puncture in visit 5
To evaluate the number of oocytes of a fixed dose of 15µg of the drug Rekovelle (follitropin delta) during the entire stimulation of oocyte donors aimed at obtaining 17 oocytes (considering the optimal range of oocytes from 15 to 25).
Measure the incidence of ovarian hyperstimulation syndrome using15µg of follitropin delta aimed at obtaining 17 oocytes
时间窗: Through the study completion, an average 1 month.
Evaluate with a GOLAN scale. Golan classification: Classify early or late ovarian hyperstimulation syndrome, according to clinic, ultrasound and laboratory tests Mild ovarian hyperstimulation: * Grade 1 Abdominal discomfort and bloating * Grade 2 Grade 1 + nausea, vomiting, or diarrhea. Ovaries enlarged 5-12 cm in ø Moderate Hyperstimulation: • Grade 3 Grade 2 + ultrasound signs of ascites Severe hyperstimulation: * Grade 4 Grade 3 + clinical ascites, respiratory distress, hydrothorax * Grade 5 Grade 4 and hemoconcentration, hypovolemia, impaired coagulation and renal function (oligo / anuria)
次要结局
- Duration of stimulation in days(Number of days during the ovarian stimulation up to 20 days)
- Blast quality(4-6 days after fertilization and before implantation in the endometrium during the treatment.)
- Degree of satisfaction with the infertility treatment(At the end of the treatment, an average 1 month.)
- Number of mature oocytes(Number of madure oocytes obtained inmediatly after the puncture in visit 5)
- Number of blasts(4-6 days after fertilization and before implantation in the endometrium during the treatment.)