Follicular or Luteal Start Ovarian Stimulation With Corifollitropin Alfa. A Prospective Equivalence Study With Repeated Ovarian Stimulation in Oocyte Donors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Mean number of euploid embryos
研究概览
简要总结
To evaluate the effect of random-start of ovarian stimulation initiated in the early follicular or luteal phase on the pharmacokinetics and follicular dynamics and embryo euploidy rates in oocyte donors treated with identical ovarian stimulation protocols with corifollitropin alfa and GnRH antagonist pituitary downregulation
详细描述
The scope of the current prospective trial is to investigate whether Luteal Stimulation (LS) results in equivalent euploid embryos with Follicular Stimulation (FS) in young reproductive age women. The use of the "oocyte donor model" allows extrapolation of the results and application of LS routinely not only in healthy women undergoing fertility preservation but also in all patients irrespective of the menstrual date. This may indeed allow widespread introduction of LS in IVF programs which may result in proper scheduling of ovarian stimulation which is a major issue in everyday clinical practice.
Given that the pharmacokinetics and follicular dynamics of 150μg corifollitropin alfa for luteal stimulation has never been evaluated, the current study of luteal stimulation with corifollitropin alfa could be very interesting for several reasons:
- Potentially immediate synchronization of oocyte donors with recipients aiming to fresh oocyte donation.
- Fertility preservation patients for medical, oncological and non-medical indication
- Any situation in which endometrial receptivity is not pursued.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Healthy eligible oocyte donors
- •Age 18-34 years
- •AFC >12 and AMH>1.5 ng/ml
- •BMI 19-28kg/m2
- •Body weight >60kg
- •Both ovaries present
- •Willing to participate in the study
- •Willing to use non-hormonal contraception or not needing contraception Recipients will be eligible only if their partners' sperm which will be used for ICSI will be normal. Couples will be excluded in case of moderate to severe oligoasthenospermia.
排除标准
- •Endometriosis
- •Low ovarian reserve
- •Endocrine abnormalities
- •Hormonal contraception
- •Contraindication of hormonal treatment
- •History of Ovarian Hyperstimulation Syndrome or hyper-response (> 30 follicles .
研究组 & 干预措施
Early follicular phase protocol
On day 2 or 3 of the menstrual cycle, following baseline blood sampling, a single SC injection of 150 ìg corifollitropin alfa will be administered (Stimulation Day 1). Starting on Stimulation Day 6, the subject will receive a daily SC injection of 0.25 mg ganirelix up to and including the day of GnRH agonist triggering administration to prevent premature LH surges. From Stimulation Day 8 onwards treatment is continued with a daily SC dose of rFSH (200IU/day) up to the day of GnRHa administration.
干预措施: Follicular phase corifollitropin alfa (Drug)
Luteal phase protocol
Following baseline blood sampling on cycle day 2 of 3 of the menstrual cycle, patients will be followed up with blood and ultrasound from cycle day 10 onwards till the detection of serum LH peak. LH peak will be defined as an increase in serum LH above 20IU/LH. Five (5) days after the LH peak a single SC injection of 150 ìg corifollitropin alfa will be administered (Stimulation Day 1). Starting on Stimulation Day 6, the subject will receive a daily SC injection of 0.25 mg ganirelix up to and including the day of GnRH agonist triggering administration to prevent premature LH surges. From Stimulation Day 8 onwards treatment is continued with a daily SC dose of rFSH (200IU/day) up to the day of GnRHa administration.
干预措施: Luteal phase corifollitropin alfa (Drug)
结局指标
主要结局
Mean number of euploid embryos
时间窗: 15-45 days following oocyte retrieval procedure
Number of euploid embryos between oocytes received from follicular phase or luteal phase initiation of ovarian stimulation.
次要结局
- Number of oocytes(9 -20 days from initiation of ovarian stimulation)
- Total additional dose of rFSH (IU)(9 -20 days from initiation of ovarian stimulation)
- Duration of ovarian stimulation(9 -20 days from initiation of ovarian stimulation)
- Endocrine profile at specific intervals(Stimulation day 1, day 6, day 8, and Day of final oocyte maturation (actual day may vary between 9-15))
- Number of MIIs(9 -20 days from initiation of ovarian stimulation)
- Clinical pregnancy rates following transfer of embryos generated from oocytes from follicular phase vs. luteal phase stimulation(5-8 weeks after embryo transfer procedure)
研究者
Nikolaos Polyzos
Clinical and Scientific Director
Institut Universitari Dexeus