Interest of Estrogen Scheduling Before Ovarian Stimulation With Corifollitropin Alfa in Women Older Than 38 Years Old Undergoing in Vitro Fertilization
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 334
- 试验地点
- 3
- 主要终点
- Number of selected oocytes
研究概览
简要总结
E2 given in late luteal phase can be extended beyond the onset of menses for a period of at least eight days before the start of the stimulation, allowing scheduling of stimulation in order to limit oocytes retrievals during weekends .
Administration of corifollitropin alfa, a Follicule stimulating Hormone (FSH) with extended release kinetics, seems particularly interesting for a synchronous recruitment of follicles after homogenization of the cohort.
The objective of this study is to evaluate the impact on the response to ovarian stimulation with corifollitropin alfa of E2 scheduling versus no scheduling for women over 38 years, age at which declining of ovarian reserve usually begins. The management of these patients in terms of organization of the center is also evaluated.
The scheduling of IVF cycles represents a double benefit. On one hand, to enable a "synchronization" of the follicular cohort for a best response and a higher number of mature oocytes. On the other hand, a more efficient organization for both the center (avoiding retrievals on weekends and public holidays, organize and distribute equally the activity, reduce cost operations) and couples (personal and professional organization).
详细描述
With advanced age, ovarian reserve decreases, follicular cohort becomes heterogeneous under the influence of higher FSH rise in late luteal phase. It has been shown that estrogens (E2) taken in the late luteal phase homogenized follicular cohort by inhibiting inter cycle FSH peak ,and that this inhibition is immediately reversible after discontinuation of treatment .
E2 given in late luteal phase can also be extended beyond the onset of menses for a period of at least eight days before the start of the stimulation, allowing scheduling of stimulation in order to limit oocytes retrievals during weekends . A prospective randomized study comparing E2 scheduling and no scheduling has shown that there was no difference in birth rate in a population of normo-responders women . While in these patients, the number of oocytes was not different in the two arms, a recent pilot study founded a significant increase in the number of oocytes retrieved after E2 luteal phase priming compared to the absence of priming in a population of poor responders .
In 2013, a report of the French governmental BioMedicine Agency warned about the thrombo-embolic risk associated with the use of the contraceptive pill for IVF scheduling, especially in women over 35.
Administration of corifollitropin alfa, an FSH with extended release kinetics, seems particularly interesting for a synchronous recruitment of follicles after homogenization of the cohort. In the Pursue study, an equivalent efficacy has been shown with the daily administration of 300 IU FSH and corifollitropin alfa in patients over 35 years .
The objective of this study is to evaluate the impact of the response to ovarian stimulation with corifollitropin alfa of E2 scheduling versus no scheduling for women over 38 years, age at which declining of ovarian reserve usually begins. The management of these patients in terms of organization of the center is also evaluated.
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
- 38 Years 至 47 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient of 38 years or more
- •Planned in invitro fertilization or intracytoplasmic sperm injection rank 1 or 2 (rank = retrieval with transfer)
- •With regular cycles from 26 to 35 days
- •Weight > 50 kg and body mass index< or equal to 32
- •Affiliation to the general system of French social security and reimbursement for fertility problems
排除标准
- •Irregular cycles and/or polycystic ovarian syndrome
- •Previous History of ovarian hyperstimulation syndrome
- •Rank puncture > 2
- •Uterine malformation
- •Presence of hydrosalpinges
- •Endometriosis stage III or IV
研究组 & 干预措施
Arm E2: With estrogens pretreatment
The estrogens pretreatment will began between the day 20 and the day 24 of an ovarian cycle and should be continued until Wednesday beyond the onset of menses
干预措施: Estrogens (Drug)
结局指标
主要结局
Number of selected oocytes
时间窗: At time of ovarian puncture
次要结局
- ongoing pregnancy rate(12 weeks after embryo transfer)
- Number of days of pretreatment(From inclusion visit date to the beginning of stimulation, up to 15 days)
- Number of days of antagonist(From date of stimulation until the date of the trigger, up to 30 days)
- Follicles number > 14 mm(From 1 day before the day of trigger or the day of trigger)
- Total number of embryos with good quality(At time of fertilization procedure)
- Cancellation rate(From date of inclusion visit until the date of embryo transfer, up to 90 days)
- Luteinizing hormone rate(8 days from the beginning of stimulation and the day of the trigger)
- Follicles number > 10 mm(8 days from the beginning of stimulation)
- early pregnancy(14 days after embryo transfer)
- The day of the trigger(At time of the trigger)
- Estradiol rate(8 days from the beginning of stimulation and the day of the trigger)
- Number of oocytes in metaphase 2(At time of ovarian puncture)
- Progesterone rate(8 days from the beginning of stimulation and the day of the trigger)
- miscarriage before 12 weeks of amenorrhea(From embryo transfer to 12 weeks after embryo transfer)
研究者
Anne GUIVARC'H-LEVEQUE
Reproductive Endocrinologist
Centre Hospitalier Intercommunal Creteil