A Prospective, Observational Study on the Use of Cetrotide (GnRH Antagonist) With GONAL-f in Assisted Reproductive Technologies (ART)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,175
- 试验地点
- 1
- 主要终点
- Proportion of subjects achieving a clinical pregnancy.
研究概览
简要总结
This is a multicentric, prospective, observational study on the use of Cetrotide to control the endogenous gonadotrophin levels in Gonal-f stimulated ART treatment cycles in the Asia-Pacific region. The study plans to enrol approximately 1800-2000 subjects over a 9-month period at each participating centre.
This observational study is initiated to collect information on the use of Cetrotide (GnRH antagonist) in ART cycles in routine practice across the Asia-Pacific region. The information will allow a better understanding of the current ovarian stimulation regimens that involve Cetrotide in the control of the endogenous gonadotrophin concentrations. The collection of live birth data, though a challenging task, as a secondary endpoint will allow the study to show valuable information on the final objective of ART. To minimize the potential variability due to the different ovarian stimulation agents, the study is to include cycles treated with Gonal-f (recombinant human FSH) since this agent is widely available in the region.
详细描述
Gonadotrophin-releasing hormone (GnRH) antagonists were introduced in the beginning of this decade for the use in ART. The potential advantages of GnRH antagonists over the GnRH agonists include the avoidance of an acute stimulation of endogenous gonadotrophins and a dramatic reduction in the length of analogue treatment.
Despite the plus points of GnRH antagonists in ART, there has been some concern over the lower pregnancy rate reported, which may be the cause of a lower acceptance of GnRH antagonists in ovarian stimulation for in vitro fertilization (IVF). Interestingly, a separate meta-analysis did not reach the same finding. The probability of live birth after ovarian stimulation for IVF was found not to be dependent on the type of analogue used for pituitary suppression Cetrotide, a GnRH antagonist from Merck Serono, is currently approved for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian stimulation in majority of the regions. It is given either as a single-dose regimen of 3 mg injection or as a multiple-dose regimen of 0.25 mg daily injection. Both regimens have been shown to offer equivalent efficacy and safety outcomes.
OBJECTIVES:
Primary objective:
- To assess the effectiveness of Cetrotide regimens, when used with Gonal-f, in routine ART treatment cycles
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects who are undergoing ovarian stimulation for IVF or ICSI therapy
- •Decision by treating physician to prescribe Gonal-f for controlled ovarian stimulation prior to study enrolment
- •Decision by treating physician to prescribe Cetrotide as the down-regulation agent prior to study enrolment
排除标准
- •Subjects using GnRH agonist as the down-regulation agent
- •Contraindicated use of Cetrotide based on local label
- •Subjects who have participated in the study previously
- •Subjects with hypersensitivity to cetrorelix acetate, extrinsic peptide hormones or mannitol
- •Subjects with known hypersensitivity to GnRH or any other GnRH analogs
- •Subjects with known or suspected pregnancy, and lactation
结局指标
主要结局
Proportion of subjects achieving a clinical pregnancy.
时间窗: At post hCG days 35-42
A transvaginal ultrasound scan will be performed on all subjects who become pregnant provided that no miscarriage has occurred.
次要结局
- Number of oocytes retrieved(3 month)
- Proportion of women with OHSS or risk of OHSS(3 month)
- Duration and dose of Cetrotide administered(3 month)
- Pregnancy rate(12 month)
- Live birth rate(12 month)
- Assessment of baseline characteristics(3 month)
- Total dose of Gonal-f administered(3 month)
- Proportion of subjects with cancelled cycles(3 month)
- Duration of ovarian stimulation(3 month)
- Number of subjects with Adverse Events(3 month)