NCT01956123已完成3 期
A Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Evaluating the Immunogenicity of FE 999049 in Repeated Cycles of Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 513
- 试验地点
- 13
- 主要终点
- Proportion (Percentage) of Subjects With Treatment-induced Anti-Follicle-Stimulating Hormone (FSH) Antibodies After up to Two Repeated Controlled Ovarian Stimulation Cycles
研究概览
简要总结
This trial investigates the immunogenicity of FE 999049 in repeated cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed Consent Documents signed prior to screening evaluations related to this protocol
- •Participation in the pivotal efficacy trial (trial 000004/ESTHER-1)
- •Anti-FSH antibody results from baseline and at least one post-dosing assessment in the previous cycle(s) available.
- •Having undergone the oocyte retrieval procedure, or having had cycle cancellation prior to oocyte retrieval due to poor ovarian response or excessive ovarian response, in the previous cycle(s).
- •Failure to achieve ongoing pregnancy in the previous cycle(s).
排除标准
- •Non-compliance to protocol compliance in the previous cycle(s).
- •Having undergone any stimulation with gonadotropins since the end-of-trial / end-of-cycle visit in the previous cycle
- •One or more follicles ≥10 mm observed on the transvaginal ultrasound prior to start of dosing on stimulation day 1
- •Severe OHSS in a previous cycle.
- •Any clinically relevant change to any of the eligibility criteria in the previous cycle(s).
- •Clinically relevant medical history since the previous cycle which precludes gonadotropin stimulation or is associated with a reduced chance of pregnancy.
研究组 & 干预措施
A
Experimental
Follitropin Delta (FE 999049) (COS cycle 2)
干预措施: Follitropin Delta (FE 999049) (Drug)
B
Active Comparator
Follitropin Alfa (GONAL-F) (COS cycle 2)
干预措施: Follitropin Alfa (GONAL-F) (Drug)
C
Experimental
Follitropin Delta (FE 999049) (COS cycle 3)
干预措施: Follitropin Delta (FE 999049) (Drug)
D
Active Comparator
Follitropin Alfa (GONAL-F) (COS cycle 3)
干预措施: Follitropin Alfa (GONAL-F) (Drug)
结局指标
主要结局
Proportion (Percentage) of Subjects With Treatment-induced Anti-Follicle-Stimulating Hormone (FSH) Antibodies After up to Two Repeated Controlled Ovarian Stimulation Cycles
时间窗: Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose
The proportion (percentage) of participants with at least one treatment-induced anti-FSH antibody response at any time point is presented. The cumulative incidences in COS cycle 2 and COS cycle 3 divided by participants in COS cycle 2 are presented. Participants with observations in both cycles are only counted once.
次要结局
- Proportion (Percentage) of Subject With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response for Each Controlled Ovarian Stimulation Cycle(End-of-stimulation (up to 20 stimulation days))
- Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies With Neutralising Capacity After up to Two Repeated Controlled Ovarian Stimulation Cycles(Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose)
- Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralising Capacity, After One and After Two Repeated Controlled Ovarian Stimulation Cycles(Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose)
- Proportion (Percentage) of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS for Each Controlled Ovarian Stimulation Cycle(≤9 days after triggering of final follicular maturation.)
- Vital Pregnancy Rate for Each Controlled Ovarian Stimulation Cycle(5-6 weeks after blastocyst transfer)
- Implantation Rate for Each Controlled Ovarian Stimulation Cycle(5-6 weeks after blastocyst transfer)
- Ongoing Implantation Rate for Each Controlled Ovarian Stimulation Cycle(10-11 weeks after blastocyst transfer)
- Proportion (Percentage) of Subjects With Late OHSS (Including OHSS of Moderate/Severe Grade) for Each Controlled Ovarian Stimulation Cycle(>9 days after triggering of final follicular maturation)
- Technical Malfunctions of the Administration Pen for Each Controlled Ovarian Stimulation Cycle(End-of-stimulation (up to 20 stimulation days))
- Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Subject During the Stimulation Period for Each Controlled Ovarian Stimulation Cycle(End-of-stimulation (up to 20 stimulation days))
- Ongoing Pregnancy Rate for Each Controlled Ovarian Stimulation Cycle(10-11 weeks after blastocyst transfer)
研究者
研究点 (13)
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