A Phase II, Multicentre, Multinational, Randomised, Assessor-Blind Trial to Investigate the Efficacy and Safety of Various Dosages of FSH-GEX™ in Comparison With 150 IU Gonal-f® in Women Undergoing ICSI Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 2
- 主要终点
- Number of follicles
研究概览
简要总结
The aim of the current study was the determination of the recommended standard treatment dose of FSH-GEX(TM) in women undergoing intracytoplasmic sperm injection (ICSI) treatment as assessed by follicle growth.
详细描述
This was a phase II, randomized, assessor-blind, comparator-controlled, multiple dose study in women undergoing ICSI treatment.
The primary objective of the study was the determination of the recommended standard treatment dose of FSH-GEX™ as assessed by follicle growth dynamics in women between 18 and 37 years of age who were undergoing intracytoplasmic sperm injection treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient for whom ICSI treatment is justified
- •Serum follicle-stimulating hormone concentration
- •Anti-mullerian hormone concentration
- •Antral follicle count
- •Body mass index and body weight
- •Presence of both ovaries
- •Regular spontaneous cycles between 21 and 35 days in length
- •Normal uterine cavity as assessed by transvaginal sonography at Screening
- •Willing and able to comply with the protocol
- •Willing and able to provide written informed consent
排除标准
- •Patients who had more than two unsuccessful previous assisted reproduction technology cycles before inclusion into the study
- •Previous poor responders
- •Patients with previous hyperstimulation syndrome or cycle cancellation because of imminent hyperstimulation syndrome
- •Patients with a history of or current polycystic ovarian morphology syndrome
- •Patients with a history of or current endometriosis III or IV
- •Presence of ovarian cyst at Screening
- •Any contraindication to becoming pregnant
- •History of ≥ 3 clinical or preclinical miscarriages
- •Abnormal cervical smear, Papanicolaou [PAP] score ≥ 3
- •Any history of malignant cancer other than in situ breast or skin cancer requiring local excision
- •Any endocrine abnormalities requiring treatment
- •Any clinically significant systematic disease
- •Any known infection with human immunodeficiency virus, hepatitis B or C
- •History of thrombosis or other risk factors including any coagulation abnormality leading to an increased risk of clotting
- •Family history of genetic risk factors concerning pregnancy or birth
- •Use of concomitant medication, which in the opinion of the investigator might interfere with ICSI preparation procedures
- •Active smoking
- •Any active substance abuse of drugs, medications or alcohol within the last five years
- •Patients in an institution by official or court order
- •Patients who are unable or unwilling to provide informed consent
- •Any participation in another clinical trial within the last 60 days before randomisation
- •Previous FSH-GEX™ administration.
- •Known hypersensitivity to any component of the investigational and non investigational products used in this study
研究组 & 干预措施
treatment 1
Follitropin Epsilon 52.5 IU quaque die (QD) s.c.
干预措施: Follitropin Epsilon (Drug)
treatment 2
Follitropin Epsilon 75 IU QD s.c.
干预措施: Follitropin Epsilon (Drug)
treatment 3
Follitropin Epsilon 112.5 IU QD s.c.
干预措施: Follitropin Epsilon (Drug)
treatment 4
Follitropin Epsilon 150 IU QD s.c.
干预措施: Follitropin Epsilon (Drug)
treatment 5
Follitropin Epsilon 150 IU quaque altera die (QAD) s.c.
干预措施: Follitropin Epsilon (Drug)
treatment 6
Follitropin alfa 150 IU QD s.c.
干预措施: Follitropin Alfa (Drug)
结局指标
主要结局
Number of follicles
时间窗: day of hCG injection; variable timeframe; up to 18 days for maximum
The number of follicles with a diameter of ≥ 12 mm on the day of human chorionic gonadotropin (hCG) injection after stimulation with follicle stimulating hormone (FSH)
次要结局
- Cumulus-oocyte-complexes(at oocyte retrieval; 32 - 36 hours after hCG injection)
- Oocytes retrieved(at oocyte retrieval; 32 - 36 hours after hCG injection)
- Follicular response(every second day up to hCG injection; variable timeframe; up to 18 days for maximum)
- Two pronuclei oocytes(one day after oocyte retrieval)
- Biochemical pregnancy rate(14 to 20 days after oocyte retrieval)
- Clinical pregnancy rate(approx. 4 to 6 weeks after last FSH dose)
- Implantation rate(approx. 4 to 6 weeks after last FSH dose)
- Estradiol and inhibin B serum levels(every second day up to hCG injection; variable timeframe; up to 18 days maximum)
- Adverse events, ovarian hyperstimulation syndrome, anti-drug-antibodies, overall tolerability(up to 4 to 6 weeks after last FSH dose)
- Number of doses and total dose of FSH(variable timeframe; up to 18 days for maximum)