A Prospective, Multicenter, Double-blind, Placebo-controlled, Phase III Clinical Study, on the Efficacy and Safety of Low-dose hCG in a Short Protocol With GnRH Agonist and Ovarian Stimulation With Recombinant FSH (rFSH) During the Follicular Phase in Subfertile Women Undergoing ART
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The rate of clinical pregnancy
研究概览
简要总结
The objective of this prospective randomized clinical trial is to investigate whether the addition of low-dose hCG to a short GnRH-agonist protocol for IVF and ovarian stimulation with rFSH from the onset of the follicular phase and throughout stimulation in sub fertile women undergoing IVF, improves pregnancy rates.
详细描述
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, two parallel group of patients, Phase IIIb clinical study to test the efficacy and safety of adding low-dose hCGs in a short protocol with GnRH agonist and ovarian stimulation with recombinant FSH (rFSH) from the onset of the follicular phase and throughout the duration of stimulation in enrolled women to the increase in the rate of clinical pregnancies.
Main end point will be the rate of clinical pregnancy (positive heart rate at 7 weeks of gestation in the ultrasound), while secondary endpoints will be
- The number of follicles (> 11,> 14,> 18 mm) on the day of triggering with hCG
- The thickness of the endometrium on the day of follicular maturation
- Live birth rates
- Automatic abortion rates (loss of pregnancy after positive heart function up to 20 weeks of gestation)
- The rate of ongoing pregnancy (positive heart function after 12 weeks of gestation),
- The percentage of ovarian hyperstimulation syndrome (after triggering) with hCG for the next 2 weeks
- The rate of multiple pregnancy.
Participants will be randomly divided into two groups: the intervention group (Group 1) and the control group (Group 2). Randomization will be done using sealed envelopes marked "Group 1" and "Group 2". The randomization list will be prepared centrally for the four participating clinics (research centers) and there will be a "stratification" per center, per 30, respectively, and will be shared among the participants.
"Group 1" will indicate the application of the protocol by adding hCG with the initiation of controlled ovarian stimulation protocol for IVF / ICSI with rFSH, and "Group 2" will indicate the application of the conventional protocol without the addition of hCG .
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: between 35 and 40 years of age,
- •Physiological menstrual cycles (24-35 day cycle),
- •Normal endocrine function (normal PRL and TSH, FSH ≤ 15 IU / ml),
- •Transvaginal ultrasound (TVS) without pathological findings,
- •Free personal medical history,
- •Indication for IVF / ICSI (NICE, 2016)
- •1st or 2nd IVF / ICSI cycle
排除标准
- •Endocrine or metabolic disorders, e.g. PCO (S)
- •Pathology of the uterus and / or endometrium,
- •Pelvic inflammatory disease (PID),
- •Basal FSH levels> 15 IU / ml,
- •Surgery in the ovaries,
- •Body Mass Index (BMI) ≥ 35 kg / m2,
- •Age: <35 years &> 41 years old
研究组 & 干预措施
Group 1 [HCG (+) group]
"Group 1" will indicate the application of the protocol by adding hCG with the initiation of standard GnRH agonist protocol for IVF / ICSI with rFSH
干预措施: hCG (Drug)
Group 2 [placebo]
"Group 2" will indicate the application of the standard GnRH agonist protocol without the addition of hCG, but placebo, instead
干预措施: Placebo (Drug)
结局指标
主要结局
The rate of clinical pregnancy
时间窗: 7 weeks after the initiation of treatment
Positive heart rate at 7 weeks of gestation in ultrasound
number of transferred embryos
时间窗: 21 days after the beginning of ovarian stimulation
number of high quality transferred embryos at day 3
次要结局
- The thickness of the endometrium(2 weeks after the initiation of treatment)
- Automatic abortion rates - miscarriage(up to 20 weeks of gestation)
- Number of follicles(2 weeks after the initiation of treatment)
- The percentage of ovarian hyperstimulation syndrome(2 weeks after the hCG triggering)
研究者
Siristatidis Charalampos, MD, PhD
Associate Professor in Obstetrics and Gynecology
National and Kapodistrian University of Athens