NCT00971152已完成3 期
Effect of a Higher Than Maximum 450IU Gonadotropin Dose on Patient Outcomes in an In-Vitro Fertilization Setting: a Randomized Controlled Non-infertility Trial
Clinique Ovo1 个研究点 分布在 1 个国家目标入组 366 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- Number of metaphase II oocytes retrieved during the course of one treatment cycle
研究概览
简要总结
This goal of this study is to evaluate the outcomes from in vitro fertilization cycles where a 450 IU daily dose of gonadotropins is administered compared to those where a 600 IU daily dose is administered for women who are at risk of a poor ovarian response in order to determine if one dose or the other results in improved cycle outcomes.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •RESIDENT OF CANADA
- •Premenopausal
- •Age 40 years or less at the time of enrollment
- •At risk of a poor ovarian response defined as: either <5 oocytes or <8 follicles in a previous cycle, FSH > 10 IU/L, AMH < 1 pg/ml , antral follicle count less or equal to 8 or previous IVF cancellation
- •Primary infertility or secondary
- •Not previously undertaken a cycle that was included in this study
排除标准
- •Simultaneous participation in another clinical trial
- •Body mass index (BMI) > 38 kg/m2
- •Early follicular phase (day 2-4) serum FSH level > 20 mIU/ml
- •Any contraindication to being pregnant and carrying a pregnancy to term
- •Contraindication for the use of Estrace® , Suprefact®, Menopur®, Bravelle®, hCG, and luteal phase support medication
- •Any ovarian or abdominal abnormality that may interfere with adequate transvaginal ultrasound evaluation
- •Administration of any investigational drugs within three months prior to study enrollment
- •Patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study
- •Positive results of screening of either partner for HIV antibodies, Hepatitis B (other than for surface antibodies present after vaccination) or Hepatitis C
- •Unwillingness to give written informed consent
研究组 & 干预措施
450 IU daily dose of gonadotrophin
Active Comparator
干预措施: menotropins for injection (Drug)
450 IU daily dose of gonadotrophin
Active Comparator
干预措施: urofollitropin for injection (Drug)
600 IU daily dose of gonadotrophin
Experimental
干预措施: menotropins for injection (Drug)
600 IU daily dose of gonadotrophin
Experimental
干预措施: urofollitropin for injection (Drug)
结局指标
主要结局
Number of metaphase II oocytes retrieved during the course of one treatment cycle
时间窗: 2 years
次要结局
- rate of occurrence of ovarian hyperstimulation syndrome (OHSS)(2 years)
- Number of follicles recruited per patient during stimulation(2 years)
- Fertilization rate per patient (number of normally fertilized (with 2 pronuclei) oocytes/number of mature oocytes collected)(2 years)
- Embryo cleavage rate per patient (number of divided normally fertilized oocytes/number of normally fertilized oocytes)(2 years)
- Number of supernumerary embryos available for cryopreservation per patient(2 years)
- Implantation rate(2 years)
- Biochemical pregnancy rate(2 years)
- Clinical pregnancy rate(2 years)
- Rate of multiple gestation(2 years)
- Number of embryos available per patient(2 years)
- Ongoing pregnancy rate(2 years)
- Live birth rate(2 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Effect of Gonadotropin Types and Indications on Homologous Intrauterine Insemination SuccessInfertilityNCT03669276Centre Hospitalier Universitaire, Amiens1,251
已完成
不适用
Early Luteal Hormones and IVF Outcomes After hCG TriggeringLuteal Phasein Vitro FertilisationNCT04693624Mỹ Đức Hospital95
Unknown
不适用
CuMulativE Live bIrth Rate of Patients at High Risk of OHSS After Freeze-all Embryos at Cleavage or blAstocyst StageInfertilityNCT03817060Université Libre de Bruxelles128
已完成
早期 1 期
Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome PreventionComplications Associated With Artificial FertilizationDisorder of Endocrine OvaryNCT01530490Hospital de Cruces80
撤回
4 期
IVF Versus Gonadotropin Therapy in Women With CC Resistant PCOSInfertilityPolycystic Ovarian SyndromeNCT02458963Mohamed Sayed Abdelhafez