NCT00334425Unknown4 期
The Effect of LH-Priming During Early Follicular Phase on Ovarian Response and Pregnancy Outcome in GnRHa Down-Regulated Women, Stimulated With Exogenous Gonadotrophins in IVF Treatment
Central Jutland Regional Hospital2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2006年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Circulatory levels of Estradiol on the day of hCG
研究概览
简要总结
To evaluate the effect of LH-activity supplementation during the early follicular phase in GnRHa down-regulated women undergoing IVF in terms of S-Estradiol levels on hCG day by comparing different combinations with HP-HMG and r-FSH.
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 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females between the ages of 18- 38 years (both included) at the time of randomisation
- •Patients for whom treatment with gonadotrophins and GnRH agonist (long protocol) in IVF setting is considered appropriate according to the criteria of the participating centre
- •Infertility for at least 1 year before randomisation (except for tubal infertility)
- •A maximum of two previous consecutive unsuccessful IVF cycles (i.e. not resulting in an ongoing pregnancy
- •25- 34 days of menstruation cycle
- •Body mass index (BMI) < 29 kg/m2
排除标准
- •Any clinically significant systemic disease (e.g., insulin dependent diabetes)
- •Endocrine or metabolic abnormalities (pituitary, adrenal, thyroid, pancreas, liver, or kidney) which can compromise participation in the study
- •Any concomitant medications that would interfere with evaluation of study medications. Specifically, any non-study hormonal therapy (except for thyroid medication), prostaglandin inhibitors (NSAIDs, including aspirin) and psychotropic agents (phenothiazine's, major tranquillisers) at the time of study entry. Note: these medications are disallowed for the study duration.
- •Presence of clinically significant uterine fibroids
- •Undiagnosed vaginal bleeding
- •Tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
- •Pregnancy, lactation or contraindication to pregnancy - must be confirmed by negative urinary pregnancy test at randomisation
结局指标
主要结局
Circulatory levels of Estradiol on the day of hCG
次要结局
- Total number of follicles as well as the numbers of follicles <10mm, 10-14 mm, >14mm day during gonadotrophin treatment and at the end of stimulation prior to hCG injection
- E2 per follicle >14 mm
- Total number of oocytes retrieved
- fertilization rate
- serum hCG > 10 IU/l on day 12-14 after embryo transfer
- implantation rate
- transferable embryos
- Clinical pregnancy rate
- Ongoing pregnancy rate
- embryo quality
- Serum; LH, FSH, Androstenedione, Progesterone, hCG and Inhibin-B. Progesterone seven days after ET day
- Intra follicular levels of; endocrine parameters
- Endometrial thickness; hCG day (minus 0-2 days)
- Total gonadotrophin dose administered
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
1 期
The effect of LH priming in early follicular phase on the endocrinological function of the ovary and pregnancy rate in GnRh downregulated women stimulated by exogen gonadotophins in IVF-treatmentInfertilityEUCTR2005-002679-34-DKThe Fertility Clinic, Sygehus Viborg (Skive)150
已完成
4 期
Early Follicular Supplementation of Ganirelix in IVF 2004IVF TreatmentInfertilityNCT00461422The Baruch Padeh Medical Center, Poriya50
Unknown
4 期
GnRH Antagonist Pre-treatment in the Early Follicular Phase for Resolution of a Baseline Functional Ovarian CystOvarian CystsIVFNCT04993924Assaf-Harofeh Medical Center15
Unknown
4 期
GnRH Antagonist Pre-treatment for the Prevention of Asynchronous Follicular GrowthIVFNCT05071339Assaf-Harofeh Medical Center15
已完成
4 期
GnRH Agonist and Intrauterine InseminationIntrauterine InseminationNCT00503217Instituto Valenciano de Infertilidad, IVI VALENCIA