NCT01029470Unknown2 期
A Multicentre, Prospective, Open Study to Describe the Effects of rhLH Supplement in Women With Hyporesponse to rFSH After Pituitary Downregulation.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of oocyte retrieved
研究概览
简要总结
Primary objective:
To evaluate the efficacy in terms of oocyte retrieval number of rLH supplement in women with hyporesponse to rFSH after pituitary downregulation.
Secondary objective:
To further explore the efficacy of rLH supplement in women with hyporesponse to rFSH after pituitary downregulation To evaluate the safety of rLH supplementation in hyporesponse women
详细描述
Primary endpoint:
Number of oocyte retrieved
Secondary endpoints:
- Oestrodial on hCG day (pg/ml)
- Number of embryos
- Implantation rate (%)
- Clinical pregnancy rate (%)
- Ongoing PR per IVF cycle (%)
- Abortion rate (%)
- Ampoules of rFSH
- FertiQoL score Safety endpoint: adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •20-40 years old women
- •With menstrual cycles ranged 24-35 days, intraindividual variability±3 days
- •Basal FSH <10 IU/L at cycle D2-D5
- •18 < BMI < 30
- •Presence of two ovaries
- •No ovarian stimulation over the past 3 months
- •Signed inform consent form.
排除标准
- •Polycystic ovarian syndrome
- •rAFS stage Ⅲ-Ⅳ endometriosis
- •Chromosomal abnormalities, endocrinological and/or autoimmune disorders.
- •More than two previously unsuccessful IVF.
研究组 & 干预措施
Luveris
Experimental
Those subjects who experience hyponresponse to FSH stimulation during mid-follicle phase after pituitary downregulation will receive Luveris 75IU or 150IU IH injection daily till HCG day.
干预措施: Luveris (Drug)
结局指标
主要结局
Number of oocyte retrieved
时间窗: 2009Dec-2010Oct
次要结局
- 1. Oestrodial on hCG day (pg/ml) Safety: adverse events(2009 Dec-2010 Oct)
- 2. Number of embryos(2009 Dec-2010 Oct)
- 3. Implantation rate (%)(2009 Dec-2010 Oct)
- 4. Clinical pregnancy rate (%)(2009 Dec-2010 Oct)
- 5. Ongoing PR per IVF cycle (%)(2009 Dec-2010 Oct)
- 6. Abortion rate (%)(2009 Dec-2010 Oct)
- 7. Ampoules of rFSH(2009 Dec-2010 Oct)
- 8. FertiQoL score Safety: adverse events(2009 Dec-2010 Oct)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Phase III Study of FE 999913 in Japanese Female Patients Undergoing Fertility TreatmentLuteal Hormone SupplementationNCT01710514Ferring Pharmaceuticals108
已完成
4 期
The Evaluation of Recombinant LH Supplementation in Patients With Suboptimal Response to Recombinant FSH Undergoing ICSIInfertilityNCT02108223Sisli Hamidiye Etfal Training and Research Hospital137
已完成
3 期
Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive TreatmentInfertility, FemaleNCT03088137IVFarma LLC118
已完成
4 期
The Effect of Luteinizing Hormone (LH) Supplementation Following Gonadotropin-releasing Hormone (GnRH) Antagonist Administration in Advanced Reproductive Ageing Women Undergoing IVF and Embryo Transfer (IVF/ET)Pregnancy Result RapeNCT01016210The Baruch Padeh Medical Center, Poriya60
已完成
2 期
Investigation of Three Contraceptive Hormone Patches in Regard to Inhibition of Ovulation Following Application Over 3 Treatment Cycles in Healthy, Young Women.ContraceptionNCT01204190Bayer173