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临床试验/NCT02140515
NCT02140515Unknown4 期

Comparison of Assisted Reproductive Technology (ART) Outcomes Between Two Protocols of Induction of Ovulation by Using Recombinant Luteinizing Hormone (rLH) and Recombinant Follicle Stimulating Hormone (rFSH) in Patients With Hypogonadotropic Hypogonadism

Royan Institute1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
90
试验地点
1
主要终点
number of follicles

研究概览

简要总结

We wanted to compare the Assisted Reproductive Technology (ART) outcomes between two protocols of induction of ovulation in patients with Hypogonadotropic Hypogonadism. In the beginning, all patients receive Recombinant Follicle Stimulating Hormone (Gonal-F) and Recombinant Luteinizing Hormone (Luveris). When at least one follicle reaches 14 mm in diameter, Luveris alone is administered for group A and both drugs Gonal-F and Luveris for group B. Finally Assisted Reproductive Technology (ART) results are compared between the two groups.

详细描述

In this single blind randomized clinical trial, 90 women with a clinical history of hypogonadotrophic hypogonadism who stopped any treatment with gonadotrophins >1 month before study, with a negative progesterone challenge test, low serum gonadotrophins (Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) less than 5.0 IU/l) and oestradiol (less than 100 pg/ml) and normal serum concentrations of thyroid stimulating hormone (TSH), testosterone and prolactin within 6 months before the start of treatment are studied in the Royan Institute. Other causes of infertility are excluded from the study. All patients receive treatment with recombinant follicle stimulating hormone (Gonal-F) and recombinant luteinizing hormone (Luveris). When at least one follicle reaches 14 mm in diameter, 4mg/day oestradiol is administered and patients are randomly divided into two groups: Luveris alone (intervention group) and continued treatment with both drugs Gonal-F and Luveris (control group). When at least one follicle detects a mean diameter of ≥18 mm and serum estradiol level reaches 500-2000 pg/ml, ovarian stimulation is stopped and injection of 10000 IU Human Chorionic Gonadotrophin (hCG) is administrated.

At the end, the number and size of ovarian follicles, endometrial thickness on the day of injection of Human Chorionic Gonadotrophin (hCG), the number of oocytes retrieved, the number of good quality embryos, chemical and clinical pregnancy rate, fertilization rate and implantation rate will be compared between the two groups.

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 (Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • Have a clinical history of hypogonadotropic hypogonadism, and laboratory test result comply with diagnosis of hypogonadotropic hypogonadism
  • Have discontinued gonadotropins or gonadotropin releasing hormone or estrogen-progesterone replacement therapy at least one month before the study
  • Have primary or secondary amenorrhea
  • Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) <5.0 IU/l and oestradiol <100 pg/ml before initiation of treatment
  • Have a negative progesterone challenge test
  • Normal serum concentrations of thyroid stimulating hormone (TSH), prolactin and testosterone within 6 months before the start of study
  • Be willing and able to comply with the protocol for the duration of the study
  • Have given written informed consent prior to any study related procedure

排除标准

  • The other causes of infertility.
  • History of ovarian hyper stimulation syndrome
  • Abnormal gynecological bleeding of undetermined origin
  • Previous or current hormone dependent tumor

研究组 & 干预措施

Luveris

Active Comparator

Evaluation the effect of Luveris protocol on Induction of ovulation in Patients with Hypogonadotropic Hypogonadism

干预措施: Lutropin alfa (Drug)

Gonal-F& Luveris

Active Comparator

Evaluation the effect of Gonal-F& Luveris protocols of Induction of ovulation in Patients with Hypogonadotropic Hypogonadism

干预措施: Follitropin alfa and Lutropin alfa (Drug)

结局指标

主要结局

number of follicles

时间窗: baseline

Evaluation thre number follicles before injection of Human Chorionic Gonadotrophin (hCG)

Size of follicle

时间窗: baseline

Evaluation the size of follicle before injection of Human Chorionic Gonadotrophin (hCG)

Endometrial thickness

时间窗: 1day

Evaluation the endometrial thickness at the day of injection of Human Chorionic Gonadotrophin (hCG)

次要结局

  • number of oocytes retrieved(3 days)
  • Fertilization rate(2 days)
  • Clinical pregnancy rate(4 weeks)
  • Implantation rate(4 weeks)
  • Biochemical pregnancy rate(2 weeks)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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