Prospective Randomized Open Label Study to Compare the Efficacy and Safety of Ovarian Stimulation With Pergoveris® and Menopur® in Women With Severe Luteinizing Hormone (LH) and Follicular Stimulating Hormone (FSH) Deficiency.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- E2 in pmol/L
研究概览
简要总结
The aim of the study is to compare the efficacy and safety of r-hFSH+r-hLH in a 2:1 ratio with human Menopausal Gonadotropin Highly Purified (hMG-HP), in WHO type I anovulation, HH women.
This open-label monocentric, randomized comparative trial, to receive the two different standard clinical practice treatments:
- 1 vial of Pergoveris: (vial/powder 150 International unit (IU) r-hFSH+ 75IU r-hLH)
- 2 vials of Menopur: (vials/powder hMG 75IU).
Follicular development were monitored until the protocol hCG requirement is met and a single injection of hCG was administered.
Main Outcome Measures were follicular development i.e. follicle ≥ 17 millimeters (mm), pre-ovulatory E2 ≥ 400 picomole/Liter (pmol/L) and mid-luteal phase Progesterone (P4) ≥ 25 nanomole/Liter (nmol/L).
详细描述
World Health Organization (WHO) type I hypogonadotropic anovulation (hypogonadotropic hypogonadism, HH) is a rare alteration of the reproductive system with absent or decreased function of the gonads, caused by congenital, including genetic, or acquired reduced hypothalamic or pituitary activity. This results in abnormally low serum levels of Follicular Stimulation Hormone (FSH) and Luteinizing Hormone (LH) and negligible oestrogen (E2) activity.
The most convenient treatment is daily injections of exogenous gonadotropins that has been proven to be effective.
Patients lacking an effective hypothalamic-pituitary activity (WHO type I anovulation) do not produce sufficient threshold levels of endogenous LH, which is required to obtain optimal follicular development and steroidogenesis when treated with FSH alone. Therefore a combination therapy with adequate doses of both FSH and LH in an optimal ratio is required in order to restore fertility.
The LH activity could be produced by LH itself or by human Chorionic Gonadotropin (hCG) and the two gonadotropins are available to be used in the WHO type I patients in two different formulations both in indication for this type of patients. It would be worth of interest to assess if these two different formulations could elicit the same clinical outcomes in standard clinical practice or not.
The aim of the study is to compare the efficacy and safety of recombinant human FSH and recombinant human LH (r-hFSH+r-hLH) in a 2:1 ratio with human Menopausal Gonadotropin Highly Purified (hMG-HP), containing LH-like activity, in women with severe LH and FSH deficiency (WHO type I anovulation, HH).
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
- 25 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •WHO Type I HH Women
- •Serum LH <1.2 IU/L
- •Serum FSH <5 IU/L
- •Age 25-36 years
- •No ovarian tumor
- •≤ 13 small follicles (mean diameter ≤ 10mm)
- •BMI between 18 - 32 Kg/m2
- •no systemic diseases
排除标准
- 未提供
研究组 & 干预措施
Pergoveris: 150IU r-hFSH+ 75IU r-hLH
This is a prospective randomized study using two in-label treatments for the patient disease: Pergoveris and Menopur. Pergoveris arms can be considered as experimental for the aim of the study, anyway it is standard routine practice for HH women.
干预措施: Pergoveris: 150IU r-hFSH + 75IU r-hLH (Drug)
Menopur: hMG-HP (150IU)
This is a prospective randomized study using two in-label treatments for the patient disease: Pergoveris and Menopur. Menopur can be considered as experimental for the aim of the study, anyway it is standard routine practice for HH women
干预措施: Menopur: HMG-HP (150 IU) (Drug)
结局指标
主要结局
E2 in pmol/L
时间窗: Day after the protocol hCG requirement is met (at least one follicle of 17mm is monitored by ultrasound)
Evaluate the patients steroidogenesis
Number of Follicles > 17mm
时间窗: last US day before hCG administration
To evaluate the efficacy of the stimulation and maturity of follicles
P4 in nmol/L
时间窗: Day after the protocol hCG requirement is met (at least one follicle of 17mm by US)
Progesteron level to evaluate the endometrial receptivity
次要结局
- Endometrial thickness(Day 5 and Day 10 of stimulation treatment)
- Total number of Follicles(Last US day before hCG administration)
- Clinical Pregnancy rate(days 35-42 post hCG)
- Occurence of any adverse events (early or late ovarian hyperstimulation syndrome)(Days 15-20 post hCG)
研究者
Domenico Carone
MD
Centro Riproduzione e Andrologia