Dysregulation of Follicle Stimulating Hormone (FSH) in Obesity: Functional and Statistical Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Difference Between Peak Inhibin B
研究概览
简要总结
Excess maternal weight, especially obesity, influences almost every aspect of fertility, from conception to problems during pregnancy. The investigators will use novel statistical methods to clarify the hormonal changes behind reproductive health conditions. A better understanding of reproductive hormonal changes in obese women may offer a way to identify new treatments.
详细描述
Hypothesis. Insufficient FSH (Follicle-stimulating hormone) pulsatility, as seen in obesity, results in inadequate folliculogenesis and reduced ovarian steroid and protein production.
AIM: To test the hypothesis that insufficient FSH pulsatility, as seen in obesity, results in inadequate folliculogenesis and reduced ovarian steroid and protein production. The investigators will determine if exogenous FSH administered in a pulsatile fashion results in a significant increase of ovarian hormones in obese women. Serial inhibin B and E2 levels will be measured in obese and normal weight women undergoing frequent blood sampling studies before and after GnRH (Gonadotropin-releasing hormone) antagonist blockade.
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
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 21 to 39 years old with regular menstrual cycles every 25-40 days
- •Body mass of 18.5 kg/m2-24.9kg/m2 (normal weight controls) or greater than 30.0 kg/m2 (obese group)
- •Prolactin and thyroid-stimulating hormone (TSH) within normal laboratory ranges at screening
- •Baseline hemoglobin >11 gm/dl.
排除标准
- •Diagnosis of polycystic ovary syndrome (PCOS), defined by the 2003 Rotterdam criteria as suggested by 2012 NIH Workshop
- •History of chronic disease affecting hormone production, metabolism or clearance or use of thiazolidinediones or metformin (known to interact with reproductive hormones)
- •Use of hormones affecting hypothalamic-pituitary-gonadal (HPO) axis (such as hormonal contraceptives) within 3 months of entry
- •Strenuous exercise (>4 hours of intense physical activity per week)
- •Pregnancy
- •Breast-feeding
- •Current attempts to conceive
- •Significant recent weight loss or gain
研究组 & 干预措施
Frequent Blood Sampling, Degarelix
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Degarelix (GnRH antagonist) blockade over a 2-day period. This arm was terminated due to Adverse Events and the study was continued with the Cetrorelix product.
干预措施: Degarelix (GnRH antagonist) (Drug)
Frequent Blood Sampling, Degarelix
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Degarelix (GnRH antagonist) blockade over a 2-day period. This arm was terminated due to Adverse Events and the study was continued with the Cetrorelix product.
干预措施: recombinant FSH (Drug)
Frequent Blood Sampling, Cetrorelix
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.
干预措施: recombinant FSH (Drug)
Frequent Blood Sampling, Cetrorelix
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.
干预措施: Cetrorelix (Drug)
结局指标
主要结局
Difference Between Peak Inhibin B
时间窗: Every 10 minutes over 2 10-hour frequent blood sampling sessions.
This is defined as the maximum hormone value during Day 1 of the study subtracted from the maximum hormone value during Day 2.
次要结局
- Peak Inhibin B Per Subject(Every 10 minutes over 10 hours on Day 1 and Day 2 of the study.)
- Peak E2 Per Subject(Every 10 minutes over 10 hours of Day 1 and Day 2 of the study.)