An Open-Label Randomized Controlled Trial (RCT) of 6 Weeks of Human Growth Hormone (HGH) Prior to Ovulation Induction for In Vitro Fertilization (IVF)
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Oocytes retrieved for IVF
研究概览
简要总结
Synthetic human growth hormone (HGH) has been available for more than a decade for specific indication in children and adults. Past Randomized Control Trials (RCT)s of HGH (under off-label use) for improving ovarian function have shown that a combination of traditional gonadotropin ovulation induction protocols, with addition of HGH is effective in increasing pregnancy rates, but not increasing egg production after IVF in women with documented diminished ovarian reserve (DOR). The investigators hypothesize that by initiating HGH at least 6 weeks prior to IVF start, the investigators will be able to increase production of oocytes and further improve pregnancy chances. This hypothesis is based on prior observations of effects of growth hormone on small antral follicles and the fact that prior studies utilized HGH principally only during ovulation induction itself.
The investigators plan to recruit 30 women (15 in each group) to an open label randomized controlled trial of HGH for augmentation of ovarian response among women with documented DOR and poor prior response to ovulation induction.
Eligible participants will be women < 45 years with documented history of prior retrieval of 2 or fewer oocytes while on maximal ovulation induction despite prior supplementation with dehydroepiandrosterone (DHEA).
Women will be treated with 1.9 mg (5.7 units) of HGH per day, beginning about 6 weeks before start of their treatment cycle. Cost of treatment with HGH will be a cost to the participating patient. HGH will cost the patient approximately $800 per week of treatment. Patients who are randomized to the non-HGH treated group, and do not conceive, will in the following cycle be offered HGH supplementation outside of this clinical trial. This subsequent cycle will not be part of the study dataset and patients will also be responsible for the cost of HGH.
Even with only 7 patients in each group, this trial will have a 99% power (error 0.05%) to detect a mean increase to 4 oocytes in the treated group. The investigators plan to recruit 15 patients in each group to allow for possible dropouts.
详细描述
Synthetic HGH was developed in 1985 and approved by the FDA for specific uses in children and adults (1996; 2003). In children, HGH injections are approved for treating short stature of unknown cause as well as poor growth due to a number of medical causes, including:
- Turner's syndrome, a genetic disorder that affects a girl's development.
- Prader-Willi syndrome, an uncommon genetic disorder causing poor muscle tone, low levels of sex hormones, and a constant feeling of hunger.
- Chronic kidney insufficiency.
- HGH deficiency or insufficiency.
- Children born small for gestational age.
In adults, approved uses of HGH include:
- Short bowel syndrome, a condition in which nutrients are not properly absorbed due to severe intestinal disease or the surgical removal of a large portion of the small intestine.
- HGH deficiency due to rare pituitary tumors or their treatment.
- Muscle-wasting disease associated with HIV/AIDS.
HGH supplementation is potentially useful in ovulation induction. Over the last decade, as recombinant HGH has become commercially available, there have been many studies looking at the effects of HGH on ovulation induction. Almost all of these studies administered HGH along with routine fertility medication during the ovulation induction cycle. Most studies used HGH doses between 4 units and 12 Units. A few studies started GH on day 21 of the previous cycle.
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 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The study will be limited to women with Poor Response to prior treatment with evidence of diminished ovarian reserve with 2 or fewer oocytes in a previous ovulation induction cycles with maximal gonadotrophin stimulation. All women in this study will be <45 years old.
排除标准
- •Cardiac disease, evidence of glucose intolerance
研究组 & 干预措施
Human Growth Hormone
1.9 mg (5.7 units) daily injection of Recombinant Human Growth Hormone (HGH) for at least 6 weeks (42 days) plus FSH 450 to 600 units per day administered subcutaneous (SQ) daily dose adjusted based on the patients response starting on day 2 of the 28 day menstrual cycle and continued until Ovulation trigger
干预措施: Human Growth Hormone (Drug)
Human Growth Hormone
1.9 mg (5.7 units) daily injection of Recombinant Human Growth Hormone (HGH) for at least 6 weeks (42 days) plus FSH 450 to 600 units per day administered subcutaneous (SQ) daily dose adjusted based on the patients response starting on day 2 of the 28 day menstrual cycle and continued until Ovulation trigger
干预措施: Follicle Stimulating Hormone (Drug)
Follicle Stimulating Hormone
FSH 450 to 600 units per day administered SQ daily dose adjusted based on the patients response starting on day 2 of the 28 day menstrual cycle and continued until Ovulation trigger
干预措施: Follicle Stimulating Hormone (Drug)
结局指标
主要结局
Oocytes retrieved for IVF
时间窗: 8 weeks after starting intervention
次要结局
- Clinical Pregnancy Rates(12 weeks after starting intervention)