Injection Free Natural Cycle In Vitro Fertilisation by Using a Nasal GnRH Agonist to Induce Ovulation. Is it More Comfortable for Patients and Equally Effective as Subcutaneous hCG Injection?
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 112
- 主要终点
- Treatment tolerability
研究概览
简要总结
Investigation of Natural Cycle In vitro Fertilisation (NC-IVF) treatment with ovulation induction with a nasal GnRH agonist instead of regular NC-IVF treatment with subcutaneous application of hCG with the objective of increasing treatment tolerability and reducing discomfort while being equally successful in terms of embryo transfer rates.
详细描述
In vitro Fertilisation (IVF) treatments can be performed without gonadotropins to reduce side effects. These kinds of IVF treatments are called Natural Cycle IVF (NC-IVF). As NC-IVFs are almost equally effective as classical IVF with gonadotropins but less stressful, they are preferred by many women.
However, a relevant burden in NC-IVF still is the ovulation induction by self-injection of human Chorionic Gonadotropin (hCG).
Replacing hCG injection by a nasally applicable Gonadotropin-Releasing Hormone agonist (GnRHa) might reduce this discomfort. GnRHa are already used to induce ovulation in classical IVF treatments.
The objective of our study ist to answer the question whether NC-IVF treatment with a nasal GnRH agonist can increase treatment tolerability and reduce discomfort while being equally successful in terms of embryo transfer rates than NC-IVF treatment with subcutaneous application of hCG.
The study will be a randomized controlled proof-of-concept trial. It will be performed in two steps whereas the power analysis only relates to the first step which is prospective-randomized and will be performed as follows:
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 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Indication for IVF
- •Wish to perform NC-IVF
- •Regular menstruation cycles (26-32 days)
- •Orthotopic localization of ovaries
- •Age 18-42
- •Written informed consent
排除标准
- •Endometrioses III°-IV°
- •≥ 3 embryo transfers in previous IVF therapies without pregnancy
- •Contraindications or allergies against study medications
- •< 18 and > 42 years of age
- •Known or suspected non-compliance
- •Inability of the participant to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
- •Participation in another study with investigational drug within the 30 days preceding and during the present study
- •Previous enrolment into the current study
- •Enrolment of the investigators, their family members, employees and other dependent persons
研究组 & 干预措施
Intervention A: hCG injection
Ovulation induction by subcutaneous injection of 5.000 IU hCG
干预措施: hCG Injection (Drug)
Intervention B: nasal application of Nafarelin
Ovulation induction by nasal application of 200 microgram Nafarelin
干预措施: Nafarelin nasal spray (Drug)
结局指标
主要结局
Treatment tolerability
时间窗: It will be assessed between Ovulation induction and follicle aspiration. It takes about 3 minutes to complete in the questionnaire
Treatment tolerability will be measured with the Treatment tolerability subscale of the Fertility Quality of Life (FertiQoL) Treatment questionnaire. The subscale assesses the experience of mental and physical symptoms and disruption in daily life due to treatment. It consists of 4 items. Each item has a set of 5 possible responses, from which patients have to chose the one that most closely reflects how they think and feel.
Discomfort of treatment
时间窗: It will be assessed between Ovulation induction and follicle aspiration. It takes about 2 minutes to complete in the questionnaire
The level of discomfort of the treatment encountered by the patients will be measured with 3 Visual Analogue Scale (VAS) questions ranging from 1 - 10 to specifically compare the discomfort imposed by the two treatments.
次要结局
- Embryo transfer rate(It will be documented after the embryo transfer (2-5 days after follicle aspiration))