Patient's Preferences About Subcutaneous or Vaginal Progesterone Administration for Luteal Phase Support: Prospective Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Grade of use satisfaction reported by the patients
研究概览
简要总结
Luteal phase support in "in vitro fertilization" (IVF) cycles has been shown to improve pregnancy rates and became a standard of treatment, and progesterone is the first choice considering its safety profile and effectiveness. There are many studies demonstrating that vaginal progesterone is equally efficacious and better tolerated compared to intramuscular progesterone for luteal phase support in IVF cycles. Conversely, although different studies showed that subcutaneous progesterone is equally efficacious compared to vaginal progesterone, patient use satisfaction and compliance were less studied with few evidences are available, that may guide the choice of vaginal progesterone instead of subcutaneous progesterone and other way around. Considering the paucity of published data about the patient's preference and use satisfaction about subcutaneous progesterone, the investigators will conduct a prospective randomized study aimed to compared adverse effects rates, impact on quality of life, use satisfaction and administration preference in women undergoing luteal phase support with vaginal progesterone versus subcutaneous progesterone during IVF cycles, that may guide the choice for luteal phase support in IVF cycles.
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 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Infertile women candidate to undergo fresh IVF cycles
排除标准
- •day-3 follicle-stimulating hormone (FSH) levels over 15 IU/L
- •clinically relevant systemic disease (e.g., uncontrolled thyroid and adrenal dysfunction, an organic intracranial lesion such as a pituitary tumor, insulin-dependent diabetes mellitus, cancers)
- •hypersensitivity to any of the study drugs
- •contraindications to use the study drugs
- •surgical or medical condition that would interfere with absorption, distribution, metabolism, or excretion of the study drugs
研究组 & 干预措施
Subcutaneous progesterone
After standard stimulating protocol for IVF, beginning on the day of oocyte retrieval allocated patients receive subcutaneous progesterone (Pleyris, IBSA Farmaceutici, Italia) 25 mg one time per day (every day at the same time, according to patient's availability and preference) for at least 8 gestational weeks or confirmation of a negative pregnancy test performed 14 days after oocyte retrieval.
干预措施: Subcutaneous Progesterone (Drug)
Vaginal progesterone
After standard stimulating protocol for IVF, beginning on the day of oocyte retrieval allocated patients receive micronized vaginal progesterone (Progeffik, EFFIK Spa, Italia) 200 mg three times per day (every 8 hours) for at least 8 gestational weeks or confirmation of a negative pregnancy test performed 14 days after oocyte retrieval.
干预措施: Vaginal progesterone (Drug)
结局指标
主要结局
Grade of use satisfaction reported by the patients
时间窗: At the human chorionic gonadotropin test performed after 14 days of progesterone use
Patients will be asked how satisfied they are by the use of progesterone product that they receive in the luteal phase. Their satisfaction responses will be recorded on a scale of 1 to 3, with 1 being ''least satisfied'' and 3 being ''most satisfied'.
Grade of quality of life impairment reported by the patients
时间窗: At the human chorionic gonadotropin test performed after 14 days of progesterone use
Patients will be asked whether work life, social life, sexual life, and personal hygiene are perceived impaired by the progesterone treatment that they received. The answer for each item is "yes" or "no".
Adverse effects (AEs)
时间窗: At the human chorionic gonadotropin test performed after 14 days of progesterone use
Patients will be asked to report experienced AEs. The investigated AEs are sleepiness, dizziness, headache, bowel dysfunctions, breast pain/tension, weight changes, mood disorders, skin irritation, and vaginal discharge. The answer for each item is "yes" or "no".
次要结局
- Progesterone administration route that the patients prefer(At the human chorionic gonadotropin test performed after 14 days of progesterone use)
- Implantation rate(At the human chorionic gonadotropin test performed after 14 days of progesterone use)
- Clinically pregnancy rate(At 6 week from oocyte retrieval)
- live birth rate(At nine months from oocyte retrieval)
研究者
Simone Garzon
Principal Investigator
Universita di Verona