Open Label, Randomized Controlled Trial, Effect of Hypnofertility on Fertility Preparedness, Cortisol Levels and Pregnancy Outcomes of Women Undergoing In Vitro Fertilization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Fertility preparedness
研究概览
简要总结
This randomized controlled study aimed to specify whether the interventions based on Hypnofertility would lead to increased fertility preparedness and pregnancy outcomes, decreased cortisol levels of women undergoing In Vitro Fertilization (IVF) treatment.
详细描述
Objective
To specify whether the interventions based on Hypnofertility would lead to increased fertility preparedness and pregnancy outcomes, decreased cortisol levels of women undergoing In Vitro Fertilization (IVF) treatment.
Design: Randomized, controlled, prospective study. Setting: University Hospital Fertility Center in Izmir. Patients: Sixty-one women with unexplained infertility undergoing IVF treatment.
Interventions: Interventions based on Hypnofertility including affirmations, visualization, dreaming and relaxation from the first day of treatment to the day of pregnancy test.
Main Outcome Measures: Fertility preparedness and cortisol levels (primary outcomes), pregnancy rate (secondary outcome).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 39 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •primary infertility,
- •unexplained infertility,
- •going to undergo IVF treatment,
- •fresh embryos,
- •under 39 years of age
- •having a smart phone
排除标准
- •participated in any program to reduce stress
- •having any psychiatric disorder
研究组 & 干预措施
Intervention
Intervention Based on Hypnofertility
干预措施: Interventions Based on Hypnofertility (Behavioral)
Control
Routine clinical procedure
干预措施: Routine clinical procedure (Other)
结局指标
主要结局
Fertility preparedness
时间窗: through study completion, average 28 days
Fertility Preparedness Scale for Women Receiving Fertility Support (FPS) The 5-point Likert scale was developed by Fata and Aluş Tokat (Fata and Aluş Tokat, 2019). This scale items consist only of positive words. The scale consists of 3 sub-dimensions: "Hope and Awareness"," Positive Feelings and Thoughts ","Prepared Body and Brain". Since the items consisted only of positive expressions, the score was calculated as they were. The scores of the items were 5 (strongly agree), 4 (agree), 3 (neutral), 2 (disagree) and 1 (strongly disagree), respectively. The minimum and maximum scores are 23 and 115, respectively. The median of the scale score is 56 points, which can be considered the cut value. If the scale score is below 56, it can be considered that the woman is not prepared for fertility. If the score is 56 and higher, it indicates greater fertility preparedness.
cortisol levels
时间窗: through study completion, average 28 days
The saliva samples were collected in sterile urine containers provided by the researcher and stored in the refrigerator at a temperature between +4 and +8 degrees for a maximum of two (2) months. On average, they were sent to the laboratory every 15 days by means of carrying bags containing ice molds. Saliva was studied by LC-MS/MS (Liquid Chromatography-Mass Spectrometry) method by the expert staff of the laboratory. Cortisol level (nmol/L) measurement was obtained for both intervention and control group in all face-to-face sessions. Because cortisol level have diurnal rythm and highest level is shown in the morning, samples were of all women in the morning once they came to clinic. Samples were to be collected with no eating, drinking, gum chewing or smoking in the 30 minutes prior to collection.
次要结局
- pregnancy rate(through study completion, average 28 days)
研究者
Sevcan Fata
Director, Clinical research
Dokuz Eylul University