Effects of Hormonal Infertility Treatment on Cognition in Pre-Menopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to examine the effects of marked alterations in ovarian steroid hormones on cognitive functions in women. Sex hormones and stress hormones of women awaiting or undergoing in-vitro fertilization (IVF) will be compared with levels of women adopting children and women on oral contraceptives.
详细描述
Much of our understanding of the effects of ovarian steroid hormones on cognitive functioning comes from studies of changes in cognitive function associated with hormone replacement therapy (HRT) in post-menopausal women and changes in menstrual cycle phase in premenopausal women. If fluctuations in ovarian sex steroid hormone levels across the normal physiological range affect cognitive functions in women, then marked alterations in hormone levels should have a notable effect on cognitive function.
Hormonal in-vitro fertilization (IVF) treatments for female infertility result in dramatic fluctuations in estrogen levels. Women awaiting infertility treatment report negative emotions, depressed mood, declines in memory and concentration, and higher levels of reported stress compared to women who have never experienced infertility.
Four groups of twenty women each will be recruited for this observational study:
- Group 1 - IVF treatment with GnRH-a alone
- Group 2 - IVF treatment with GnRH-a plus sex steroid stimulating hormones
- Group 3 - ADPT control (women in the process of adopting children)
- Group 4 - OC (oral contraceptives) control
All groups will receive a cognitive/affect assessment twice, with a 3-week interval between assessments. Blood and salivary samples will be taken on the two test days to measure ovarian sex steroid hormone levels and stress hormone levels. Salivary samples will also be taken on a third day in between the two test days. Heart Period Variability (HPV), a measure of cardiac functioning, will be measured using electrocardiogram (ECG).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women 25 years and older, who are still ovulating
- •Residing in Maryland or the Washington DC metropolitan area
- •Healthy women in one of the following groups:
- •beginning or currently undergoing IVF infertility treatments with GnRH-a alone,
- •beginning or currently undergoing IVF infertility treatments with GnrH-a plus sex steroid stimulating hormones,
- •going through the adoption process, or
- •taking monophasic oral contraceptives for at least six months
排除标准
- •English not the primary language
- •Women who are peri- or post-menopausal
- •Women who are currently taking anti-depressants or have a history of head injury or neurological/psychiatric condition
- •Groups 1 & 2 (IVF) - women who are undergoing Inter-uterine insemination as an infertility treatment
- •Group 3 (ADPT) - women who underwent hormonal infertility treatments within the previous 6 months
- •Group 4 (OC) - women on progesterone only (mini-pill) oral contraceptives