Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113867
Status:
COMPLETED
Last Update Posted:
2009-12-11
First Post:
2005-06-10
Brief Title:
Effects of Hormonal Infertility Treatment on Cognition in Pre-Menopausal Women
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Effects of Hormonal Infertility Treatment on Cognition in Pre-Menopausal Women
Status:
COMPLETED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 cognitiveaffect 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
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 cognitiveaffect 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None