Effects of Hormonal Infertility Treatment on Cognition in Pre-Menopausal Women
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|ClinicalTrials.gov Identifier: NCT00113867|
Recruitment Status : Completed
First Posted : June 13, 2005
Last Update Posted : December 11, 2009
|Condition or disease|
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).
|Study Type :||Observational|
|Enrollment :||80 participants|
|Official Title:||Effects of Hormonal Infertility Treatment on Cognition in Pre-Menopausal Women|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||November 2006|
|Actual Study Completion Date :||November 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00113867
|United States, Maryland|
|National Institute on Aging (NIA), Harbor Hospital|
|Baltimore, Maryland, United States, 21225|
|Principal Investigator:||Melissa H. Kitner-Triolo, PhD||Research Psychologist, Laboratory of Personality & Cognition, Cognition Section, Intramural Reserach Program, National Institute on Aging, National Institutes of Health|