Effects of Hormonal Infertility Treatment on Cognition in Pre-Menopausal Women
NCT ID: NCT00113867
Last Updated: 2009-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2003-09-30
2006-11-30
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Eligibility Criteria
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Inclusion Criteria
* Residing in Maryland or the Washington DC metropolitan area
* Healthy women in one of the following groups:
* 1\) beginning or currently undergoing IVF infertility treatments with GnRH-a alone,
* 2\) beginning or currently undergoing IVF infertility treatments with GnrH-a plus sex steroid stimulating hormones,
* 3\) going through the adoption process, or
* 4\) taking monophasic oral contraceptives for at least six months
Exclusion Criteria
* 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
25 Years
FEMALE
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Principal Investigators
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Melissa H. Kitner-Triolo, PhD
Role: PRINCIPAL_INVESTIGATOR
Research Psychologist, Laboratory of Personality & Cognition, Cognition Section, Intramural Reserach Program, National Institute on Aging, National Institutes of Health
Locations
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National Institute on Aging (NIA), Harbor Hospital
Baltimore, Maryland, United States
Countries
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References
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Sherwin BB, Tulandi T. "Add-back" estrogen reverses cognitive deficits induced by a gonadotropin-releasing hormone agonist in women with leiomyomata uteri. J Clin Endocrinol Metab. 1996 Jul;81(7):2545-9. doi: 10.1210/jcem.81.7.8675575.
Harlow CR, Fahy UM, Talbot WM, Wardle PG, Hull MG. Stress and stress-related hormones during in-vitro fertilization treatment. Hum Reprod. 1996 Feb;11(2):274-9. doi: 10.1093/humrep/11.2.274.
Oddens BJ, den Tonkelaar I, Nieuwenhuyse H. Psychosocial experiences in women facing fertility problems--a comparative survey. Hum Reprod. 1999 Jan;14(1):255-61. doi: 10.1093/humrep/14.1.255.
Other Identifiers
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AG0022
Identifier Type: -
Identifier Source: org_study_id