Effects of Hormonal Infertility Treatment on Cognition in Pre-Menopausal Women
1 other identifier
observational
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2003
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 10, 2005
CompletedFirst Posted
Study publicly available on registry
June 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedDecember 11, 2009
November 1, 2006
3.2 years
June 10, 2005
December 9, 2009
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute on Aging (NIA), Harbor Hospital
Baltimore, Maryland, 21225, United States
Related Publications (3)
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.
PMID: 8675575BACKGROUNDHarlow 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.
PMID: 8671208BACKGROUNDOddens 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.
PMID: 10374131BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
June 10, 2005
First Posted
June 13, 2005
Study Start
September 1, 2003
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
December 11, 2009
Record last verified: 2006-11