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Effects of Hormonal Infertility Treatment on Cognition in Pre-Menopausal Women

Primary Purpose

Infertility

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute on Aging (NIA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Infertility focused on measuring IVF, in vitro fertilization, hormones, stress, memory, Cognitive Function, adoption

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 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: 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: 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

Sites / Locations

  • National Institute on Aging (NIA), Harbor Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 10, 2005
Last Updated
December 9, 2009
Sponsor
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00113867
Brief Title
Effects of Hormonal Infertility Treatment on Cognition in Pre-Menopausal Women
Official Title
Effects of Hormonal Infertility Treatment on Cognition in Pre-Menopausal Women
Study Type
Observational

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Aging (NIA)

4. Oversight

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF, in vitro fertilization, hormones, stress, memory, Cognitive Function, adoption

7. Study Design

Enrollment
80 (false)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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: 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa H. Kitner-Triolo, PhD
Organizational Affiliation
Research Psychologist, Laboratory of Personality & Cognition, Cognition Section, Intramural Reserach Program, National Institute on Aging, National Institutes of Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute on Aging (NIA), Harbor Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8675575
Citation
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.
Results Reference
background
PubMed Identifier
8671208
Citation
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.
Results Reference
background
PubMed Identifier
10374131
Citation
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.
Results Reference
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Effects of Hormonal Infertility Treatment on Cognition in Pre-Menopausal Women

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