ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Effects of Hormonal Infertility Treatment on Cognition in Pre-Menopausal Women

This study has been completed.

Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00113867
  Purpose

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.


Condition
Infertility

MedlinePlus related topics:   Infertility    Menopause    Stress   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History, Longitudinal, Convenience Sample
Official Title:   Effects of Hormonal Infertility Treatment on Cognition in Pre-Menopausal Women

Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment:   80
Study Start Date:   September 2003
Estimated Study Completion Date:   December 2006

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).

  Eligibility
Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113867

Locations
United States, Maryland
National Institute on Aging (NIA), Harbor Hospital    
      Baltimore, Maryland, United States, 21225

Sponsors and Collaborators

Investigators
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    
  More Information


Publications:

Study ID Numbers:   AG0022
First Received:   June 10, 2005
Last Updated:   November 9, 2006
ClinicalTrials.gov Identifier:   NCT00113867
Health Authority:   United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
IVF  
in vitro fertilization  
hormones  
stress  
memory
Cognitive Function
adoption

Study placed in the following topic categories:
Genital Diseases, Female
Infertility
Stress
Genital Diseases, Male
Menopause

ClinicalTrials.gov processed this record on October 03, 2008




Links to all studies - primarily for crawlers