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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00113867
First received: June 10, 2005
Last updated: December 9, 2009
Last verified: November 2006
  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

Study Type: Observational
Official Title: Effects of Hormonal Infertility Treatment on Cognition in Pre-Menopausal Women

Resource links provided by NLM:


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

Estimated Enrollment: 80
Study Start Date: September 2003
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
ClinicalTrials.gov Identifier: NCT00113867     History of Changes
Other Study ID Numbers: AG0022
Study First Received: June 10, 2005
Last Updated: December 9, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 16, 2014