InfertilityNCT00113867
Effects of Hormonal Infertility Treatment on Cognition in Pre-Menopausal Women
An observational study of Infertility, run by National Institute on Aging (NIA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Nov 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Aging (NIA), Harbor Hospital
Baltimore, Maryland, 21225
About this study
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.
Read the 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).
- Conditions
- Infertility
- Keywords
- IVF, in vitro fertilization, hormones, stress, memory, Cognitive Function, adoption
- Medical subject headings
- Infertility
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2005 (estimated)
- Study startSep 2003
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Melissa H. Kitner-Triolo, PhD, Principal investigator, Research Psychologist, Laboratory of Personality & Cognition, Cognition Section, Intramural Reserach Program, National Institute on Aging, National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00113867
- Sponsor's protocol ID
- AG0022
- Status last verified
- Nov 2006
- First submitted
- 10 Jun 2005
- Last updated
- 11 Dec 2009
- Results posted
- No
Publications
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.
PubMed 8675575Harlow 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.
PubMed 8671208Oddens 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.
PubMed 10374131
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hormonal Infertility Treatment on Cognition in Pre-Menopausal Women
- ClinicalTrials.gov ID
- NCT00113867
- Acronym / sponsor ID
- AG0022
- Conditions
- Infertility
- Keywords
- IVF, in vitro fertilization, hormones, stress, memory, Cognitive Function, adoption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Sep 2003
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 13 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2009.
- Background: PubMed 8675575Sherwin 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.
- Background: PubMed 8671208Harlow 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.
- Background: PubMed 10374131Oddens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa H. Kitner-Triolo, PhD principal investigator
Research Psychologist, Laboratory of Personality & Cognition, Cognition Section, Intramural Reserach Program, National Institute on Aging, National Institutes of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00113867, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2009.