- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00113867
Effects of Hormonal Infertility Treatment on Cognition in Pre-Menopausal Women
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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).
Tipo di studio
Iscrizione
Contatti e Sedi
Luoghi di studio
-
-
Maryland
-
Baltimore, Maryland, Stati Uniti, 21225
- National Institute on Aging (NIA), Harbor Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Collaboratori e investigatori
Investigatori
- Investigatore principale: Melissa H. Kitner-Triolo, PhD, Research Psychologist, Laboratory of Personality & Cognition, Cognition Section, Intramural Reserach Program, National Institute on Aging, National Institutes of Health
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AG0022
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .