- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03584971
Estrogen and Cooperation, Competitiveness, and Risk Preferences (FELICIA)
The Effect of Estrogen Levels on Cooperative and Competitive Decision Making and Risk Preferences
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Behavioural theories assume that, as a result of natural selection, women undergo a brief, unconscious change in some psychological aspects during ovulation. This short-term change, "ovulatory shift", is assumed to aim to increase the probability of successful reproduction in the decisive days of the female cycle. Amongst others, it is assumed that women behave particularly uncooperatively and particularly competitively towards other women during the fertile days. Though, empirical evidence is ambiguous.
The effect on risk preferences is unclear. Theory generally assumes that female risk aversion increases in the fertile days. However, empirical studies find partly positive and partly negative correlations.
Within the scope of this study, estradiol levels which are collected in the clinical treatment of patients in the Clinic for Gynaecological Endocrinology and Reproductive Medicine are to be linked with the behavioural economic measures of cooperation, competitiveness, and risk preferences, which are collected using questionnaires or a computer-based decision task.
The aim of the research project is to quasi-experimentally isolate the effect of estradiol on competitiveness, cooperation and risk preferences of women.
No study known to us has ever been able to realize a comparable quasi-experimental design which is necessary to isolate the causal effect of estradiol on different behavioural measures.
In the experimental group, a sample of approx. 50 women in fertility treatment (In Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI), long Gonadotropin releasing Hormone (GnRH) agonist protocol) is surveyed. This allows us to create a quasi-experimental design in which the estradiol level is exogenously manipulated and regularly measured.
A random sample of 30 male students of Rheinisch-Westfälische Technische Hochschule (RWTH) Aachen University serves as a control group.
We realize a longitudinal section design with measurement repetitions, which allows inter- and intrapersonal comparisons. A three-stage procedure with two measuring points and a preliminary clarification meeting is planned.
The following measuring instruments are used to record competitiveness, cooperation and risk preference: SOEP Risk Attitude, Social Value Orientation German A, The cooperative and competitive Personality Scale German, Risk aversion, Willingness to compete.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
-
-
-
Aachen, Allemagne, 52074
- Recrutement
- RWTH Aachen University Hospital
-
Contact:
- Jan Frederik Graff, Dr.
- Numéro de téléphone: +492418027066 +492418093341
- E-mail: Frederik.Graff@org.rwth-aachen.de
-
Contact:
- Benjamin Rösing, Dr.
- Numéro de téléphone: +492418027066 +492418027066
- E-mail: broesing@ukaachen.de
-
Chercheur principal:
- Benjamin Rösing
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
Patients
- female
- patient in fertility treatment according to Long GnRH Agonist Protocol
- 18 years and older
- written declaration of consent
- persons who are contractually capable and mentally able and willing to follow the instructions of the study staff
- understanding of the German language (written and spoken)
Control group
- male
- 18 Years and older
- written declaration of consent
- persons who are contractually capable and mentally able and willing to follow the instructions of the study staff
- understanding of the German language (written and spoken)
Exclusion Criteria:
Patients
- Illiterate
- pregnant and breastfeeding women
- persons who are accommodated in an institution on official or court order
- persons in a dependent or employment relationship with the auditor
- simultaneous participation in another clinical trial
Control group
- Illiterate
- persons who are accommodated in an institution on official or court order
- persons in a dependent or employment relationship with the auditor
- simultaneous participation in another clinical trial
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Autre
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
|---|
|
female patients
women in fertility treatment according to Long GnRH Agonist Protocol
|
|
control group
random sample of male students
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change of E2 [mg/l]
Délai: Approx. 10 days after application of GnRH agonist and again approx. 14 days later
|
Change of blood concentration of estradiol (E2) in mg/l
|
Approx. 10 days after application of GnRH agonist and again approx. 14 days later
|
|
Change of LH [mg/l]
Délai: Approx. 10 days after application of GnRH agonist and again approx. 14 days later
|
Change of blood concentration of the luteinizing hormone (LH) in mg/l
|
Approx. 10 days after application of GnRH agonist and again approx. 14 days later
|
|
Change of Prog [mg/l]
Délai: Approx. 10 days after application of GnRH agonist and again approx. 14 days later
|
Change of blood concentration of progesterone (Prog) in mg/l
|
Approx. 10 days after application of GnRH agonist and again approx. 14 days later
|
|
Change of Cooperation 1
Délai: Approx. 10 days after application of GnRH agonist and again approx. 14 days later
|
Change of willingness to cooperate measured via the Social Value Orientation German A (Murphy et al. 2011)
|
Approx. 10 days after application of GnRH agonist and again approx. 14 days later
|
|
Change of Competitiveness 1
Délai: Approx. 10 days after application of GnRH agonist and again approx. 14 days later
|
Change of willingness to compete measured via the cooperative and competitive Personality Scale German (Lu et al. 2006)
|
Approx. 10 days after application of GnRH agonist and again approx. 14 days later
|
|
Change of Risk Preference 1
Délai: Approx. 10 days after application of GnRH agonist and again approx. 14 days later
|
Change of Risk preferences measured via the SOEP Risk Attitude (DIW Berlin)
|
Approx. 10 days after application of GnRH agonist and again approx. 14 days later
|
|
Change of Cooperation 2
Délai: Approx. 10 days after application of GnRH agonist and again approx. 14 days later
|
Change of willingness to cooperate measured via the cooperative and competitive Personality Scale German (Lu et al. 2006)
|
Approx. 10 days after application of GnRH agonist and again approx. 14 days later
|
|
Change of Competitiveness 2
Délai: Approx. 10 days after application of GnRH agonist and again approx. 14 days later
|
Change of willingness to compete measured via the Willingness to compete measure based on Niederle & Vesterlund (2007)
|
Approx. 10 days after application of GnRH agonist and again approx. 14 days later
|
|
Change of Risk Preference 2
Délai: Approx. 10 days after application of GnRH agonist and again approx. 14 days later
|
Change of Risk preferences measured via the Risk aversion measure by Holt & Laury (2002)
|
Approx. 10 days after application of GnRH agonist and again approx. 14 days later
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Benjamin Rösing, Dr., RWTH Aachen
Publications et liens utiles
Publications générales
- Ranehill, E., Zethraeus, N., Blomberg, L., von Schoultz, B., Hirschberg, A. L., Johannesson, M., & Dreber, A. (2017). Hormonal Contraceptives Do Not Impact Economic Preferences: Evidence from a Randomized Trial. Management Science.
- Durante, K. M., Griskevicius, V., Hill, S. E., Perilloux, C., & Li, N. P. (2010). Ovulation, female competition, and product choice: Hormonal influences on consumer behavior. Journal of Consumer Research, 37(6), 921-934.
- Gangestad SW, Thornhill R. Menstrual cycle variation in women's preferences for the scent of symmetrical men. Proc Biol Sci. 1998 May 22;265(1399):927-33. doi: 10.1098/rspb.1998.0380.
- Buser, T. (2012a). Digit ratios, the menstrual cycle and social preferences. Games and Economic Behavior, 76(2), 457-470.
- Buser, T. (2012b). The impact of the menstrual cycle and hormonal contraceptives on competitiveness. Journal of Economic Behavior & Organization, 83(1), 1-10.
- Wozniak, D., Harbaugh, W. T., & Mayr, U. (2014). The menstrual cycle and performance feedback alter gender differences in competitive choices. Journal of Labor Economics, 32(1), 161-198.
- Pearson, M., & Schipper, B. C. (2013). Menstrual cycle and competitive bidding. Games and Economic Behavior, 78, 1-20.
- Drichoutis, A. C., & Nayga, R. M. (2015). Do risk and time preferences have biological roots?. Southern Economic Journal, 82(1), 235-256.
- Lazzaro SC, Rutledge RB, Burghart DR, Glimcher PW. The Impact of Menstrual Cycle Phase on Economic Choice and Rationality. PLoS One. 2016 Jan 29;11(1):e0144080. doi: 10.1371/journal.pone.0144080. eCollection 2016.
- Murphy RO, Ackermann KA. Social value orientation: theoretical and measurement issues in the study of social preferences. Pers Soc Psychol Rev. 2014 Feb;18(1):13-41. doi: 10.1177/1088868313501745. Epub 2013 Sep 23.
- Lu S, Au WT, Jiang F, Xie X, Yam P. Cooperativeness and competitiveness as two distinct constructs: validating the Cooperative and Competitive Personality Scale in a social dilemma context. Int J Psychol. 2013;48(6):1135-47. doi: 10.1080/00207594.2012.743666. Epub 2012 Nov 12.
- Holt, C. A., & Laury, S. K. (2002). Risk aversion and incentive effects. American economic review, 92(5), 1644-1655.
- Niederle, M., & Vesterlund, L. (2007). Do women shy away from competition? Do men compete too much?. The Quarterly Journal of Economics, 1067-1101.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 18-053
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .