- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03584971
Estrogen and Cooperation, Competitiveness, and Risk Preferences (FELICIA)
The Effect of Estrogen Levels on Cooperative and Competitive Decision Making and Risk Preferences
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Jan Frederik Graff, Dr.
- Telefonnummer: +492418027066 +49 241 8093341
- E-post: Frederik.Graff@org.rwth-aachen.de
Studera Kontakt Backup
- Namn: Benjamin Rösing, Dr.
- Telefonnummer: +492418027066 +49 241 80 27066
- E-post: broesing@ukaachen.de
Studieorter
-
-
-
Aachen, Tyskland, 52074
- Rekrytering
- RWTH Aachen University Hospital
-
Kontakt:
- Jan Frederik Graff, Dr.
- Telefonnummer: +492418027066 +492418093341
- E-post: Frederik.Graff@org.rwth-aachen.de
-
Kontakt:
- Benjamin Rösing, Dr.
- Telefonnummer: +492418027066 +492418027066
- E-post: broesing@ukaachen.de
-
Huvudutredare:
- Benjamin Rösing
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Övrig
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
---|
female patients
women in fertility treatment according to Long GnRH Agonist Protocol
|
control group
random sample of male students
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change of E2 [mg/l]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Benjamin Rösing, Dr., RWTH Aachen
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 18-053
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .