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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03584971
Other study ID # 18-053
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 8, 2018
Est. completion date December 30, 2021

Study information

Verified date October 2020
Source RWTH Aachen University
Contact Jan Frederik Graff, Dr.
Phone +49 241 8093341
Email Frederik.Graff@org.rwth-aachen.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study observes the effects of female cycle hormones on cooperation, competitiveness and risk preferences under experimental conditions. Especially, the causal effect of estradiol is isolated.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Patients 1. female 2. patient in fertility treatment according to Long GnRH Agonist Protocol 3. 18 years and older 4. written declaration of consent 5. persons who are contractually capable and mentally able and willing to follow the instructions of the study staff 6. understanding of the German language (written and spoken) Control group 1. male 2. 18 Years and older 3. written declaration of consent 4. persons who are contractually capable and mentally able and willing to follow the instructions of the study staff 5. understanding of the German language (written and spoken) Exclusion Criteria: Patients 1. Illiterate 2. pregnant and breastfeeding women 3. persons who are accommodated in an institution on official or court order 4. persons in a dependent or employment relationship with the auditor 5. simultaneous participation in another clinical trial Control group 1. Illiterate 2. persons who are accommodated in an institution on official or court order 3. persons in a dependent or employment relationship with the auditor 4. simultaneous participation in another clinical trial

Study Design


Related Conditions & MeSH terms

  • Behavioral Correlates of Estradiol

Locations

Country Name City State
Germany RWTH Aachen University Hospital Aachen

Sponsors (1)

Lead Sponsor Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

References & Publications (13)

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.

Drichoutis, A. C., & Nayga, R. M. (2015). Do risk and time preferences have biological roots?. Southern Economic Journal, 82(1), 235-256.

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. — View Citation

Holt, C. A., & Laury, S. K. (2002). Risk aversion and incentive effects. American economic review, 92(5), 1644-1655.

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. — View Citation

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. — View Citation

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. — View Citation

Niederle, M., & Vesterlund, L. (2007). Do women shy away from competition? Do men compete too much?. The Quarterly Journal of Economics, 1067-1101.

Pearson, M., & Schipper, B. C. (2013). Menstrual cycle and competitive bidding. Games and Economic Behavior, 78, 1-20.

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.

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.

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change of E2 [mg/l] Change of blood concentration of estradiol (E2) in mg/l Approx. 10 days after application of GnRH agonist and again approx. 14 days later
Primary Change of LH [mg/l] 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
Primary Change of Prog [mg/l] Change of blood concentration of progesterone (Prog) in mg/l Approx. 10 days after application of GnRH agonist and again approx. 14 days later
Primary Change of Cooperation 1 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
Primary Change of Competitiveness 1 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
Primary Change of Risk Preference 1 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
Primary Change of Cooperation 2 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
Primary Change of Competitiveness 2 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
Primary Change of Risk Preference 2 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