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Estrogen and Cooperation, Competitiveness, and Risk Preferences (FELICIA)

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ClinicalTrials.gov Identifier: NCT03584971
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Frederik Graff, RWTH Aachen University

Brief 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.

Condition or disease
Behavioral Correlates of Estradiol

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Effect of Estrogen Levels on Cooperative and Competitive Decision Making and Risk Preferences
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Estrogens

Group/Cohort
female patients
women in fertility treatment according to Long GnRH Agonist Protocol
control group
random sample of male students



Primary Outcome Measures :
  1. Change of E2 [mg/l] [ Time Frame: Approx. 10 days after application of GnRH agonist and again approx. 14 days later ]
    Change of blood concentration of estradiol (E2) in mg/l

  2. Change of LH [mg/l] [ Time Frame: 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

  3. Change of Prog [mg/l] [ Time Frame: Approx. 10 days after application of GnRH agonist and again approx. 14 days later ]
    Change of blood concentration of progesterone (Prog) in mg/l

  4. Change of Cooperation 1 [ Time Frame: 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)

  5. Change of Competitiveness 1 [ Time Frame: 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)

  6. Change of Risk Preference 1 [ Time Frame: 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)

  7. Change of Cooperation 2 [ Time Frame: 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)

  8. Change of Competitiveness 2 [ Time Frame: 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)

  9. Change of Risk Preference 2 [ Time Frame: 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)


Biospecimen Retention:   Samples Without DNA
Estradiol via blood sample


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women in fertility treatment
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584971


Contacts
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Contact: Jan Frederik Graff, Dr. +49 241 8093341 ext +492418027066 Frederik.Graff@org.rwth-aachen.de
Contact: Benjamin Rösing, Dr. +49 241 80 27066 ext +492418027066 broesing@ukaachen.de

Locations
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Germany
RWTH Aachen University Hospital Recruiting
Aachen, Germany, 52074
Contact: Jan Frederik Graff, Dr.    +492418093341 ext +492418027066    Frederik.Graff@org.rwth-aachen.de   
Contact: Benjamin Rösing, Dr.    +492418027066 ext +492418027066    broesing@ukaachen.de   
Principal Investigator: Benjamin Rösing         
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Benjamin Rösing, Dr. RWTH Aachen

Additional Information:
Publications:
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.
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.
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.

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Responsible Party: Frederik Graff, Assistant Professor, RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03584971     History of Changes
Other Study ID Numbers: 18-053
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Frederik Graff, RWTH Aachen University:
estradiol
cooperation
competitiveness
risk preferences

Additional relevant MeSH terms:
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Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs