Behavioral Correlates of EstradiolFELICIANCT03584971
Estrogen and Cooperation, Competitiveness, and Risk Preferences
An observational study of Behavioral Correlates of Estradiol, run by RWTH Aachen University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behavioral Correlates of Estradiol
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 8 Oct 2018to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women in fertility treatment
Who may be able to join
- 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
Show all 13Show fewer
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
RWTH Aachen University Hospital
Aachen, 52074
Jan Frederik Graff, Dr., +492418093341 ext. +492418027066, Frederik.Graff@org.rwth-aachen.de
Benjamin Rösing, Dr., +492418027066 ext. +492418027066, broesing@ukaachen.de
About this study
Official title: The Effect of Estrogen Levels on Cooperative and Competitive Decision Making and Risk Preferences
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.
Read the 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.
- Conditions
- Behavioral Correlates of Estradiol
- Keywords
- estradiol, cooperation, competitiveness, risk preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| female patients | women in fertility treatment according to Long GnRH Agonist Protocol | |
| control group | random sample of male students |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of E2 [mg/l]
Change of blood concentration of estradiol (E2) in mg/l
Measured: Approx. 10 days after application of GnRH agonist and again approx. 14 days later
Change of LH [mg/l]
Change of blood concentration of the luteinizing hormone (LH) in mg/l
Measured: Approx. 10 days after application of GnRH agonist and again approx. 14 days later
Change of Prog [mg/l]
Change of blood concentration of progesterone (Prog) in mg/l
Measured: Approx. 10 days after application of GnRH agonist and again approx. 14 days later
Change of Cooperation 1
Change of willingness to cooperate measured via the Social Value Orientation German A (Murphy et al. 2011)
Measured: Approx. 10 days after application of GnRH agonist and again approx. 14 days later
Change of Competitiveness 1
Change of willingness to compete measured via the cooperative and competitive Personality Scale German (Lu et al. 2006)
Measured: Approx. 10 days after application of GnRH agonist and again approx. 14 days later
Change of Risk Preference 1
Change of Risk preferences measured via the SOEP Risk Attitude (DIW Berlin)
Measured: Approx. 10 days after application of GnRH agonist and again approx. 14 days later
Change of Cooperation 2
Change of willingness to cooperate measured via the cooperative and competitive Personality Scale German (Lu et al. 2006)
Measured: Approx. 10 days after application of GnRH agonist and again approx. 14 days later
Change of Competitiveness 2
Change of willingness to compete measured via the Willingness to compete measure based on Niederle \& Vesterlund (2007)
Measured: Approx. 10 days after application of GnRH agonist and again approx. 14 days later
Change of Risk Preference 2
Change of Risk preferences measured via the Risk aversion measure by Holt \& Laury (2002)
Measured: Approx. 10 days after application of GnRH agonist and again approx. 14 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start8 Oct 2018
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Behavioral Correlates of EstradiolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederik Graff, RWTH Aachen University
- Investigators
- Benjamin Rösing, Dr., Principal investigator, RWTH Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584971
- Sponsor's protocol ID
- 18-053
- Acronym
- FELICIA
- Status last verified
- Oct 2020
- First submitted
- 21 Jun 2018
- Last updated
- 29 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
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.
PubMed 9633114Buser, 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.
PubMed 26824245Murphy 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.
PubMed 24065346Lu 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.
PubMed 23145818Holt, 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Estrogen Levels on Cooperative and Competitive Decision Making and Risk Preferences
- ClinicalTrials.gov ID
- NCT03584971
- Acronym / sponsor ID
- FELICIA / 18-053
- Conditions
- Behavioral Correlates of Estradiol
- Keywords
- estradiol, cooperation, competitiveness, risk preferences
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| female patients | – | –women in fertility treatment according to Long GnRH Agonist Protocol |
| control group | – | –random sample of male students |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women in fertility treatment
Key inclusion criteria (13 listed)
- Patients
- female
- patient in fertility treatment according to Long GnRH Agonist Protocol
- 18 years and older
- written declaration of consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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)
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)
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- BackgroundRanehill, 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.
- BackgroundDurante, 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.
- Background: PubMed 9633114Gangestad 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.
- BackgroundBuser, T. (2012a). Digit ratios, the menstrual cycle and social preferences. Games and Economic Behavior, 76(2), 457-470.
- BackgroundBuser, T. (2012b). The impact of the menstrual cycle and hormonal contraceptives on competitiveness. Journal of Economic Behavior & Organization, 83(1), 1-10.
- BackgroundWozniak, 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.
- BackgroundPearson, M., & Schipper, B. C. (2013). Menstrual cycle and competitive bidding. Games and Economic Behavior, 78, 1-20.
- BackgroundDrichoutis, A. C., & Nayga, R. M. (2015). Do risk and time preferences have biological roots?. Southern Economic Journal, 82(1), 235-256.
- Background: PubMed 26824245Lazzaro 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.
- Background: PubMed 24065346Murphy 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.
- Background: PubMed 23145818Lu 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.
- BackgroundHolt, C. A., & Laury, S. K. (2002). Risk aversion and incentive effects. American economic review, 92(5), 1644-1655.
- Website of the Deutsches Institut für Wirtschaftsforschung (DIW) Berlin with description and full questionnaires of the German Socio Economic Panel (SOEP)Link provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Rösing, Dr. principal investigator
RWTH Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behavioral Correlates of Estradiol, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Frederik Graff, Dr. (+49 241 8093341 ext. +492418027066, Frederik.Graff@org.rwth-aachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of E2 [mg/l] (time frame: Approx. 10 days after application of GnRH agonist and again approx. 14 days later). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03584971, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.