Documents

Participation guidelines

1. Objectives of the study

We want to determine the reasons for a decrease in couple fertility already observed in several European countries. The decrease in sperm quality over a short period of time suggests an impact of lifestyle and environmental factors rather than genetic factors. The many chemicals in our environment, including endocrine disrupters, can potentially have adverse effects on the male reproductive system. No studies to assess sperm quality have been undertaken so far in Switzerland. This is why a large-scale study including 3000 conscripts has been initiated, including the collection of epidemiological, clinical and biological data.

2. Selection of persons eligible to participate in the project

When you present yourself for military recruitment if you are male and between the ages of 18 and 22, you will be offered the opportunity to participate in the project. A complete documentation concerning the study will be sent to you. This documentation includes an information and consent form and two questionnaires, one to be completed by yourself and the other to be completed optionally by one of your parents (if possible your mother).

The march orders, as well as the study documentation, are sent to more than 97% of young people of Swiss nationality (which de facto avoids a selection bias). Exceptionally, the study may be open to other young Swiss men in the above-mentioned age group, with the prior consent of the study's logistics and clinical manager.

 

3. General information on the project

We carry out this project in compliance with the requirements of Swiss legislation. The competent cantonal ethics commissions monitored and authorised the project.

This research project aims to study a group of 3,000 unselected young volunteers throughout Switzerland via the 6 Military Recruitment Centres (Lausanne, Rüti, Windisch, Monteceneri, Sumiswald and Mels). Epidemiological, clinical and biological data are collected through questionnaires, blood, urine and semen tests. Biological analyses are carried out in a medical laboratory and samples taken are stored in a biological fluid bank (serotheque) at the University Medical Centre in Geneva for subsequent batch analyses.

A follow-up at 10 years will be carried out for the people who participated in the study. A questionnaire related to their family situation, health status and possible reproductive difficulties will be sent to them.

 

4. Procedure for participants

The study documentation will be sent to you upon military recruitment. You will then have three weeks to read the documentation and decide on your participation. There are three possible types of participation:

  • Choice 1: Participation in the biological part of the study and return of conscripted questionnaires and completed parents to the responsible physician.
  • Choice 2: Ditto without a parent questionnaire.
  • Choice 3: Return only conscript and parent questionnaires.
  • Choice 4: No interest in the study and no return of forms.

Once you have sent the consent form and questionnaire(s) back to the study logistics manager, Dr. Eric Stettler, will contact you by phone for a conversation of about ten minutes. The latter checks that you have understood the purpose of the study and possibly completes the questionnaires, if necessary. The doctor in charge remains at your disposal for any questions you may have, draws up lists which are sent to the Chief Medical Officer of the Recruitment Centres and to the biologist in charge of the analyses.

In the laboratory, you will be welcomed by a doctor who will perform a clinical examination of the urogenital system, answer any questions, take a blood sample (2 x 10 ml) and take care of the logistics of the samples. You will collect a urine sample (1 x 40 ml) and donate sperm by masturbation in a suitable space. All these operations take about 20 minutes (excluding any waiting time).

If a semen sample cannot be produced, you will be offered a participation at a later date, if you wish.

 

5. Benefits for participants

Participation in the biological study guarantees the volunteer access to the result of the sperm analysis. The consent form includes a checkbox to receive this information in writing and confidentially if you wish. In case of values below WHO standards, another checkbox allows us to communicate the results to your doctor.

Your participation in the study will be beneficial to society as it will help to define the impact of environmental factors on sperm quality in Switzerland.

By making your biological material and health data available, you are making a valuable contribution to biomedical research. We thank you for that.

 

 

6. Rights of participants

As a volunteer, you must take part in this project only according to your own will on the basis of your wish, your personal motivation and your interest. You can discuss your participation with your parents, but in the end, the decision is yours alone! If you choose not to participate or if you choose to participate and reconsider your decision during the project, you will not have to justify yourself. This will not change your usual medical care. Also your participation has no influence on the decision of your suitability for military service, your incorporation and your function. You can ask any necessary questions about the study at any time. Please contact the doctor in charge of logistics and the clinic at the end of this information sheet.

 

7. Obligations of participants

As a project participant, you will be required to:

  1. to follow the medical instructions of the project management, to allow samples to be taken under good conditions,
  2. to respect as much as possible 2 days of sexual abstinence (intercourse and/or masturbation),
  3. to note the date and time of your last ejaculation, as these will be requested when you visit the laboratory or doctor's office,
  4. in order to clarify the content of the conscript's questionnaire, we ask you to inform the doctor or biologist of any medicines and food supplements you may have taken in recent weeks.

 

8. Risks

By participating in the project, you will be exposed to minor risks related to a blood test (for example: hematoma at the blood collection level, feeling like you are passing out).

9. Discoveries during the project

If a health problem or particular risk is discovered during the study, you will be informed and the doctor in charge of the study will contact you personally to inform you and suggest the necessary steps to clarify the diagnosis and any necessary checks.

You also have the right to refuse to be informed of your results without having to justify your decision. You can also designate a third party to receive your results.

 

10. Confidentiality of data

For the purposes of the study, we will record your personal and medical data. Only the doctor in charge of the study knows your contact details. He is the only person who can establish the link between the study number (NFP50-XXXXX or NFP50-XXXXXX) assigned to you and your identity. Warning! Warning! Remember to keep the detachable part carefully at the end of the consent form. It indicates your personal study number. Take it with you on the day of recruitment. It ensures your anonymity!

All study data are only accessible through the study number. All persons involved in the study in any way whatsoever are bound by professional and medical confidentiality.

Biological fluids (identified by their code number) are stored at the Centre Médical Universitaire de Genève in a freezer at -80°C. These samples may be the subject of further studies, possibly in other research institutions.

In the case of sending data and biological samples abroad, the biological material is sent in coded form. No right of access to identification data is given to anyone. The recipient foreign institution must meet standards and requirements at least equivalent to those of the bio bank of this study in Switzerland. Compliance with national and international data protection provisions is the responsibility of the project management.

The results of this study may be published in publications that contain only grouped analyses, the presentation of which will be strictly anonymous.

You are free to refuse to allow your biological material and test results to be reused for research purposes. If you agree, you can revoke your decision at any time without having to justify yourself.

During the course of the project, inspections may be carried out. These may be carried out by the ethics commission in charge of its control. Inspections may also be mandated by the organization that initiated the project.

If you have ticked the corresponding box in the consent form, the doctor in charge of the study may contact your attending physician in the future to obtain information about your state of health. It is also expected that the doctor in charge of the study will contact you again within 10 years to find out about your family situation, your state of health, and any reproductive difficulties you may have encountered.

 

11. Withdrawal from the project

You can withdraw from the project at any time if you wish. The medical data and biological material collected so far will still be analyzed, so as not to compromise the value of the study as a whole.

However, the biological samples concerning you can be destroyed in case of withdrawal from the project if you wish.

 

12. Compensation of participants

If you participate in this project, you will not receive any remuneration for it, but you can choose either a Victorinox Swiss Army Knife or an iTunes/GOOGLE card as a thank you.

 

13. Repair of damage suffered

If you have suffered damage, you can contact the doctor in charge of the project. The costs are covered by the Military Insurance only during the days of your recruitment. No expenses will be covered if the conscript is passed to the laboratory outside of the recruitment days.

 

 

14. Project financing

The project is funded by the Swiss Centre for Applied Toxicology (SCAHT) and the Fondation privée des Hôpitaux Universitaires de Genève.

 

15. Contact person(s)

Pr. Serge Nef, Ph.D. 

Project management

Department of Genetic Medicine and Development 
University of Geneva Medical School
1, rue Michel-Servet 
CH 1211 Geneva 4, Switzerland
Phone +41 22 379 5193
email

Dr. Eric Stettler, MD

Medical and logistics manager

Lyss-Strasse 21
CH 2560 Nidau, Switzerland
Phone: +41 79 504 37 61
email

Dr. Alfred Senn, Ph.D.

Data manager and andrology specialist

Speerstrasse 6
CH 8305 Dietlikon, Switzerland

email

Rita Rahban, Ms.Sc. 

Biologist, PhD student

Department of Genetic Medicine and Development 
University of Geneva Medical School
1, rue Michel-Servet 
CH 1211 Geneva 4, Switzerland
Phone +41 22 379 5193
email