Men in RelationAMPlaisirNCT03459326
Sexuality of the Man Whose Couple is Taken Care of in Medical Assistance to Procreation. Study of Case Witnesses
An observational study of Men in Relation and Couple Whose Taken Care in Medical Assisted to Reproduction, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
According to the World Health Organization and the World Association for Sexual Health, sexual health is directly associated with the psychological well-being and quality of life of each individual. Infertility is a real public health problem. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Men in Relation, Couple Whose Taken Care in Medical Assisted to Reproduction
- What is being tested?
- IIEF (International Index of Erectile Function questionnaire )
- Type of treatment
- Injection or infusion
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 7 Nov 2017to 28 Feb 2019
- 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 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men in relation
Who may be able to join
- for witnesses : men in relation
- for cases : men in relation and whose couple taken care of medical assisted to procreation (IUI, FIV, ICSI)
Who cannot join
- for witnesses : single men
- for cases : men whose couple supported with gamete donation
- Men with viral risk
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 0473751195, placarin@chu-clermontferrand.fr
Stéphanie MESTRES
About this study
According to the World Health Organization and the World Association for Sexual Health, sexual health is directly associated with the psychological well-being and quality of life of each individual.
Infertility is a real public health problem. In recent years, there has been a clear decline in male fertility in industrialized countries, particularly in sperm quality. Male infertility may be perceived as a loss of masculinity and so men will be more reluctant to talk about their fertility problem than women. The studies published so far have focused on infertile men without any specification on the type or stage of care in Medically assisted procreation (MAP).
Read more
Through our work, we propose to evaluate the impact of the type of care in Medical Assistance with procreation on the sexuality of man. Does the type of MAP technique used (intrauterine insemination, in vitro fertilization or intra cytoplasmic sperm injection) have an impact on male sexuality? Sexual health and reproductive health are closely linked; management of sexual disorders is essential to improve the quality of life. A prevention of sexual difficulties during the care of these patients in MAP can be set up in the MAP service from Clermont-Ferrand hospital.
The main objective of our study is therefore to evaluate the perceived quality of sexuality by the man whose couple is engaged in a process of medical assistance to procreation.
Read the detailed description
Infertility is a real public health problem. In recent years, there has been a clear decline in male fertility in industrialized countries, particularly sperm quality. In the general population, 70% of desired pregnancies are obtained after 6 months and 90% after one year of unprotected intercourse. A couple is considered infertile in the absence of pregnancy after one year of unprotected sex. Currently about 15% of couples of childbearing age is 1 in 7 couples consult for infertility. A French team evaluated the infertility etiologies. Among 1686 couples, infertility was female in 33% of cases, male in 20% of cases and mixed in 39% of cases. Infertility was said to be unexplained in 8% of the couples evaluated.
Male partners of infertile couples experience significantly higher stress and sexual dysfunction during the fertile period compared to the non-fertile period. The high stress levels are probably due to the psychological pressure associated with efforts to conceive but certainly also with the forced moment of sexual intercourse around the ovulatory cycle of the partner. Sexuality can therefore be deprived of its recreational and erotic value and subordinated to the purpose of pregnancy. The man and the woman become "spawners" and the love relationship is organized towards a procreative goal, affecting the spontaneity of the relationship of the couple. Sexual intercourse then proceeds less and less from erotic desire and more and more desire for pregnancy. The man who doubts his fertility is ready to adjust his sexuality for greater efficiency in order to obtain the child, which represents his personal reassurance and the social proof of his sexual power. Sexual desire disorders are therefore the most frequent sexual disorder in infertile couples. Treatments and medical requirements to treat infertility may be responsible for inhibiting sexual desire. Indeed, sex becomes impersonal and driven by medical procedures. Medical assistance with procreation (MAP) is becoming increasingly important in our society. In 2011 according to the figures of the agency of biomedicine, 23 127 children were born thanks to the attempts of MPAs made, or 2.8% of children born in the general population that same year. However, MAP techniques do not always lead to pregnancy, according to the figures of the weekly epidemiological bulletin on 100 couples who start IVF:
- 41 will have a child thanks to IVF
- 59 will not have them in the context of IVF:
- 7 will have a child with another treatment
- 11 will have a child naturally
- 11 will adopt a child
- 30 couples will not have children
Infertile men may feel stigmatized because they are perceived to be deficient in a specific component of their masculinity. When men discover their infertility, men usually go through a crisis. This crisis represents a manifestation of long-standing anxiety about the nature of man, his role and function. The confusion of fertility, power and masculinity has consequences for infertile men. Male infertility can be perceived as a loss of masculinity. Men will be more reluctant to talk about their fertility problem than women. The literature suggests that the exams and the vocabulary of consultation also contribute to the anxiety of loss of male sexual identity, of self-deprecation in men. The diagnosis announcement is an important moment of care. This announcement should be cautious and the words cleverly chosen because the narcissistic injury can be profound. The team of Marci et al evaluated the impact of the diagnosis of infertility on sexuality. It could be shown that men newly diagnosed as infertile presented lower scores compared to fertile controls. This team showed that during the early stages of the diagnosis of infertility, the sexual life of couples was reached. An observational study also showed that 11% of the men had failed in the second collection because of a diagnosis of infertility. Patients in the fertile group had inferior spermatic characteristics compared with patients in the fertile group without significant difference. In the literature, a higher prevalence of erectile dysfunction in infertile men is reported compared to the general male population. The team of Khademi in 2008 show that 61.8% of patients have sexual dysfunction including 2% with severe erectile dysfunction. An observational study evaluated a total of 1,468 infertile men and 942 fertile men. The incidences of premature ejaculation (PE) and erectile dysfunction (ED) in the infertile group were significantly higher than those in the fertile group (PE: 19.01% vs. 10.93%, P <0.001; ED: 18.05% vs. 8.28%, P <0.001). In addition, anxiety and depression were more prevalent among infertile men compared to fertile men (anxiety: 38.01% vs 26.65%, p <0.001, depression: 15.74% vs. 10.08% P <0.001). Some authors reported that sexual arousal was maintained during the management of infertility. Other results have reported a decrease in sexual arousal. Despite the difficult stages they are going through, the 2 partners treated for infertility maintain a good understanding within their couple and support each other. The studies published so far have focused on infertile men without any specification on the type or stage of management of MPA. Similarly, the type of infertility encountered is rarely mentioned. Only one study assessed concordance between sperm characteristics and sexual dysfunction.
The main objective of our study is therefore to evaluate the perceived sexual quality by the man whose couple is cared for in MAP. It is an exploratory study of the control case type. This work will make it possible to evaluate the impact of the type of treatment in MAP on the sexuality of the man. Does the techniques used in MAP (Intra uterine insemination, in vitro fertilization or intra cytoplasmic sperm injection) have an impact on male sexuality? In order to be able to quantify sexual dysfunction in this study, the IIEF: the international index of erectile function questionnaire will be given to the included patients. The IIEF is an internationally validated test and translated in several languages. This questionnaire has been the subject of several publications especially in the field of infertility (Bechoua et al., 2016). It allows to assign a score of erectile dysfunction (severe score 1 to 10, moderate score 11 to 16, low to moderate score 17 to 21, low score 22 at 25, no erectile dysfunction score 26 to 30). This test also classifies sexual dysfunction under several domains.
Erectile function: item 1, 2, 3, 4, 5 and 15 (score 1 to 30) Orgasmic function: item 9 and 10 (score 0 to 10) Desire: item 11 and 12 (score 2 to 10) Sexual satisfaction: items 6, 7 and 8 (score 0 to 15) Overall satisfaction: item 13 and 14 (score 2 to 10)
Men are often left behind and may be disinvested from MAP protocols. Depending on the results, patients who have a significant impact on their sexuality of their care in MAP can be diagnosed and supported with the establishment of a sexology consultation in the service. Conducting a study of this type in the MAP service from CHU Estaing in Clermont-Ferrand will open a space of expression complementary.
- Being tested
- IIEF (International Index of Erectile Function questionnaire )
- Keywords
- male sexuality, medical assisted to procreation, International Index of Erectile Function questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IIEF (International Index of Erectile Function questionnaire )Other
The questionnaire is presented and answered without help. Answers to the IIEF Questionnaire will be collected in order to obtain the following scores (the total score is of no interest):
- Erectile function (score 1 to 30)
- Orgasmic function (score 0 to 10)
- Desire (score 2 to 10)
- Sexual satisfaction (score 0 to 15)
- Overall satisfaction (score 2 to 10)
| Study group | Role | What they receive |
|---|---|---|
| control group | men in relation Receives: Other: IIEF (International Index of Erectile Function questionnaire ) | |
| FIV group | men whose couple taken care of fecundation in vitro Receives: Other: IIEF (International Index of Erectile Function questionnaire ) | |
| ICSI group | men whose couple taken care of intracytoplasmic injection Receives: Other: IIEF (International Index of Erectile Function questionnaire ) | |
| IUI group | men whose couple taken care of intrauterine insemination Receives: Other: IIEF (International Index of Erectile Function questionnaire ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of sexual quality by man
In order to quantify sexual dysfunction, the International Index of Erectile Function questionnaire (IIEF) will be given to patients included. The IIEF is an internationally validated test. It is used to assign a score of erectile dysfunction: severe score 1 to 10; moderate score 11 to 16; low to moderate score 17 to 21; Low score 22 to 25; no erectile dysfunction score 26 to 30
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start7 Nov 2017
- Primary completion28 Feb 2019 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Men in RelationStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie MESTRES, MD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459326
- Sponsor's protocol ID
- CHU-383
- Other IDs
- 2017-A00902-51
- Acronym
- AMPlaisir
- Status last verified
- Feb 2019
- First submitted
- 2 Mar 2018
- Last updated
- 4 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexuality of the Man Whose Couple is Taken Care of in Medical Assistance to Procreation. Study of Case Witnesses
- ClinicalTrials.gov ID
- NCT03459326
- Acronym / sponsor ID
- AMPlaisir / CHU-383
- Keywords
- male sexuality, medical assisted to procreation, International Index of Erectile Function questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 8 Mar 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.
According to the World Health Organization and the World Association for Sexual Health, sexual health is directly associated with the psychological well-being and quality of life of each individual.
Infertility is a real public health problem. In recent years, there has been a clear decline in male fertility in industrialized countries, particularly in sperm quality. Male infertility may be perceived as a loss of masculinity and so men will be more reluctant to talk about their fertility problem than women. The studies published so far have focused on infertile men without any specification on the type or stage of care in Medically assisted procreation (MAP).
Through our work, we propose to evaluate the impact of the type of care in Medical Assistance with procreation on the sexuality of man. Does the type of MAP technique used (intrauterine insemination, in vitro fertilization or intra cytoplasmic sperm injection) have an impact on male sexuality? Sexual health and reproductive health are closely linked; management of sexual disorders is essential to improve the quality of life. A prevention of sexual difficulties during the care of these patients in MAP can be set up in the MAP service from Clermont-Ferrand hospital.
The main objective of our study is therefore to evaluate the perceived quality of sexuality by the man whose couple is engaged in a process of medical assistance to procreation.
Detailed description
Infertility is a real public health problem. In recent years, there has been a clear decline in male fertility in industrialized countries, particularly sperm quality. In the general population, 70% of desired pregnancies are obtained after 6 months and 90% after one year of unprotected intercourse. A couple is considered infertile in the absence of pregnancy after one year of unprotected sex. Currently about 15% of couples of childbearing age is 1 in 7 couples consult for infertility. A French team evaluated the infertility etiologies. Among 1686 couples, infertility was female in 33% of cases, male in 20% of cases and mixed in 39% of cases. Infertility was said to be unexplained in 8% of the couples evaluated.
Male partners of infertile couples experience significantly higher stress and sexual dysfunction during the fertile period compared to the non-fertile period. The high stress levels are probably due to the psychological pressure associated with efforts to conceive but certainly also with the forced moment of sexual intercourse around the ovulatory cycle of the partner. Sexuality can therefore be deprived of its recreational and erotic value and subordinated to the purpose of pregnancy. The man and the woman become "spawners" and the love relationship is organized towards a procreative goal, affecting the spontaneity of the relationship of the couple. Sexual intercourse then proceeds less and less from erotic desire and more and more desire for pregnancy. The man who doubts his fertility is ready to adjust his sexuality for greater efficiency in order to obtain the child, which represents his personal reassurance and the social proof of his sexual power. Sexual desire disorders are therefore the most frequent sexual disorder in infertile couples. Treatments and medical requirements to treat infertility may be responsible for inhibiting sexual desire. Indeed, sex becomes impersonal and driven by medical procedures. Medical assistance with procreation (MAP) is becoming increasingly important in our society. In 2011 according to the figures of the agency of biomedicine, 23 127 children were born thanks to the attempts of MPAs made, or 2.8% of children born in the general population that same year. However, MAP techniques do not always lead to pregnancy, according to the figures of the weekly epidemiological bulletin on 100 couples who start IVF:
- 41 will have a child thanks to IVF
- 59 will not have them in the context of IVF:
- 7 will have a child with another treatment
- 11 will have a child naturally
- 11 will adopt a child
- 30 couples will not have children
Infertile men may feel stigmatized because they are perceived to be deficient in a specific component of their masculinity. When men discover their infertility, men usually go through a crisis. This crisis represents a manifestation of long-standing anxiety about the nature of man, his role and function. The confusion of fertility, power and masculinity has consequences for infertile men. Male infertility can be perceived as a loss of masculinity. Men will be more reluctant to talk about their fertility problem than women. The literature suggests that the exams and the vocabulary of consultation also contribute to the anxiety of loss of male sexual identity, of self-deprecation in men. The diagnosis announcement is an important moment of care. This announcement should be cautious and the words cleverly chosen because the narcissistic injury can be profound. The team of Marci et al evaluated the impact of the diagnosis of infertility on sexuality. It could be shown that men newly diagnosed as infertile presented lower scores compared to fertile controls. This team showed that during the early stages of the diagnosis of infertility, the sexual life of couples was reached. An observational study also showed that 11% of the men had failed in the second collection because of a diagnosis of infertility. Patients in the fertile group had inferior spermatic characteristics compared with patients in the fertile group without significant difference. In the literature, a higher prevalence of erectile dysfunction in infertile men is reported compared to the general male population. The team of Khademi in 2008 show that 61.8% of patients have sexual dysfunction including 2% with severe erectile dysfunction. An observational study evaluated a total of 1,468 infertile men and 942 fertile men. The incidences of premature ejaculation (PE) and erectile dysfunction (ED) in the infertile group were significantly higher than those in the fertile group (PE: 19.01% vs. 10.93%, P <0.001; ED: 18.05% vs. 8.28%, P <0.001). In addition, anxiety and depression were more prevalent among infertile men compared to fertile men (anxiety: 38.01% vs 26.65%, p <0.001, depression: 15.74% vs. 10.08% P <0.001). Some authors reported that sexual arousal was maintained during the management of infertility. Other results have reported a decrease in sexual arousal. Despite the difficult stages they are going through, the 2 partners treated for infertility maintain a good understanding within their couple and support each other. The studies published so far have focused on infertile men without any specification on the type or stage of management of MPA. Similarly, the type of infertility encountered is rarely mentioned. Only one study assessed concordance between sperm characteristics and sexual dysfunction.
The main objective of our study is therefore to evaluate the perceived sexual quality by the man whose couple is cared for in MAP. It is an exploratory study of the control case type. This work will make it possible to evaluate the impact of the type of treatment in MAP on the sexuality of the man. Does the techniques used in MAP (Intra uterine insemination, in vitro fertilization or intra cytoplasmic sperm injection) have an impact on male sexuality? In order to be able to quantify sexual dysfunction in this study, the IIEF: the international index of erectile function questionnaire will be given to the included patients. The IIEF is an internationally validated test and translated in several languages. This questionnaire has been the subject of several publications especially in the field of infertility (Bechoua et al., 2016). It allows to assign a score of erectile dysfunction (severe score 1 to 10, moderate score 11 to 16, low to moderate score 17 to 21, low score 22 at 25, no erectile dysfunction score 26 to 30). This test also classifies sexual dysfunction under several domains.
Erectile function: item 1, 2, 3, 4, 5 and 15 (score 1 to 30) Orgasmic function: item 9 and 10 (score 0 to 10) Desire: item 11 and 12 (score 2 to 10) Sexual satisfaction: items 6, 7 and 8 (score 0 to 15) Overall satisfaction: item 13 and 14 (score 2 to 10)
Men are often left behind and may be disinvested from MAP protocols. Depending on the results, patients who have a significant impact on their sexuality of their care in MAP can be diagnosed and supported with the establishment of a sexology consultation in the service. Conducting a study of this type in the MAP service from CHU Estaing in Clermont-Ferrand will open a space of expression complementary.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | – | Other: IIEF (International Index of Erectile Function questionnaire )men in relation |
| FIV group | – | Other: IIEF (International Index of Erectile Function questionnaire )men whose couple taken care of fecundation in vitro |
| ICSI group | – | Other: IIEF (International Index of Erectile Function questionnaire )men whose couple taken care of intracytoplasmic injection |
| IUI group | – | Other: IIEF (International Index of Erectile Function questionnaire )men whose couple taken care of intrauterine insemination |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men in relation
Key inclusion criteria (2 listed)
- for witnesses : men in relation
- for cases : men in relation and whose couple taken care of medical assisted to procreation (IUI, FIV, ICSI)
Key exclusion criteria (3 listed)
- for witnesses : single men
- for cases : men whose couple supported with gamete donation
- Men with viral risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IIEF (International Index of Erectile Function questionnaire )The questionnaire is presented and answered without help. Answers to the IIEF Questionnaire will be collected in order to obtain the following scores (the total score is of no interest): * Erectile function (score 1 to 30) * Orgasmic function (score 0 to 10) * Desire (score 2 to 10) * Sexual satisfaction (score 0 to 15) * Overall satisfaction (score 2 to 10) | Other | FIV group, ICSI group, IUI group, control group |
Primary outcome
Perception of sexual quality by man
Time frame: at day 1
In order to quantify sexual dysfunction, the International Index of Erectile Function questionnaire (IIEF) will be given to patients included. The IIEF is an internationally validated test. It is used to assign a score of erectile dysfunction: severe score 1 to 10; moderate score 11 to 16; low to moderate score 17 to 21; Low score 22 to 25; no erectile dysfunction score 26 to 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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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.
Stéphanie MESTRES, MD principal investigator
University Hospital, Clermont-Ferrand
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 Men in Relation and Couple Whose Taken Care in Medical Assisted to Reproduction, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 2 inclusion and 3 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 4 Feb 2019. 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 France. 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 Patrick LACARIN (0473751195, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of sexual quality by man (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2019.