Parenthood Rates in 1735 Couples: Impact of Male Infertility
Parenthood Rates in 1735 Couples: Impact of Male Infertility
In 2008, we performed a retrospective cohort study including all men consulting for male infertility between January 2000 and December 2004 at the Toulouse Male Sterility Centre (TMSC), Paule de Viguier University Hospital, Toulouse, France. Males were mainly referred to TMSC by a gynaecologist after evaluation of the female partner and/or an abnormal semen evaluation. Male infertility was defined as the inability of the couple to conceive after 12 months of contraceptive-free intercourse in the absence of female factors. Couples were included if we could verify that any identified causes of female infertility (tubal disorders, ovulation disorders, cervical disorders, endometriosis and hormonal disorders) had been treated at the date of inclusion.
Couples were followed at entry and during treatment by a specialist andrologist until either discontinuation of treatment or delivery of a live infant (duration of follow-up ranged between 4 and 9 years after the date of inclusion). The outcome assessment was based not only on delivery of a live infant obtained at TMSC but also on delivery of a live infant obtained at other ART centres after discontinuation at TMSC, as well as natural pregnancies and adoptions. The study received approval from the French Data Protection Authority in 2007 (N°07-290).
In the first semester of 2008, a letter describing the study was sent to all the men who had consulted for infertility in our centre from 2000 through 2004, asking them to participate in the study by agreeing to a telephone interview. Short telephone interviews with the respondents were then conducted by trained interviewers. The interview covered male and female sociodemographic information relating to both partners, type of treatment and outcomes after discontinuation of treatment at TMSC, and final achievement or otherwise of their wish to have a child (including adoption). In the case of patients to whom the descriptive letter had not been delivered (patients who were 'not known' at the address they had given and letters that were returned to our research centre), we used the regional or national phone directory to contact them directly. Patients from whom no formal consent or refusal of consent was received after 2 months were recontacted by telephone and then by mail.
In a second step, the medical records of all respondents were analysed to obtain precise information on the main cause of infertility, type of treatments and reproductive outcomes. The grade of male infertility disorder was established from basic semen parameters, concentration and progressive motility according to the WHO criteria (World Health Organization, 2010). Only men who provided a semen sample at TMSC were included in order to avoid inter-laboratory variability. Semen samples were collected by masturbation after a recommended 3–5 days of sexual abstinence. Semen analyses were performed according to the WHO recommendations.
Four grades were defined:
At the TMSC, non-ART treatments (both medical and surgical, including pharmacological and hormonal treatment, varicocelectomy and vas deferens/epididymis surgery) could be proposed to infertile couples in the first instance. In addition, infertile couples, according to the grade of their infertility, could be offered six IUI and/or four IVF or ICSI treatment cycles using the partner's sperm and/or IUI/IVF with donor sperm. Treatments of infertility were classified according to the last recorded treatment as ART treatments (IUI, IVF, ICSI using male sperm cells and ART with donor sperm) and non-ART treatments. Reproductive outcomes were classified as pregnancies through ART, pregnancies through non-ART treatments and natural pregnancies (i.e. without any treatment).
Data were first compared for respondents, those who refused to respond and non-respondents using the χ test and Fisher's exact test. Logistic regression was performed to describe factors associated with successful or unsuccessful parenthood outcome using crude and adjusted odds ratio (OR) and 95% confidence intervals (CIs).
The cumulative proportions of successful outcomes were calculated for the period studied after ART treatments (IUI, IVF, ICSI using male semen and ART with sperm donor), non-ART treatments and natural pregnancy were taken into account, using cumulative frequencies.
The Kaplan–Meier method was used to estimate the cumulative rates of successful parenthood outcomes and 95% CI. Censors were defined as couples who did not succeed in becoming parents. As information on reproductive outcome was not available for all men who had consulted for infertility (i.e. no information was obtained through various medical records for some patients who refused to respond and non-respondents), cumulative success rates were calculated according to two hypotheses. The 'optimistic' hypothesis assumes that patients for whom no information was available have the same chance of success in having a child as patients whose reproductive outcome was known. Therefore, we present the 'pessimistic' cumulative success rates calculated according to the assumption that none of the patients for whom no reproductive information was available succeeded in having a child.
Statistical analysis was performed using SAS software (9.0, SAS Institute, Inc.) and the significance level was defined as 5%.
Materials and Methods
Patients
In 2008, we performed a retrospective cohort study including all men consulting for male infertility between January 2000 and December 2004 at the Toulouse Male Sterility Centre (TMSC), Paule de Viguier University Hospital, Toulouse, France. Males were mainly referred to TMSC by a gynaecologist after evaluation of the female partner and/or an abnormal semen evaluation. Male infertility was defined as the inability of the couple to conceive after 12 months of contraceptive-free intercourse in the absence of female factors. Couples were included if we could verify that any identified causes of female infertility (tubal disorders, ovulation disorders, cervical disorders, endometriosis and hormonal disorders) had been treated at the date of inclusion.
Couples were followed at entry and during treatment by a specialist andrologist until either discontinuation of treatment or delivery of a live infant (duration of follow-up ranged between 4 and 9 years after the date of inclusion). The outcome assessment was based not only on delivery of a live infant obtained at TMSC but also on delivery of a live infant obtained at other ART centres after discontinuation at TMSC, as well as natural pregnancies and adoptions. The study received approval from the French Data Protection Authority in 2007 (N°07-290).
Data Collection
In the first semester of 2008, a letter describing the study was sent to all the men who had consulted for infertility in our centre from 2000 through 2004, asking them to participate in the study by agreeing to a telephone interview. Short telephone interviews with the respondents were then conducted by trained interviewers. The interview covered male and female sociodemographic information relating to both partners, type of treatment and outcomes after discontinuation of treatment at TMSC, and final achievement or otherwise of their wish to have a child (including adoption). In the case of patients to whom the descriptive letter had not been delivered (patients who were 'not known' at the address they had given and letters that were returned to our research centre), we used the regional or national phone directory to contact them directly. Patients from whom no formal consent or refusal of consent was received after 2 months were recontacted by telephone and then by mail.
In a second step, the medical records of all respondents were analysed to obtain precise information on the main cause of infertility, type of treatments and reproductive outcomes. The grade of male infertility disorder was established from basic semen parameters, concentration and progressive motility according to the WHO criteria (World Health Organization, 2010). Only men who provided a semen sample at TMSC were included in order to avoid inter-laboratory variability. Semen samples were collected by masturbation after a recommended 3–5 days of sexual abstinence. Semen analyses were performed according to the WHO recommendations.
Four grades were defined:
no identified semen factor: concentration ≥15 × 10 spz/ml and motility ≥32%;
mild semen factor: concentration ≥5 × 10 and <15 × 10 spz/ml and motility ≥20% or concentration ≥15 × 10 spz/ml and motility ≥20 and <32%;
severe semen factor: concentration >0 and <5 × 10 spz/ml or motility >0 and <20%;
semen sterility: concentration = 0 or motility = 0.
At the TMSC, non-ART treatments (both medical and surgical, including pharmacological and hormonal treatment, varicocelectomy and vas deferens/epididymis surgery) could be proposed to infertile couples in the first instance. In addition, infertile couples, according to the grade of their infertility, could be offered six IUI and/or four IVF or ICSI treatment cycles using the partner's sperm and/or IUI/IVF with donor sperm. Treatments of infertility were classified according to the last recorded treatment as ART treatments (IUI, IVF, ICSI using male sperm cells and ART with donor sperm) and non-ART treatments. Reproductive outcomes were classified as pregnancies through ART, pregnancies through non-ART treatments and natural pregnancies (i.e. without any treatment).
Statistical Analysis
Data were first compared for respondents, those who refused to respond and non-respondents using the χ test and Fisher's exact test. Logistic regression was performed to describe factors associated with successful or unsuccessful parenthood outcome using crude and adjusted odds ratio (OR) and 95% confidence intervals (CIs).
The cumulative proportions of successful outcomes were calculated for the period studied after ART treatments (IUI, IVF, ICSI using male semen and ART with sperm donor), non-ART treatments and natural pregnancy were taken into account, using cumulative frequencies.
The Kaplan–Meier method was used to estimate the cumulative rates of successful parenthood outcomes and 95% CI. Censors were defined as couples who did not succeed in becoming parents. As information on reproductive outcome was not available for all men who had consulted for infertility (i.e. no information was obtained through various medical records for some patients who refused to respond and non-respondents), cumulative success rates were calculated according to two hypotheses. The 'optimistic' hypothesis assumes that patients for whom no information was available have the same chance of success in having a child as patients whose reproductive outcome was known. Therefore, we present the 'pessimistic' cumulative success rates calculated according to the assumption that none of the patients for whom no reproductive information was available succeeded in having a child.
Statistical analysis was performed using SAS software (9.0, SAS Institute, Inc.) and the significance level was defined as 5%.
