Impaired fertility in men diagnosed with inflammatory arthritis: results of a large multicentre study (iFAME-Fertility)

Perez-Garcia, L. F.; Röder, Esther; Goekoop, R.J.; Hazes, Johanna M. W.; Kok, Marc R.; Smeele, H. T.; Tchetverikov, I.; Mil, Annette H M van der Helm-van; Kaap, J. H. Van der; Kok, Petra; Krijthe, Bouwe P.; Dolhain, Radboud J E M

doi:10.1136/annrheumdis-2021-220709

Cited by 19 publications

(23 citation statements)

References 47 publications

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“…A detailed description of the differences in pregnancy characteristics between the study groups is presented in Table 1 . In line with our previous findings [ 8 ], pregnancies after IA diagnosis were characterized by a statistically significant longer time to pregnancy (TTP) [6.99 ( s . d .…”

Section: Resultssupporting

confidence: 91%

“…This study is part of the iFAME-Fertility study [ 8 ]. Briefly, the iFAME-Fertility study is a multicentre cross-sectional study that was primarily designed to evaluate the impact of IA on the male fertility rate (total number of children per man).…”

Section: Methodsmentioning

confidence: 99%

“…RA, JIA, PsA and AS are frequent causes of IA that have been associated with impaired male fertility [ 7 , 8 ]. Because human reproduction failure ranges from the inability to conceive to the incapacity to maintain pregnancy after successful conception [ 9 ], it is of the utmost importance to evaluate the impact of paternal IA on pregnancy outcomes.…”

Section: Introductionmentioning

confidence: 99%

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Paternal inflammatory arthritis is associated with a higher risk of miscarriage: results of a large multicentre study (iFAME-Fertility)

et al. 2021

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Objectives Paternal preconception health is recognized as an important contributor to pregnancy outcomes. Nonetheless, pregnancy outcomes of partners of men with inflammatory arthritis (IA) have never been studied. Our objective was to describe the pregnancy outcomes of partners of men diagnosed with IA. Methods We performed a multicentre cross-sectional retrospective study conducted in the Netherlands. Men with IA who were over 40 years old that reported at least one positive pregnancy test were included. To analyze the impact of IA on pregnancy outcomes, pregnancies were classified into two groups; pregnancies conceived after the diagnosis of IA and before the diagnosis of IA. Results In total 408 male participants diagnosed with IA reported 897 singleton pregnancies that resulted in 794 live births. Pregnancies conceived after the diagnosis of IA had higher rate of miscarriage (12.27 vs 7.53%, p = <0.05). This increased risk was still present after adjusting for confounders (OR 2.03 [95%CI 1.12–3.69], p= 0.015). Conclusions This is the largest study to describe the pregnancy outcomes of partners of men diagnosed with IA and the first to demonstrate that paternal IA is associated with a higher risk of miscarriage. Notwithstanding, the overall rate of miscarriage reported in our study could be comparable to previously reported population estimates.

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Section: Resultssupporting

confidence: 91%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Paternal inflammatory arthritis is associated with a higher risk of miscarriage: results of a large multicentre study (iFAME-Fertility)

et al. 2021

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“…In men with inflammatory arthritis, the fertility rate significantly reduced with longer disease duration and also as compared to the general population. It was interesting to note that, along with reduced fertility rates, childlessness, both voluntary and involuntary, was also higher in these men, with the ones with an earlier disease onset having a higher probability of childlessness [29].…”

Section: Age and Male Fertility In Inflammatory Arthritismentioning

confidence: 98%

Testosterone and Andropause in Males With Inflammatory Arthritides

Mv¹,

Ahmed²

2022

AAEE

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Infertility is emerging as one of the leading global health concerns. The spectrum of global diseases has shifted from communicable to non-communicable, with autoimmune diseases being at the crux of it. Infertility among females with autoimmune diseases has been explored. Many inflammatory arthritides affect men in their peak reproductive and functional age. However, data on male infertility in persons having these diseases is scarce. This topical review explores the multifactorial causation of male infertility in inflammatory arthritis. These individuals tend to have gonadal dysfunction, Sertoli cell dysfunction and hypotestosteronaemia. Individuals with rheumatoid arthritis and spondyloarthritis have also reported a loss of libido owing to poor quality of life, low functional status, and erectile dysfunction. These factors along with social and psychological factors greatly influence the development of persistent sexual ill-health. Another observation is that men who have primary infertility have a higher predisposition to developing autoimmune diseases; particularly in rheumatoid arthritis and spondyloarthritis. The morbidity that comes with pain and deformities resulting from inadequately treated disease or high disease activity, can also result in poor sexual well-being. Many of the males with inflammatory arthritis tend to be voluntarily childless due to the fear of passing the disease on to their off-springs and also a possible flare when the drug therapy is modified to facilitate conception. Male fertility in autoimmune rheumatic diseases is often a neglected topic in our practice and research. Physicians must be sensitized and receptive to the issues of infertility and sexual well-being in male patients with autoimmune rheumatic diseases.

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“…Rheumatic disease can also affect sexual function and reproduction in men, with sexual dysfunction reported in a higher proportion of men with rheumatological conditions compared with healthy controls [ 12 – 14 ]. In addition, the recently conducted multicentre, cross-sectional iFAME-Fertility study found that participants diagnosed with inflammatory arthritis before and during their peak reproductive age had a lower fertility rate, a higher childlessness rate and an increased frequency of fertility problems, compared with those who were diagnosed after their peak reproductive age [ 15 ]. Importantly, some treatments for RA (and IBD) may also affect sexual and reproductive health [ 16 ].…”

Section: Rationale For Patient Selectionmentioning

confidence: 99%

MANTA and MANTA-RAy: Rationale and Design of Trials Evaluating Effects of Filgotinib on Semen Parameters in Patients with Inflammatory Diseases

Dolhain

Ritter²,

Watkins

et al. 2022

Adv Ther

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Introduction The phase 2 MANTA and MANTA-RAy studies were developed in consultation with global regulatory authorities to investigate potential impacts of filgotinib, a Janus kinase 1 preferential inhibitor, on semen parameters in men with active inflammatory diseases. Here we describe the methods and rationale for these studies. Methods and Rationale The MANTA and MANTA-RAy studies included men (aged 21–65 years) with active inflammatory bowel disease (IBD) and rheumatic diseases, respectively. Participants had no history of reproductive health issues, and the following semen parameter values (≥ 5th percentile of World Health Organization reference values) at baseline: semen volume ≥ 1.5 mL, total sperm/ejaculate ≥ 39 million, sperm concentration ≥ 15 million/mL, sperm total motility ≥ 40% and normal sperm morphology ≥ 30%. Each trial included a 13-week, randomized, double-blind, placebo-controlled period (filgotinib 200 mg vs placebo, up to N = 125 per arm), for pooled analysis of the week-13 primary endpoint (proportion of participants with ≥ 50% decrease from baseline in sperm concentration). All semen assessments were based on two samples (≤ 14 days apart) to minimize effects of physiological variation; stringent standardization processes were applied across assessment sites. From week 13, MANTA and MANTA-RAy study designs deviated owing to disease-specific considerations. All subjects with a ≥ 50% decrease in sperm parameters continued the study in the monitoring phase until reversibility, or up to a maximum of 52 weeks, with standard of care as treatment. Overall conclusions from MANTA and MANTA-RAy will be based on the totality of the data, including secondary/exploratory measures (e.g. sperm motility/morphology, sex hormones, reversibility of any effects on semen parameters). Conclusions Despite the complexities, the MANTA and MANTA-RAy studies form a robust trial programme that is the first large-scale, placebo-controlled evaluation of potential impacts of an advanced IBD and rheumatic disease therapy on semen parameters. Trial Registration EudraCT numbers 2017-000402-38 and 2018-003933-14; ClinicalTrials.gov identifiers NCT03201445 and NCT03926195. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-022-02168-4.

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Impaired fertility in men diagnosed with inflammatory arthritis: results of a large multicentre study (iFAME-Fertility)

Cited by 19 publications

References 47 publications

Paternal inflammatory arthritis is associated with a higher risk of miscarriage: results of a large multicentre study (iFAME-Fertility)

Paternal inflammatory arthritis is associated with a higher risk of miscarriage: results of a large multicentre study (iFAME-Fertility)

Testosterone and Andropause in Males With Inflammatory Arthritides

MANTA and MANTA-RAy: Rationale and Design of Trials Evaluating Effects of Filgotinib on Semen Parameters in Patients with Inflammatory Diseases

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