For many couples, infertility is a disease. The cause can be male factor such as a low sperm count or can be due to female factors such as blocked fallopian tubes, ovulatory disorders, or uterine abnormalities. In approximately 20 percent of cases, the cause of the infertility is unexplained. Historically, lack of conception beyond a certain length of time in couples who engage in heterosexual intercourse was the frame of reference by which infertility was defined. However, this definition fails to acknowledge the reproductive interests of a broad swath of humanity. Populations not represented in the 'traditional' definition of infertility include single individuals, those in same-sex relationships, and transgender people whose transition has affected their ability to conceive through intercourse.
Given the lack of inclusivity of the historical disease-based definition of infertility, the American Society for Reproductive Medicine (ASRM) sought to expand it to underscore the importance of family building as a basic human right in 2023. This follows previous international attempts in support of family building. For example, the United Nations, in its 1948 Universal Declaration of Human Rights, stated that 'Men and women of full age, without any limitation due to race, nationality or religion, have the right to marry and to found a family'. The United Nations definition, written three-quarters of a century ago, was an important milestone for the time and a valiant attempt to establish the critical value of and human right to create a family. However, it fails to acknowledge 1) the reality that marriage is not a prerequisite for founding a family, and 2) that men and women are not the prerequisite unit for the creation and maintenance of family building. In the modern era, efforts to expand these protections are underway, and ASRM has as one of its missions to broaden access to care. Its new definition of infertility plays an important role in furthering this goal.
While criteria for infertility based on the duration of time during which conception is attempted still apply to heterosexual couples, a more nuanced approach is required to accommodate individuals and couples who are not served by a time-based definition. ASRM's new definition seeks to remedy this situation by expanding the definition of infertility beyond a disease, as follows:
'Infertility' is a disease, condition, or status characterised by any of the following:
- The inability to achieve a successful pregnancy based on a patient's medical, sexual, and reproductive history, age, physical findings, diagnostic testing, or any combination of those factors.
- The need for medical intervention, including, but not limited to, the use of donor gametes or donor embryos in order to achieve a successful pregnancy either as an individual or with a partner.
- In patients having regular, unprotected intercourse and without any known diagnosis for either partner suggestive of impaired reproductive ability, evaluation should be initiated at 12 months when the female partner is under 35 years of age and at six months when the female partner is 35 years of age or older.
Nothing in this definition shall be used to deny or delay treatment to any individual, regardless of relationship status or sexual orientation.
As an example, being in a same-sex relationship is a condition under which it is not possible to reproduce without assistance from a third party. The new definition of infertility acknowledges this and specifically references the use of donor egg, donor sperm and donor embryos as a means for achieving a successful pregnancy. Similarly, individuals whose current status is that of being single need to avail themselves of donor gametes or embryos in order to conceive, as do those whose gender identity may prevent them from gestating a pregnancy as it risks causing gender dysphoria.
In keeping with the need to provide guidance to direct the provision of assisted reproductive care to heterosexual couples, ASRM has reaffirmed its long-standing time-based definition of infertility based on age. For women under 35 years of age without a known condition that may affect conception, fertility care should be sought out after one year of unprotected intercourse. For women 35 years of age or older, it is appropriate to initiate a fertility evaluation after six months of unprotected intercourse. This expedited time to begin a fertility evaluation and promptly consider treatment in women beyond the age of 35 is supported by data that reveals a decrease in the success of fertility treatment with age. The sooner fertility treatment is initiated, particularly as women enter their mid- to late-30s and beyond, the more effective fertility treatment will be.
Interestingly, the UK definition of medical infertility differs from the one generally accepted in the United States. Criteria for accessing state-funded IVF treatment in the UK is met after two years of unprotected intercourse in heterosexual couples. For single women or those in same-sex relationships with another woman – 12 cycles of artificial insemination, with at least six of these including intrauterine inseminations, must be undertaken before the requirement for funding of treatment is met, according to the current National Institute of Health and Care Excellence (NICE) guideline.
There are several issues that arise from the UK guideline. The first of these is that the fertile window may have closed or been significantly narrowed over the required wait prior to becoming eligible for assisted reproductive services. Secondly, this criterion completely excludes men in same-sex relationships and provides no path to parenthood for them. These criteria are sure to evolve as societies continue to move towards the adoption of a more expansive definition of the meaning of family. In fact the Women's Health Strategy outlined that the NICE guideline would be reviewed this year to remove the restriction on funding for donor sperm for women in female same-sex couples (see BioNews 1152).
In summary, the new ASRM guidelines are strongly supportive of family building as a basic human right and are broadly inclusive, meeting individuals and couples where they are, instead of pigeonholing them in such a way that only heterosexual couples unable to conceive are seen as meriting assistance with family building. It supports a wide spectrum of identities and relationship statuses, including the status of being single. It allows for a broader definition of family building that is not limited to a medical definition, in keeping with its strong support of access to care for all those who wish to become parents.
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