Infertility, a global medico-socio-cultural problem

There are more than 186 million ever-married women of reproductive age (15–49) in developing countries (except China) who were unable to have a child within 5 years of unprotected sexual intercourse . Infertility is not only a medical problem but also a socio-cultural problem. In many developing countries, woman’s social status, her dignity, and self-esteem are often closely related to her ability to conceive and have children . In developing countries, the psychological and social consequences of infertility are often suffered by the female partner even if she is not the cause of infertility . A recent systematic assessment of the available evidence on association between infertility in women of reproductive age and risk of intimate partner violence (IPV) confirmed that infertility is a risk factor for IPV in LICs and MICs .

As a result of profound societal changes, there can be delay in marriage and the age of child bearing, which contributes to infertility. Generally, women frequently choose a long-term work career and often wait for the stability of a permanent job and a stable marriage or relationship before planning a family. The UN statistics in July 2011 showed that the mean age of women who gave birth to their first child in 2008 has risen to almost 30 in some countries such as United Kingdom, Germany, Spain, Switzerland, and Luxembourg. Women often do not realize that fertility declines with age. Natural cycle fecundity, the chance of a couple conceiving in a given month, for a healthy young woman is 20–25% and declines with advanced maternal age . A recent survey of 1000 young people from across the UK, commissioned by the Royal College of Obstetricians and gynecologists and the British Fertility Society revealed worrying gaps in their knowledge of reproductive health and the decline of fertility with age. Eighty percent of both sexes believed that women’s fertility starts to decline after the age of 35. Twenty-five percent of boys and 16% of girls believed that women’s fertility starts to decline after 40 .

Evolution of bioethics and infertility treatment

Bioethics is the study of ethical issues arising in healthcare and biological sciences. Bioethics also includes the study of the social, legal, and economic matters related to these ethical issues . Bioethics as defined by the WHO is a field of ethical enquiry that examines ethical issues and dilemmas arising from health, healthcare, and research involving humans . Though ethics seemed an entirely academic discipline, yet in the field of infertility particularly in ART, bioethics is all about patients and women wanting to have a baby. How should we handle the difficult and the unusual requests, and what policies should we adopt? How should we balance justice, utility, and equity? How should we balance the rights of the woman and the welfare of the future child? How should we balance patient’s autonomy, with evidence-based information and being truly nondirective? How should we balance patients’ rights and physician’s conscientious objections to provide a certain modality in ART? How should we balance positive rights and negative rights when states regulate ART services in various countries?

With the advent of ART with the birth of Louise Brown in the UK on July 25, 1978, it became possible to separate reproduction from sexual intercourse. Indeed, ART enabled women to conceive without having sexual intercourse. Therefore, ART allowed the involvement of a third party in the process of reproduction, whether by providing an egg, a sperm, an embryo, or more recently a uterus . ART also opened the way for other practices including gender selection, preimplantation genetic diagnosis (PGD), preimplantation genetic screening, genetic manipulation, cryopreservation of gametes, embryos and gonads, gonadal transplantation, nuclear transfer, and cloning. These clinical changes challenged the age-old perception of reproduction and consequently provoked intense ethical debate that continues with the introduction of more new practices in ART.

The originally proposed excellent four ethical principles of respect for autonomy, justice, beneficence, and non-maleficence by Beauchamp and Childress since the early eighties do not adequately address ethical issues in ART. UNESCO expanded the ethical principles to 15 principles (articles 3–17) and linked them to human rights in the Universal Declaration on Bioethics and Human Rights adopted by the United Nations Member States .

Societies differ in their practice of medical bioethics based on social, cultural, economic, religious, and legal differences. There can be tension between law and ethics. What is an ethically acceptable decision is not always legally permitted and what is legally permitted is not always ethically permissible. Such diversity is strikingly apparent in infertility treatment, particularly in ART. Progressive Scandinavian countries such as Sweden and Norway have enacted restrictive ART legislations against third-party donation and surrogacy in the process of reproduction. Spain, a traditionally Roman Catholic country with a large Muslim population, is now a popular destination for infertile women to have cross-border ART because it permits third-party involvement in ART . Likewise, third-party involvement in ART is available in Lebanon to both Muslims and Christians, but not in neighboring countries such as Egypt or Italy .

Ethical issues in fertility treatment

Different modalities exist for the treatment of infertility for both the male and female partners, depending upon the cause of infertility. Some of these modalities had been practiced for hundreds of years and were of little or no ethical concern. Medical therapy, hormonal therapy, corrective and reconstructive surgery for male or female infertility are some of these modalities. These treatments were not of major ethical concern because they did not separate sexual intercourse from reproduction. Reproduction was still only possible when both partners had sexual intercourse for months or years after undergoing treatment. These modalities are usually incorporated in the basic healthcare service facilities in most of the countries. As a consequence, patients, poor or rich, can usually access these infertility treatments without discrimination on the basis of color, nationality, or religion.

The birth of Louise Brown in England in 1978 has created a great deal of ethical debates, disagreements, and controversies worldwide. This event also raised several issues concerning needs, availability, accessibility, reproductive choices, human rights, moral status of the embryo, and conscientious objection to treatment.

Ethical issues in ART

ART babies born globally reached 6.5 million in 2012, based on an estimated 1.9–2.2 million cycles being performed and the delivery of around 480,000 babies each year, representing a delivery rate of 19.5% per aspiration and a cumulative rate of 28.9% . This means that globally for a couple to achieve a single live birth, the female partner will have to go through an average of three ART cycles. In countries where ART is not sponsored or subsidized by the state or health insurance, as is the case in most of the countries, most patients will not be able to have access to ART and having ART involves a huge financial burden for the couple. A large percentage of couples paying for ART out of their pocket will stop after having the first or second ART cycles and before they succeed to have a baby .

Three ethical principles that provide an ethical basis for ART are as follows: the principle of liberty, which guarantees a right to freedom of action; the principle of utility, which defines moral rightness by the greatest good for the greatest number; and the principle of justice, which requires everyone to have equal access to necessary goods and services as a matter of fairness. Medical ethics is based on the moral, religious, philosophical ideals and principles of different societies in which it is practiced. Therefore, it is not surprising to find what is ethically permissible in one society might be considered ethically impermissible in another. It is therefore essential for the practicing physicians, and critics of conduct to be aware of such diverse cultural backgrounds before making judgments about diverse medical practices.

The ethical values and judgments of the infertile couple and healthcare provider alike are usually influenced by the societal values and judgments, which reflect the interest of theologians, demographers family planning administrators, physicians, policy makers, sociologists, economists, and legislators. Responsible policy makers in the medical profession in each country have to decide on what is ethically acceptable in their own country, guided by the international guidelines, which should be tailored to suit their own society. The physician has to be concerned about the legality of his acts, which are undertaken on the basis of ethical precepts. Those for whom religion is important need to distinguish between medical ethics and humanitarian considerations, on the one hand, and religious teachings and national laws, on the other hand.

Needs for ART

Globally, there is a huge demand and unmet need for ART, particularly in developing countries. A health economic report in 2002 puts the lowest estimate of global need for ART at 1500 cycles per million populations per year (mppy), assuming that only 50% of couples who need ART will have it done. In Europe, Belgium and Denmark had the highest provision of ART in 2013, with more than 2000 cycles of ART/mppy. Leading countries such as France, the Netherlands, and the UK were each below 1000 cycles/mppy .

Access to ART is dependent not only on the wealth of the country but also on the distribution of wealth and the health policy, health insurance system, and social and religious determinants in each country. As the cost of establishing and maintaining ART centers is high, meeting such costs is not a priority for many healthcare systems in LICs and MICs. However, justice, equality, equity, and social responsibility demand that people should not be denied healthcare services on the basis of their social background. It follows that a mechanism should be found to provide ART service for those who cannot afford having the service at expensive private ART centers . The challenging task will be to simplify ART and reduce its cost so that it becomes available and affordable in LICs and MICs.

ART as practiced today is very complex and expensive and coincides with much patient discomfort and increased chances for complications resulting in considerable rates of discontinuation and reduction of proportions of couples achieving pregnancy . Many couples who need ART worldwide will not be able to get it because of high cost associated with it and the reluctance of insurance companies to reimburse it. It is therefore mandatory to prevent infertility and apply other alternative options available for the management of infertility. The choice of treatment should be patient-centered.

Availability and accessibility to ART

Despite massive global expansion of ART services over the past decade (2005–2014), ART remains unavailable in many parts of the world, particularly in Sub-Saharan Africa, Eastern Europe, mid-Central and Southern Asia, and Latin America. In the recent IFFS Surveillance, 2016 data on ART could be obtained only from 74 countries of the 194 member states of WHO . Although this represents an increase of 14 countries from the 2013 IFFS Surveillance , a large number of countries still do not have ART services. In addition to this limited availability, accessibility to the existing ART service is mostly limited to the rich and the elites while the poor are deprived from access to this service. This situation is worsened by the trend of some healthcare providers, particularly in developing countries, who push hard to offer ART service for their infertile couples as the first line of treatment without trying first other evidence-based, effective, safer, and cheaper modalities of treatment. This can be facilitated by misleading the public through commercial advertisements quoting very high success rates of ART.

Because of the rapid increase in the cost of medical technologies, economics not uncommonly influences countries’ decisions about providing one service or another based on the available resources and the principle of utility: the greatest good for the greatest number. It is often argued in LICs and MICs that the solution to the problem of infertility is not providing expensive ART services, but preventing postpartum infection, unsafe abortion, iatrogenic infertility, tuberculosis, schistosomiasis, and STIs, which are among the prevailing causes of infertility in many LICs and MICs . However, not providing such service to the infertile couples would be unjust in these countries. Every effort should be made to reduce ART cost. The service to the needy may be provided through donation, charitable projects and companies, research projects, health insurance, establishing public ART centers, and applying low cost or natural IVF cycles. Satellite clinics may cooperate with ART centers in larger cities to reduce the cost of establishing many ART centers in the country.

Reproductive choice

ART has made it possible for the infertile couples to ask for certain reproductive choices, which may not be available in their own countries. Reproductive choice is the right of the person to choose freely to exercise or supplement his or her reproductive capacity. Although reproductive choice is basically a personal decision, some may argue that it is not totally so. This is because reproduction is a process that involves not only the person who makes the choice but also the other partner, the child to be born, the family, society, and the world at large. It is therefore not surprising that the reproductive choice is often influenced by the diverse contexts, sexual mores, cultures, and religions, as well as the official stance of different societies .

The reproductive choice of the person not uncommonly conflicts with the ART practices and legislations in his or her own country. Not all societies permit all forms of ART. Every day many people cross national borders to fulfill a reproductive choice, which may not be permitted in their own countries. Such acts are by no means restricted to one country or followers of one religion. Many Muslims fly to Europe or the United States to fulfill a reproductive choice that they cannot have in their own country. The same behavior also exists in Europe among residents of some European countries who have restricted access to certain practices in ART such as egg donation, PGD, surrogacy, oocyte banking for social indications, or sex selection. The birth of a baby to a postmenopausal British woman who had ART in Italy made the news worldwide at the time .

With the development of science and technology in ART, some practices such as uterine or ovarian transplantation or nuclear transfer for mitochondrial disease became available in some developed countries but not in others. Some couples who are well off and can afford the cost of such treatment will cross borders to have such treatment modalities. However, the poor and the needy couples will continue to be deprived of access to such treatment.

Human rights and positive and negative rights

Bioethics is very closely related to human rights. Human rights recognized the legal entitlement to found families in the universal Declaration of Human Rights, 1948 in its Article 23. The modern evolution of human rights no longer requires legal marriage as a condition of family foundation, but outside more conservative societies, non-traditional families and their participant’s rights to access ART are recognized.

In the absence of legal prohibition, couples and qualified healthcare providers are free to seek and provide ART services. However, in doing so, healthcare providers should anticipate the family and social settings into which the child to be born with the goals of minimizing risks and harmful social consequences. Surrogacy and pregnancy in the post-menopause using ART are typical examples of such practices. Post-menopausal pregnancy using egg donation, in countries where it is allowed, raises ethical concerns if a relatively older woman intends to rear the child she bears. A recent removal and placing for adoption of an Italian female child born as a result of cross-border ART to a father aged 70 and a mother aged 57, because the child was left alone in the car for a number of hours, is a typical illustrative example . The Italian court stated that the decision to remove the child was not due to her parents’ age but was solely motivated by a concern for the child’s welfare because of poor parenting . It becomes an ethical obligation of the healthcare provider’s team in such cases to check for the background of the parents to be for family instability, records of previous child abuse, or neglect for the interest of the child to be born. However, healthcare providers cannot ethically or legally discriminate on grounds such as applicant race, religion, or sexual orientation unless so required by law. Assessment of parenting adequacy should therefore be made very carefully and without bias.

Legal regulation of ART in some countries may contradict human rights. Costa Rica’s constitutional court ruled in 2000 that ART was unlawful and violates embryos’ right to life, but the Inter-American Court of human Rights ruled in 2012 that this prohibition was itself a violation disproportionate to the obligation to protect prenatal life. The Court affirmed that the effects of the prohibition on the right to private life, intimacy, reproductive autonomy, access to reproductive health services, and to found a family are severe because these rights are annulled for those persons whose only possible treatment for infertility is IVF (para 314) . Accordingly, legal provisions that impair or otherwise complicate patients’ access to and practitioners’ provision of ART may be challenged as denials of patients’ human rights .

When resources are limited, ART services may not be provided by public funds, which should be utilized to provide basic healthcare needs for the greatest sector of the population. This creates tension between the ethical principles of justice, the equal right of every person to treatment, and utility, and the greatest good for the greatest member. This exposes the distinction in human rights law and ethics, between positive and negative rights. Positive rights are those that states are legally obliged, or that they voluntarily choose, to make available by supply of funding or by provision of facilities and/or personnel. Most human rights are negative, meaning that states cannot prohibit or unduly obstruct services of which individuals may avail themselves but that states have no duty to provide .

Jewish perspectives

Judaism is the first and oldest monotheistic faith. The first command from God to Adam after he was created “Be fruitful and multiply” (Genesis 1:28). This commandment has been interpreted as an obligation to reproduce.

The basis of the Jewish law and tradition (Halakha) guides the religious practices and numerous aspects of everyday life. Halakha is composed of the Written Law and the Oral Law. The foundation of the Written Law is the Torah, which is the first five books of the Scripture. Torah is the origin of authority in Judaism as it is derived from the original revelation from God to the prophet Moses and the Jewish people on Mount Sinai. The Torah contains Ten Commandments and all Jews adhere to the Ten Commandments. The Oral Law interprets and explains the Written Law and regulates new rules, practices, and customs not mentioned in the Written Law. The Oral Law includes the Mishnah, the Talmud, the post-Talmudic codes, and the Responsa.

The Mishnah was established in the third century and included early traditional and original interpretations of the written Torah, ancient regulations not written in the Torah and post-biblical regulations. Three centuries after the compilation of the Mishnah, the great interpreters studied the six orders to the Mishnah and wrote a monumental composition, the Talmud. The great interpreters (Amoriam) included the Talmud commentaries and interpretative studies of the Mishnah and established regulations and new customs. The Amoriam in Babylon composed the Babylonian Talmud, while the Amoriam in the Holy Land composed the Jerusalem Talmud .

The Bible does not make any direct reference regarding the beginning of human life. Procreation is acknowledged in the Bible as a gift of god. The Bible says ”God formed a man from the dust of the earth and breathed into his nostrils the breath of life and the man became a living soul” (Gen. 2.7) The Babylonian Talmud states “The embryo is considered to be “mere water” until the 40th day. After that, it is considered sub-human until it is born .

Roman catholic perspectives

The Vatican considers the moral status of the embryo begins at conception, and thus, the Vatican bans all ART practices . The sanctity of life is considered absolute from the moment of fertilization. The Vatican puts an absolute value on the unbreakable nexus between coitus and conception and forbids the faithful to any practice that bypasses the sexual union of man and woman in sexual intercourse. Although marriage confers upon the spouses the right to perform the natural acts of conjugal love which aim at procreation, the child is not an object, but a gift from God to the married couple .

Christian, non-catholic churches’ perspectives

Protestantism, unlike Catholicism, is not a centralized religion. It is composed of many independent churches having different moral and ethical standards. The protestant churches cannot declare a certain position to be the “official” position because there is a direct bond between the Bible and the believer.

Every Christian is personally responsible for all his or her acts, including using ART. Human dignity, personal rights, and self-determination have to be respected in each act in ART. The supersession of the old Mosaic covenant including traditional Halakha, the traditional Jewish Law maintained in Catholicism, by the new covenant and by Christian theology have an important impact on protestant ethics in reproductive medicine .

Most protestant theologies and bioethics do not consider the embryo as an independent human being. The embryo before having a nervous system, organ differentiation, and pain receptors cannot be considered as a human being with full moral status. However, the early stages of the embryo ethically require a special status as a “human life” worthy of respect. The rights of the embryo increases gradually with its age and development. Consequently, the zygote is not a “human being.” The early stages of an embryo ethically merit a special status as they already have human life but are not yet “human being” .

The Arminian theology, founded by Dutch Jacobs Arminius (1560–1609), Anglican Church founded by Henry VII in 1534 and other many churches have no major differences concerning the morality of the embryo.

Islamic perspectives

Instructions that regulate everyday activity of life to be adhered to by an observant Muslim are called Shari’aa. There are two sources of Shari’aa in Islam: primary and secondary. The primary sources of Shari’aa in a chronological order are as follows: the Holy Quran, the very words of God, the Sunna and Hadith, which are the authentic traditions and sayings of the Prophet Muhammed as collected by specialists in Hadith, Igmaa, which is the unanimous opinion of Islamic scholars or Aaimma and analogy (Kias), which is the intelligent reasoning, used to rule on events not mentioned by the Quran and Sunna, by matching current concerns against similar or equivalent events previously ruled on (which is casuistic or case-based ethical reasoning). The secondary sources of Shari’aa are Istihsan, views of Prophet’s companions, current local customs if lawful, and public welfare and rulings of previous divine religions if not contradicting the primary sources of Shari’aa. An observant Muslim resorts to secondary sources of Shari’aa in matters not dealt with in the primary sources. Even if the action is forbidden, it may be undertaken if the alternative would cause harm. Shari’aa accommodates different opinions as long as they do not conflict with the spirit of its primary sources and are directed to the benefit of humanity. The broad principles of Islamic jurisprudence are permissibility unless prohibited by a text (Ibaha), no harm, and no harassment; necessity permits the prohibited and the choice of the lesser harm .

In the Quran, the development of the embryo and fetus advances step by step with its morphological development and growth, from a clot to a lump of flesh then boned flesh and finally a fully gown infant (Sura El Hag 22:5; Sura El Momenon 23:14). Up to 40 days, the embryos in the mother’s womb is a “nutfa,” then an “alaqa” for an equal period, and then a “mudgha.” Organ differentiation occurs in 42 days after fertilization. Ensoulment of the fetus occurs after 120 days following fertilization, although some authorities consider it to occur as early as 42 days post-fertilization. Thus, the embryo cannot be considered as a “human being” before 40 days after fertilization at the earliest. This old threshold of 40 days and upwards from conception has been brought to as early as 14 days by researchers because recent progress in embryology has established that individuality of the “new being” cannot begin before this date . This concept has been affirmed by scholars and researchers from various Muslim countries during the international seminar on “Dilemma of Stem Cell Research” held in Cairo in November 2007. Embryo handling for treatment or research and benefit of humanity is allowed before 14 days after fertilization. .

Conscientious objection

Although in the past ethics has been greatly influenced by religious beliefs, the past two decades have witnessed the secularization of bioethics. Religion and medical traditions no more dominate bioethics in most societies. Bioethics became more dominated by philosophical, social, and legal concepts . However, in some societies such as Muslim and Catholic societies, religion continues to have a substantial influence on law and the acceptability of various ART practices in these societies. Not uncommonly in such societies and elsewhere in the world, conscientious objection of some healthcare providers to some ART practices as egg donation, sperm donation, or surrogacy hinders provision of the service to the infertile couples. Similarly, some infertile couples may have conscientious objection to certain ART practices such as egg donation or sperm donation. Healthcare providers should not impose upon the couple what they view as the appropriate solution to their problem. It is the duty of the physician to meet the healthcare needs of their patients according to the patient’s ethical percepts if this does not conflict with the accepted standards of healthcare. If the physician has a conscientious objection to treatment, it is the duty of the physician to refer couples to where their needs can be provided. With practitioners and patients alike having increasing global mobility, practitioners are likely to see patients with ethical percepts different from their own. Such patients should not be deprived from access to their reproductive choice based on conscientious objection of the healthcare provider.