Fertility market is not so infertile
The global male infertility market size was valued at USD 3.5 billion in 2019 and is estimated to expand at a CAGR of around 4.7% over the forecast period. The increasing infertility rate across the globe and adoption of assisted reproductive technologies (ARTs) are expected to drive the market for male infertility in the forthcoming years. ARTs cover a wide spectrum of infertility treatments and offer solutions for males facing problems, such as low sperm count, abnormal sperm quality, and poor motility. Moreover, ARTs offer a high success rate as compared to medications.
The market for male infertility is expected to witness significant growth in the future owing to technological advancements in the field of assisted reproductive technologies. An increase in the global prevalence of infertility is a significant clinical problem.
Around 8% to 12% of couples have to deal with the problem of infertility worldwide. Of all cases, about 40% to 50% of cases is due to male factor infertility. This may be due to one or a combination of factors, such as abnormal morphology, lower sperm concentration, and poor sperm motility. Hence, increasing male infertility and growing awareness about the same have further prompted the use of drugs, hormonal therapy, and ART.
The cryo freezing solutions for male reproductive fluids and female eggs are going to become big. The collect-from-home model solutions can be a lucrative industry. The solution providers charge $500 to $600 per annum to provide such solutions. In India, the industry is booming and will command a high market value in the future.
How to implement this idea?
Introduction
It is clear from the passage that demand for ART (Assisted Reproductive Technologies) is pegged to increase over the years. In the post COVID times, this industry is expected to grow 10.7% by 2027 from 10.3% in the pre-pandemic phase. “Due to COVID-19 pandemic, the market size of the global industry is expected to surpass $27.6 billion in 2020[1]” With rising levels of stress and dropping TFR (Total Fertility Rate), such methods provide a lucrative solution to couples trying to enter parenthood. As it is evident from the graph below that the number of children a woman can produce in her lifetime has been declining gradually for a variety of reasons that can be attributed to rising in the level of education or just to the preference of a woman or a family to produce fewer children or perhaps, trying to avoid the entire process of childbirth so that a woman can focus on her career. She can in a manner, entirely bypass the biological process involved during childbirth through ART and surrogacy.
Source: Hindustan Times
Present Scenario
Currently, there is no concrete legislation governing the functioning of such clinics, except for the rules and guidelines issued by the ICMR (Indian Council of Medical Research) the “apex body in India for the formulation, coordination, and promotion of biomedical research.”[2] However, a bill pertaining to the regulation of ART clinics had been introduced in the parliament in the year 2020, which sought to define the laws governing the issuance of licenses to ART clinics for a period of five years through the National Registry of Banks and Clinics of India to the rights of the child conceived through this procedure. It also provided for punishment and penalties in case of any ART clinic promoting sex-selective ART.[3] The bill has not yet been passed by the parliament so the arena of ART in India remains largely unregulated. The only regulatory mechanism at our disposal remains the National Guidelines for Accreditation, Supervision & Regulation of ART Clinics in India issued by the ICMR under the Ministry of Health and Family Welfare. It highlights the requirement of ART clinics, criteria for screening of patients, code of practice, ethical considerations, consent forms, categories of Infertility Care Units, establishing a National Database for Human Infertility, and future research prospects.[4]
Freezing embryos
It is a widely practiced technique to increase cumulative pregnancy rates. “Human embryos can be successfully cryopreserved at any stage from zygote to blastocyst, using 1, 2 propanediol (PROH) or dimethylsulfoxide (DMSO) for zygotes and cleaved embryos and glycerol for blastocysts. The formation of ice crystals is of concern during embryo freezing. Using programmed, slow freezers reduces this problem considerably, and slow cooling is the most widely employed method. Human embryos are known to survive a simple ultra-rapid procedure of fast cooling but there is not much data on the efficacy of these techniques when used routinely. Straws or ampoules used for freezing embryos should be carefully and permanently labeled for identification purposes.”[5]
On the basis of these guidelines, the following steps can be adopted in order to make the idea of cryopreserving gametes through a collect to home model possible:
· The guidelines prescribe for various categories of Infertility Care Units:
o Primary (Level 1A)
o Primary (Level 1B)
o Secondary (Level 2)
o Tertiary (Level 3)
· Clinics that must be registered, regulated, and supervised by the State Accreditation Authority/State Appropriate Authorities. [(Section 3.15) of the guidelines] are the ones that undertake any of the following procedures:
o “Any treatment involving the use of gametes which have been donated or collected or processed in vitro, except for AIH, and for IUI level 1A clinics who will not process the gametes themselves.
o Any infertility treatment that involves the use and creation of embryos outside the body.
o The processing or /and storage of gametes or embryos.
o Research on human embryos.
o The term ART clinic used in this document refers to a clinic involved in any one of the first three of the above activities.”
· There is a Code of Practice that needs to be complied by registered clinics:
o Staff: “A ‘person responsible’ shall take full responsibility for ensuring that the staff of the registered unit is sufficiently qualified, that proper equipment is used, that genetic material is kept and disposed off properly, and that the center complies with the conditions of its registration”
§ Failure to comply with these codes can result in the removal or prosecution of the ‘person responsible’, or the suspension of the clinic’s registration.
o Facilities: These must follow the minimum standards that a clinic is required to have in accordance with the provisions under National Guidelines for Accreditation, Supervision & Regulation of ART Clinics in India.
o Confidentiality: “No information about the treatment of couples provided under a treatment agreement may be disclosed to anyone other than the accreditation authority or persons covered by the registration, except with the consent of the person(s) to whom the information relates, or in a medical emergency concerning the patient or a court order.”
o Information to patient: “Before starting treatment, information should be given to the patient on the limitations and results of the proposed treatment, possible side-effects, the techniques involved, comparison with other available treatments, the availability of counseling, the cost of the treatment, the rights of the child born through ART, and the need for the clinic to keep a register of the outcome of a treatment.”
o Consent: “No treatment should be given without the written consent of the couple to all the possible stages of that treatment, including the possible freezing of supernumerary embryos.”
o Counselling: “People seeking registered treatment must be given a suitable opportunity to receive proper counseling about the various implications of the treatment. In Level 1B, 2, or 3 counseling is mandatory.
o Use of gametes and embryos: “No more than three oocytes or embryos may be placed in a woman in any one cycle, regardless of the procedure/ s used, excepting under exceptional circumstances (such as elderly women, poor implantation, adenomiosis, or poor embryo quality) which should be recorded. No woman should be treated with gametes or with embryos derived from the gametes of more than one man or woman during any one-treatment cycle”
o Storage and handling of gametes and embryos: The highest possible standards of storage and handling of these with regard to their recording, security and identification should be followed.
o Research: All research undertaken in such a set up must be approved by the accreditation authority. It will issue a registration certificate only after it is satisfied with the purposes of the proposed research done in public interest.
o Complaints: All such clinics are required to have a adequate procedures for accommodating complaints and grievances. The number of complaints received within a duration of one year must be communicated with the accreditation authority periodically.
· Before undertaking any such procedure, the patient must be fully informed about the procedure of cryopreservation, the risks and, particularly, what is to be done with their embryos if they do not use them. They should sign a consent form concerning the agreement for embryo freezing as well as for the future use of the embryos. [6]
· Patient Selection:
o Husband- Physical Examination, semen analysis, screening for infections and appropriate endocrinological investigations and therapy.
o Wife- Physical Examination, ‘Detection and timing of ovulation by basal body temperature (BBT), cervical mucus studies, ultrasonography, premenstrual endometrial, biopsy, histopathological examination and serum progesterone, estimation in the mid-luteal phase’, screening for local factors like cervical mucus related problems and infections, appropriate endocrinological investigations and therapy.
o Minimum age criteria: “For a woman between 20 and 30 years, two years of cohabitation/ marriage without the use of a contraceptive, excepting in cases where the man is infertile or the woman cannot physiologically conceive. For a Guidelines for ART Clinics in India woman over 30 years, one year of cohabitation/marriage without use of contraceptives. Normally, no ART procedure shall be used on a woman below 20 years.”[7] The guidelines have not prescribed any minimum age for males.
· Desirable practices/Prohibited Scenarios:
o Third party donor is to be informed that the his identity shall be concealed from the offspring and also, that he or she shall claim any rights over the child in case of a dispute.
o No ART procedure shall be done without the spouse’s consent.
o Accepted age of a sperm donor shall be 21 and 45 years
o Accepted age for a donor shall be 18 to 35 years.
o Sex selection at any stage is prohibited except to avoid the risk of transfer of any genetic abnormality.
o Collection of gametes of gametes from a dying person permitted if the widow wishes to have a child.
o “Use of sperm donated by a relative or a known friend of either the wife or the husband shall not be permitted.”
o Semen from two individuals must not be mixed before use.
o “The consent on the consent form must be a true informed consent witnessed by a person who is in no way associated with the clinic.”
o “Transfer of human embryo into a human male or into any animal belonging to any other species, must never be done and is prohibited.”
o Data of every accredited ART Clinic must be accessible to the appropriate authority of ICMR.
· Rights of a child born through ART-
o The child shall be considered to be a legitimate offspring of the parents inheriting the same privileges as enjoyed by a child through sexual intercourse.
o In case of use of donor gametes, the adoptive parents shall have a right to know about the child’s donor parents.
o Children born through donor gametes, do not have any right to know about the identity of their genetic parents however, such details can be provided to such a child once he or she becomes an adult.
o In case of divorce between parents during the gestation period, the law of the land relating to normal conception shall prevail.
· Advertisements: The marketing and advertising of such clinics has to be regulated in the sense that false claims on hoardings or paper ads are banned. Meanwhile, honest details or information with respect to the fee structure, quality of service and service provided, is encouraged provided the adhere to the rules laid down by the Medical Council of India.
· “No new ART clinic may start operating unless it has obtained a temporary registration to do so. This registration would be confirmed only if the clinic obtains accreditation (permanent registration) from the Center or State’s appropriate accreditation authority within two years of obtaining the temporary registration. The registration must be renewed every seven years.”
· ART clinics must obtain temporary registration within six months of notification of accreditation authority and permanent registration within two years.
· “If the ART clinic that has applied for a temporary registration to the appropriate accreditation authority, does not receive the registration (or a reply) within two months of the receipt of the application from the concerned office of the authority, the ART clinic would be deemed to have received the registration.”
· Human cloning is banned.
· Rights of an unmarried woman: A child born through AID (Artificial insemination through donor) to a single woman shall be considered as legitimate.
· Posthumous AIH (Artificial Insemination By Husband) through a sperm bank: Section 112 of the Indian Evidence Act, 1872 states that a child born within 280 days after dissolution or end of the marriage is to be considered as legitimate by implication. “Thus a child born to a woman artificially inseminated with the stored sperms of her deceased husband must be considered to be a legitimate child notwithstanding the existing law of presumptions under our Evidence Act.” There is no such time limitation prescribed for the child to be regarded as legitimate in case of posthumous AIH.
· Sample consent forms: The format of the forms like “Consent for Artificial Insemination with Donor Semen”, “Consent for Artificial Insemination with Husband’s Semen”, “Consent for freezing of embryos” or activities like embryo transfer has been given under Chapter IV of the guidelines.
Conclusion
Although, there is no concrete regulation such as the one introduced in the parliament previous year, these set of guidelines issued by the ICMR provide a good enough framework for the ART industry to thrive and prosper in India. There is clearly no such bar or prohibition on collection of male or female gametes from home for the purpose of utilising it for ART, thus, collect-from-home model will be a game changer for this industry benifitting the society at large.
Reference: https://main.icmr.nic.in/sites/default/files/art/ART_Pdf.pdf.
[1] https://www.globenewswire.com/en/news-release/2021/04/28/2218781/0/en/Global-Assisted-Reproductive-Technology-Market-Estimated-to-Surpass-56-3-Billion-and-Exhibit-a-CAGR-of-10-7-from-2020-to-2027-Exclusive-Report-Pages-150-by-Research-Dive.html [2]ICMR Website, https://main.icmr.nic.in/content/about-us [3] https://prsindia.org/billtrack/the-assisted-reproductive-technology-regulation-bill-2020. [4] https://main.icmr.nic.in/sites/default/files/art/ART_Pdf.pdf. [5] Ibid. [6] Ibid. [7] Ibid.
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Written by: Gayatri Chaudhary
