Assisted Reproductive Therapy: Why There is Still A Need to Form a Health Policy

Assisted Reproductive Therapy: Why There is Still A Need to Form a Health Policy

Introduction

Low birth weight and Assisted Reproductive Therapy (ART) are topics which need review. In 2005, the American Congress of Obstetricians and Gynecologists (ACOG) cited retrospective and prospective follow up studies that suggest that “pregnancies achieved by ART are associated with an increased risk of prematurity, low birth weight and neonatal encephalopathy and a higher perinatal mortality rate, even after adjusting for age, parity and multiple gestation (1). Many studies agree that women who use ART face an increased risk of having a child born with low birth weight (1,2). After researching the topic, I found a lack of new data between low birth weight and ART.

Low birth weight often leads to long-term cognitive, neurological, behavioral, and emotional issues in the child. These conditions also produce a high cost to insurance companies or to the couple while the child is in the hospital. Because of the connection between ART and low birth weight,  the medical community must address the need to educate couples seeking ART about the increased risk associated with these techniques.

Background

             ART consists of several different types of methods. Common methods include: In vitro fertilization (IVF), Zygote Intrafallopian Transfer (ZIFT) or Tubal Embryo Transfer , Gamete Intrafallopian Transfer (GIFT), and Intracytoplasmic Sperm Injection (ICSI). IVF occurs in a laboratory. An egg is fertilized and then inserted in the uterus. IVF is the most common form of ART (3). ZIFT is similar to IVF. The egg is fertilized in the laboratory and then inserted into the fallopian tube instead of the uterus. GIFT transfers eggs and sperm into the fallopian tube where fertilization occurs. ICSI is a procedure in which a single sperm is injected into a mature egg. This paper will focus on the use of IVF because it is the most common form of ART.

            In vitro fertilization (IVF) is traced back to the 1890’s when Walter Heape, a professor at the University of Cambridge, UK, reported the first known case of embryo transplantation in rabbits (4). The first human IVF pregnancy was in 1973 but ended in early embryo death (4). The birth of Louise Brown, Courtney Cross and Alastair MacDonald in 1978 marked the success of IVF (4). Since 1978 IVF has become a common procedure for infertile couples.

           Infertility occurs in women and men. Causes of infertility in women include, but are not limited to: pelvic inflammatory disease, a birth defect, polyps in the uterus,and endometriosis. Infertility in men include: antibodies which attack sperm, defects of tubules that transport sperm, and hormone imbalances. Researchers have also studied how genetics affects infertility.

           Human geneticists have been studying the how nature and the environment affect genes.                                       Geneticists have used two approaches to understand genetic traits.

One approach focuses on identifying the individual genes with variations that give rise to simple Mendelian patterns of disease inheritance ( Gregor  Mendel instead believed that heredity is the result of discrete units of inheritance, and every single unit (gene) was independent in its actions in an individual’s genome).  According to this Mendelian concept, inheritance of a trait depends on the passing-on of these units.  For any given trait, an individual inherits one gene from each parent so that the individual has a pairing of two genes. (5)  

The second approach studies how variations in genes contribute to variations in disease risk. The focus is on on understanding the genetic susceptibility to disease as the consequence of the joint effects of many genes, each with small to moderate effects and often interacting among themselves and with the environment(5).

      In the early 2000’s the study of epigenetics, the study of heritable changes in gene expression(), introduced new theories on how genes may be changed but the underlying gene sequence remains the same.  Environmental factors such as air pollution, high fat diet, neglectful mothering and child abuse may influence the addition or removal of chemical markers on DNA that affect genetic expression.  In recent times various studies implicated that, aberrant epigenetic mechanisms are associated with reproductive infertility (6).

Objectives

I propose a policy to inform couples of all risks associated with the use of ART. Couples need to be educated about and be more aware of the increased chances of low birth weight and birth defects in babies born using ART. Couples will learn how age, gestational number, and genetic traits cause for infertility. I believe it is important to further discover why there is an increased risk of low birth weight among those who use ART to conceive a child.

Issues

Genetic traits, especially amongst infertile men, signal genetic issues that may be passed onto the child (7). The ACOG proposes that, “many of the adverse obstetric outcomes associated with ART may be linked to infertility rather than the treatment for this disorder (1). It is suggested that males who are infertile not only seek genetic counseling but also participate in research to discover confounding variables.

A pregnancy outcome may also depend upon the number of fertilized eggs implanted. If too many fertilized and implanted eggs affect how the pregnancy progresses, what congenital disabilities may occur, and at what point labor begins. All of these factors may lead to low birth weight and the resulting issues that low birth weight brings with it. Methods to limit high-order gestations, pregnancies with three or more fetuses at one time, include hormone levels and folic number during superovulation, the drug-induced production of eggs for ARTs, including IVF, and limiting transfer to fewer embryos in an IVF cycle (1).

 

Policy

I suggest using the guidelines set forth by the American Society for Reproductive Medicine as a guide for further mandates, which include 1) State regulation including medical licensing requirements, requirements for continuing medical education, and discipline for physician misconduct; 2)  Federal regulation including the Fertility Clinic Success Rate and Certification Act (FCSRCA); mandatory reporting of ART cycle data to the Centers for Disease Control (CDC); Food and Drug Administration (FDA) regulation of drugs,  devices and donor tissues; and the Clinical Laboratory Improvement Act (CLIA); and 3)  Professional self-regulation including the work of the professional societies American Society for Reproductive Medicine (ASRM) and Society for Assisted Reproductive Technology (SART) to develop ethical and practice guidelines along with membership requirements;  programs for laboratory accreditation through the College of American Pathologists (CAP) and the Joint Commission; and physician board certification through the American Board of Obstetrics and Gynecology (ABOG) and American Board of Urology (ABU) (3)

    ART is one of the most highly regulated of all medical practices in the United States(8). A database of all ARTs that are provided should be kept: detailed and accurate information regarding all of the treatments that couples have undergone and all of the underlying causes of infertility would not only aid in the discovery of the causes of infertility but would identify children born after ART procedures so that their health outcomes may be tracked as well. There are already examples of such registries throughout the world, including Western Australia’s statutory Reproductive Technology Registrar and those found in Sweden and Denmark.

Another suggestion is to set up genetic counseling mandates for those seeking ART who are infertile. Genetic counseling will help those who are infertile discover if they have a genetic disease that is preventing them from conceiving or recognize genetic diseases that may affect their child. It could also serve as a tool to gather information regarding infertility and genetic diseases.

Lastly, a public relations campaign aimed at those who are seeking information on the technology of ARTs to conceive would improve access to information. The campaign would include brochures, flyers, and public service announcements that can be viewed at various clinics or physician offices. Websites and social media administered by the government could make information accessible and easy to understand, in addition to being  reviewed and refined on a regular basis. Once this is completed, a soft campaign launch, going live with the campaign but only promoting it to a network of supporters, to assess how the public feels about the information being provided will follow.

Conclusion

           ART bestows the chance for an infertile couple to have a child. The risk of complications stemming from low birth weight needs to be conveyed to prospective parents. Informing infertile couples of possible outcomes caused by ART is prudent. Enacting a policy which instructs potential parents and gathers data regarding outcomes will increase knowledge for both infertile couples and researchers working to decrease incidents of low birth weight.  

References

1.        American Congress of Obstetricians and Gynecologists, Perinatal Risks Associated With Assisted Reproductive Technology. (ACOG Committee Opinion Number 324), November, 2005.  Washington, D.C...

2.       Hansen, Michele, Bower, Carol, Milne, Elizabeth, DeKlerk, Nicholas and Kurinczuk, Jennifer.    “Assisted reproductive technologies and the risk of birth defects – a systematic review.”  Human Reproduction Oxford Journals, (February 2005): 20(2):328-338.

3.       Society for Assisted Reproductive Technology, Assisted Reproductive Technologies, accessed December 4, 2017, http://www.sart.org/SART_Assisted_Reproductive_Technologies/.

4.   Kamel, Remah Moustafa. “Assisted Reproductive Technology after the Birth of Louise Brown.” Journal of Reproduction and Infertility, (Jul-Sep 2013): 14(3): 96-109.

5. Bowler, PJ. The Mendelian revolution. “The emergence of hereditarian concepts in modern science and society.” Journal of the History of the Behavioral Sciences. (October 1990): 26:379-382.

6.   Das L, Parbin S, Pradhan N, Kausar C, Patra SK.” Epigenetics of reproductive infertility.” Front Biosci (Schol Ed). (June 2017): 1;9:509-535.

7.       Archdiocese of Dubuque, Commentary Genetic Disorders and Choices About Reproduction, 1998, September. Loras College, Catholic Healthcare Ethics.  Dubuque, IA.

8. Cohen, I, Glenn, ed. The Globalization of Health Care Legal and Ethical Issues ( Oxford University Press, 2013), 149.

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