The Renewed Relevance of Evidence-Based Guidelines for Patient-Focused Care

Infertility Counselling

Infertility is defined as inability of a couple to conceive naturally after one year of regular unprotected sexual intercourse. Evaluation usually starts after 12 months. Indeed, some scientists consider two years without conception to be a better indicator of a couple's need for assistance when the woman is young and in absence of risk factors. However, in some situations as advanced maternal age, premature ovulation failure or clinical conditions that impact fertility an earlier intervention may be required.

Infertility is one of major clinical and social problems, affecting about one couple in six and considered as a biopsychosocial crisis. Given the prevalence of infertility and increases in the number of individuals and couples who seek infertility counselling, it has become imperative for patients to have the access to realistic and comprehensive information about their chances of having a single healthy baby, as well as risks and costs of the planned management and its alternatives.

The main goal of any type of infertility treatment is to have a healthy child. In order to achieve this objective, I believe it is fundamental that all operators (medical doctors, embryologists, nurses) have particular characteristics:

a) Honesty, knowledge and science;
b) Kindness and professionalism;
c) Ability to explain simply but exhaustively the right program and the best medical approach for each single couple;
d) Time for a consultation (40-50 minutes);
e) Availability.

However, diagnosis and treatment of infertility couples requires team work. Therefore, after the first consultation the first impression of all patients should be that a group of professionals are working to resolve their clinical condition in the best way and in the shortest period of time.

The current clinical approach to investigations and management of infertility is supported by the evidence-based guidelines issued by Royal College of Obstetricians and Gynaecologists (RCOG), American Society of Reproductive Medicine (ASRM) and European Society of Human Reproduction and Embryology (ESHRE). All professionals should follow these guidelines.

Infertility counselling is recommended as an integral part of a multidisciplinary approach. It represents an important undertaking because it offers the opportunity to explore, discover and clarify ways of having a more satisfying life when a couple has difficulty conceiving a child.

There is evidence that infertility is correlated with depression, anxiety, sexual dysfunction, and identity difficulties in both males and females. For this reason, psychosocial counselling has become valued as an integral element of assisted reproductive technology (ART) services. Stress during infertility is especially problematic because it interferes with seeking treatment. In fact, there is good evidence that people who experience fertility-related stress are less likely to not only seek treatment (Domar et al., 2012) but are more inclined to discontinue treatment than those who perceive less stress (Olivius et al., 2004; Rajkhowa et al., 2006; Brandes et al., 2009; Van den Broek et al., 2009). Thus, the management of infertility should take place in a dedicated infertility clinic staffed by an appropriately trained professional team with facilities for investigating and managing problems in both partners.

The importance of effective management of psychosocial issues in reproductive care is now firmly recognized (Boivin et al 2012). The European Society of Human Reproduction and Embryology (ESHRE) Guideline “Routine psychosocial care in infertility and medically assisted reproduction – A guide for fertility staff” offers evidence-based best practice advice to all fertility clinic staff (doctors, nurses, midwifes, counsellors, social workers, psychologists, embryologists and administrative staff) on how to incorporate psychosocial care in routine infertility care. Moreover, psychosocial care is important as it helps optimize infertility care and manage the psychological and social implications of infertility and its treatment. Infertility counsellors should also consider gender differences, the impact of infertility on a couple’s sexual relationship, and on society. For this reason, the type of counselling offered to patients must individualized and patient-centered.

Patient-focused Care

Most physician endeavour to create a culture of patient-centred care to reduce the burden related not only to the treatment, but mostly to the expectations of couples. Infertility by itself is not life-threatening, but it has devastating psychosocial consequences for infertile couples. All those working in the field of reproductive medicine understand that stress in the male and/or female partner can affect the couple’s relationship, leading to reduced libido and frequency of sexual intercourse, further aggravating the fertility problem (Bagshawe and Taylor, 2003). It remains a worldwide problem and challenge.

Management of infertility has been and still is a difficult medical task because:

• Many women know very little about the limits of their own reproductive systems;
• Of the difficulty in the diagnosis and treatment of the reproductive disorders in each partner;
• Of the fact that success of treatment depends on many factors (laboratory results, the woman's age, ovarian reserve, quality of semen etc.); and
• Despite the growth of knowledge in the field of reproductive medicine and the improvement of technology in IVF laboratories, the ability to have a child in women with euploid blastocyst is at most 50% (Ubaldi et al., 2015).

The practice of infertility counselling has become more sophisticated and widespread over the past decade. The extended embryo culture and subsequent embryo transfer at blastocyst stage, the introduction of new cryopreservation methods (oocytes and embryos vitrification) and the cycle segmentation policy have led to significant changes in the management of infertility.

For this reason, counselling must offer patients an opportunity to explore their thoughts, feelings, beliefs and their relationships in order to reach a better understanding of the meaning and implications of any choice of action they may make; counselling may also offer support when they undergo treatment and may help to accommodate expectations about the outcome of any treatment. These counselling services should be available during all stages of infertility, and  should be certainly offered before, during, and after evaluations and treatments irrespective of the outcome of the procedures. Fertility clinic staff should provide adequate services to manage all patient needs, including the availability of psychosocial resources. Even more importantly, the use of supportive psychosocial interventions and treatments are recommended for many couples with previous oncological problems, in patients with irreversible loss of their reproductive potential, or when the duration of the treatment is prolonged. Moreover, all physicians should provide sufficient information about the pros and cons of medical treatments so that the patient knows enough about the range of implications to make informed decisions.

Clinical Strategy to Improve Efficiency of IVF

Although the final goal in IVF is to have a healthy baby minimizing the risks for the patients, at the same time we must keep in mind two important principles:

1. Providing as little burden and complications  for  the  treatment as possible
2. Attain a live birth as quickly as possible but in the most safe, effective, and efficient way

To achieve these objectives all physicians should:

• Individualize controlled ovarian stimulation prediction using biomarkers of ovarian reserve along with appropriate drug selection and starting doses;
• Reduce the risk of OHSS using the GnRH antagonist protocol, GnRH agonist trigger (freeze all or aggressive luteal support) and cycle segmentation;
• Reduce the risk of multiple pregnancy with single embryo transfer (possibly at the blastocyst stage);
• Reduce the risk of miscarriage with a selection of the most viable blastocyst;
• Optimize laboratory technologies (good cryopreservation technique, blastocyst culture, selection the blastocyst with the highest implantation potential).

Meeting all these objectives could reduce the “time to pregnancy” that represents a very important aspect for infertility patients. Moreover, the drop-out rates reported among couples undergoing IVF treatment show large variation, from 23% up to 45% and 60% between different countries as well as IVF centres within the same country (Domar et al 2010; Van den Broeck U et al 2009; Bodri D et al 2014). Many factors can affect the drop-out: cost of treatment, reimbursement policies, accessibility to infertility services, etc. (Brandes M 2009; Roest J 1998). For this reason, we should reduce the drop-out rate by avoiding unnecessary tests and treatments that are not in accordance with the scientific society guidelines. And again, all possible strategies should be discussed and shared with the couple as they relate to their medical background, in line with their expectations and their unique clinical condition.

Conclusions:

Infertility counselling should be offered before, during and after evaluations and treatments, irrespective of the outcome of these procedures. Patient needs includes an honest, ethical, experienced, patient, available, kind, efficient and modern IVF team. “Patient-focused care” means having an effective and efficient approach in terms of birth of a healthy child, also offering an IVF treatment with the highest chance of success per started cycle while reducing the real patient burdens, including OHSS, multiple pregnancies, as well as poor laboratory techniques, equipment and conditions. All strategies during infertility treatment should provide a patient-focused approach. Preventing age-related infertility is the responsibility not only of doctors and medical practitioners, but also of the society in general.  

This resource is supported by an educational grant from Merck KGaA, Darmstadt, Germany.

Bibliography:

Bagshawe A, Taylor A. ABC of subfertility. Counselling. BMJ. 2003 Nov 1;327(7422):1038-40. Review.

Boivin J, Domar AD, Shapiro DB, Wischmann TH, Fauser BCJM, Verhaak C. Tackling burden in ART: An integrated approach for medical staff. Hum Reprod. 2012.

Boivin J, Takefman J, Braverman A. Development and preliminary validation of the fertility quality of life (FertiQoL) tool. Simultaneous publication. Hum Reprod. 2011;26(8):2084–2091.

Brandes M, van der Steen JO, Bokdam SB, Hamilton CJ, de Bruin JP, Nelen WL, Kremer JA. When and why do subfertile couples discontinue their fertility care? A longitudinal cohort study in a secondary care subfertility population. Hum Reprod. 2009 Dec;24(12):3127-35.

Bodri D, Kawachiya S, De Brucker M, Tournaye H, Kondo M, Kato R, Matsumoto T. Cumulative success rates following mild IVF in unselected infertile patients: a 3-year, single-centre cohort study. Reprod Biomed Online. 2014 May;28(5):572-81. Epub 2014 Jan 24.

Dancet EAF, Nelen WLDM, Sermeus W, Leeuw L, Kremer JAM, D’Hooghe TM. The patients’ perspective on fertility care: A systematic review. Hum Reprod Update. 2010 Sep-Oct;16(5):467-87.

Domar AD, Smith K, Conboy L, Iannone M, Alper M. A prospective investigation into the reasons why insured United States patients drop out of in vitro fertilization treatment.
Fertil Steril. 2010 Sep;94(4):1457-9.

E.A.F. Dancet, I.W.H. Van Empel2, P. Rober,W.L.D.M. Nelen, J.A.M. Kremer, and T.M. D’Hooghe. Patient-centred infertility care: a qualitative study to listen to the patient's voice

Gameiro S, Boivin J, Dancet E, de Klerk C, Emery M, Lewis-Jones C, Thorn P, Van den Broeck U, Venetis C, Verhaak CM, Wischmann T, Vermeulen N. ESHRE guideline: routine psychosocial care in infertility and medically assisted reproduction-a guide for fertility staff.
Hum Reprod. 2015 Nov;30(11):2476-85.

Roest J, van Heusden AM, Zeilmaker GH, Verhoeff A. Cumulative pregnancy rates and selective drop-out of patients in in-vitro fertilization treatment. Hum Reprod. 1998 Feb;13(2):339-41.

Ubaldi FM, Capalbo A, Colamaria S, Ferrero S, Maggiulli R, Vajta G, Sapienza F, Cimadomo D, Giuliani M, Gravotta E, Vaiarelli A, Rienzi L. Reduction of multiple pregnancies in the advanced maternal age population after implementation of an elective single embryo transfer policy coupled with enhanced embryo selection: pre- and post-intervention study. Hum Reprod. 2015 Sep;30(9):2097-106.

Van den Broeck U1, Holvoet L, Enzlin P, Bakelants E, Demyttenaere K, D'Hooghe T. Reasons for dropout in infertility treatment. Gynecol Obstet Invest. 2009;68(1):58-64.

Verhaak CM, Lintsen AME, Evers AWM, Braat DDM. Who is at risk of emotional problems and how do you know? Screening of women going for IVF treatment. Hum Reprod. 2010;25:1234–1240.