Educational and Supportive Care to Depressed Infertile Females
Condition: Infertility, Female; Depression; IVF
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      Infertility affects married adults, and In Vitro Fertilization (IVF) is an Assisted
      Reproductive Technology (ART) that can be treated. Women undergoing IVF are more likely to
      experience depression. There is a need to reduce depression by supporting and advising
      sufferers. The aim of this study is to evaluate pharmacist counseling's impact on pregnancy
      rates in depressed infertile females during IVF treatment.
    

Detailed description: 
      Infertility affects 10-15% of couples, both men and women, and can cause anxiety, worry,
      grief, and disappointment. It is a major life experience that can affect all aspects of a
      couple's life. Preconception counseling is a necessary prerequisite for infertility
      treatment, as it evaluates the medical, social, genetic, environmental, and occupational
      factors that influence fertility and pregnancy health. Depression is a common issue among
      infertile females, and pharmacists play a crucial role in the care of depressed patients.

      The etiology of female infertility is unknown, but ovulatory disorders, endometriosis, pelvic
      adhesions, tubal blockage, other tubal abnormalities, and hyperprolactinemia account for 81%
      of all cases. Age has a negative impact on fertility, and the prevalence of age-related
      infertility rises as reproductive years decrease. Treatment for infertility aims to resolve
      treatable causes and overcome intractable ones. General management principles for infertile
      couples include determining the cause and treatment, suggesting changes in behavior that
      increase fertility, stopping smoking, and limiting exposure to harmful substances.

      Assisted reproductive technology (ART) is used to treat infertility, which involves fertility
      therapies involving both eggs and sperm. In vitro fertilization (IVF) is widely recognized as
      the most effective method of ART. IVF is one of the most successful therapies for
      infertility, but it sometimes requires multiple attempts at oocyte picking and embryo
      transfer. It is effective in treating undiagnosed infertility, obstructed or broken fallopian
      tubes, genetic disorders, women with uterine fibroids, ovulation problems, or early ovarian
      failure, and women who have had their ovaries surgically removed.

      The IVF cycle involves ovarian stimulation, which involves fertility drugs to stimulate egg
      production and regulate ovulation. Examples of ovarian stimulation regimens include
      leuprolide acetate, also known as Lupron, which is used in conjunction with birth control
      pills for the first week. Anti-estrogens like clomiphene citrate, also known as Clomid, are
      used to manage anovulation by selectively modulating estrogen receptor activity.
      Follicle-stimulating hormone (FSH) is a medication that stimulates the ovaries, potentially
      serving as an alternative therapeutic option for women with anovulation who have undergone
      unsuccessful cycles of anti-estrogens. Human chorionic gonadotropin injections (HCG) are
      commonly used to induce ultimate maturation, stimulating ovulation when there is at least one
      fully developed ovarian follicle. The American Society for Reproductive Medicine advises the
      transfer of a specific quantity of embryos, whether they are in a fresh or frozen state.

      Emotional changes in IVF patients are common, with anxiety and depression being more common
      in infertility patients with psychiatric illness, miscarriage, a longer infertility timeline,
      and a definitive medical diagnosis. Stress levels increase as therapy becomes more intensive
      and lasts longer, making IVF patients more stressed than women at the beginning of their
      infertility examination.

      Infertility and its medications can cause emotional distress for patients, especially those
      who have tried multiple IVF cycles without success. Patients may lack familiarity with
      gonadotropin self-injection, hormone supplements, and other necessary treatments for
      ovulation induction cycles. Studies show that depression lowers IVF pregnancy rates, but the
      impact on emotional distress is uncertain.

      Grief responses are frequently observed among couples experiencing infertility, but typical
      grief responses can progress into pathological grief, resulting in notable melancholic
      symptoms. In women, the prevalence of infertility depression ranges from 10-25%, with women
      experiencing major depression at rates two to three times higher than men. Depression can
      negatively impact treatment, follow-up, and confidence for the future, as well as the
      intensity and durability of the affected couple's relationship. The Centre for
      Epidemiological Studies Depression Scale (CES-D) measures depression symptoms across various
      demographics, including race, ethnicity, gender, and age.

      The Fertility Quality of Life Tool (FertiQoL) is an internationally validated instrument
      designed to measure the quality of life in people experiencing infertility. The FertiQoL
      questionnaire is beneficial for infertile patients due to its strong construct validity and
      reliable psychometric properties.

      Pharmacists play a significant role in education and supportive care for depressed patients,
      providing advice, recommendations, and counseling about medications, monitoring patients for
      drug-related problems, and assessing patient adherence. The modern pharmacist's
      responsibilities include pharmaceutical care principles, transforming them from a traditional
      medication seller into a critical member of the healthcare team. The goal of these
      patient-centered interventions is to improve therapeutic outcomes by recognizing, preventing,
      and treating drug-related problems, encouraging the correct use of medication, and promoting
      and educating about general health.

      Pharmaceutical care is a systematic, complete approach that requires pharmacists to work with
      the healthcare team to detect and treat drug-related difficulties and safeguard patients from
      medicine-related damage. The idea of care focuses on developing the pharmacist-patient
      connection and adding value to the therapeutic outcome by actively participating in the
      treatment method.

      Evidence-based medicine (EBM) is a practice that combines the results of recent scientific
      studies with the input of clinicians and patients. The shift in pharmacy practice from
      perception to evidence-based practice is crucial for optimal pharmacological treatment. The
      Institute of Medicine aims to achieve 90% of healthcare decisions backed by accurate, latest
      clinical information by 2020.

      Collaborative counseling has been shown to reduce stress levels in infertile women receiving
      IVF by 3.6 times compared to the control group. Psychotherapy is an appealing choice in terms
      of treatment, as it has been shown to increase patients' chances of becoming pregnant.

      In most countries, psychological counseling or interpersonal therapy and behavioral
      activation are the first-line treatments for depression.

      These studies have shown that infertile women who want to undergo IVF may fail and not get
      pregnant due to the patient's depression condition prior to the operation.

      As a result, health education and awareness must be undertaken, and a satisfactory condition
      must be provided prior to the operation, with a focus on women because they are more
      susceptible to this depression than men.

      The key issue is depression in infertile women, which has an impact on the pregnancy rate
      outcome. There is a need to reduce depression by supporting and advising sufferers.

      Aim of study This study examines the effect of depression on the pregnancy rate of infertile
      ladies during IVF procedures and the use of counseling and supporting care by pharmacist to
      evaluate outcomes of IVF cycles, as measured by clinical pregnancy rates recorded after the
      intervention. The secondary outcome: assessment of both groups completed the CES-D scale and
      FertiQoL during the start-time and end-time of the IVF procedure.
    

Intervention name(s): Educational and supportive care
Intervention type(s): Behavioral
Intervention description(s): The trial had a total of 75 participants assigned to the intervention group, whereby they were provided with an educative and supporting program specifically developed by a clinical pharmacist. The intervention group was provided with assistance via a series of five visits, which included an initial visit upon admission, subsequent visits for monitoring medication, ovulation, and negative effects, as well as visits dedicated to giving emotional support. Additionally, a follow-up visit was conducted after the egg collecting process and embryo transfer.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study included 75 patients in the intervention group who received an educational and supportive program designed by a clinical pharmacist. The intervention group received support through five visits: at admission, monitoring medication, monitoring ovulation, monitoring harmful effects, providing emotional support, and following up after egg retrieval during embryo transfer.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Education; Supportive care; Pharmacist