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Ethical considerations for telemedical delivery of fertility care: an Ethics Committee opinion (2024)

Telemedicine has the potential to increase access to and decrease the cost of care. However, it also alters the nature of the physicianpatient relationship and the interaction of patients with the healthcare system, which may limit access to care in some circumstances. Regardless of the modality of care delivery, the basic tenets of medical ethics and the obligations of physicians to their patients still hold. (Fertil Steril® 2024;121:434–8. ©2024 by American Society for Reproductive Medicine.)

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KEY POINTS

  • Telemedicine delivery via telephone has benefits related to the ease of use, but raises concerns regarding the quality of care, patient identification, and the lack of physical examination capabilities.
  • Telemedicine video visits, in contrast to telephone visits, require broadband as well as access to technologies, such as smartphones, laptops, personal computers, tablets, and broadband, which may present barriers for some patients and increase disparities in access to care.
  • When caring for a patient via telemedicine, the overarching ethical obligations inherent to the physician-patient relationship remain unchanged.
  • To the extent possible, physicians should aim to create a telehealth environment that resembles an in-person clinic visit.
  • Physicians who use electronic communication to answer patient health questions should ensure that mechanisms exist to protect patients’ identity and personal information, and to prevent unauthorized viewing of and access to private health information.

 
The evolution of digital infrastructures has allowed substantial growth in the ability of physicians to deliver medical care remotely. Telemedicine may decrease care costs and improve patient access to primary and specialty services. It also has a role when it is unsafe to travel for care, such as during a pandemic or natural disaster, and when patients have difficulty physically traveling to a medical facility due to health or transportation limitations. However, telemedicine also alters the nature of the physician-patient relationship and patients’ interaction with the healthcare system. In this Opinion, major ethical considerations associated with the telemedical delivery of reproductive medicine are reviewed. The overarching ethical obligations inherent to the physician-patient relationship remain unchanged whether care is provided remotely or in person.

 

OVERVIEW OF TELEMEDICAL MODALITIES/ TERMINOLOGY

Synchronous vs. Asynchronous

Telemedicine is defined as the practice of medicine at geographically distinct locations via a remote electronic interface. Telemedicine can be divided into synchronous and asynchronous interactions. Synchronous interactions allow for a direct patient-to-provider interaction with the delivery of medical expertise. This is a real-time experience, with a live component occurring at a set time. This is the modality used for scheduled telemedicine clinic visits. A physician participates directly in the patient’s clinical care in real time via telecommunication and is held accountable for the care being provided. Asynchronous interactions refer to the ‘‘store-and-forward’’ technique, where a patient sends their medical history, images, and test results to their physician for diagnostic and treatment expertise. This modality may be used to send messages through ‘‘portals’’ that link to the electronic medical record. In these, the patient may send their physician a message, similar to an email, which the physician receives at a later time (or conversely, physicians may reach out to and communicate with patients).

 

Audio Only vs. Audiovisual

Although using the telephone for telemedical visits provides ease of use, it also raises concerns related to quality of care, patient identification, and the lack of physical examination capabilities. Compared with audio-only visits, video visits allow at least some aspect of a physical evaluation. They also may facilitate a more personal connection between clinicians and patients. However, video visits require a more complex setup and broadband internet access, which may present barriers for some people. Finding the balance between using telemedicine, either audio or video, maximizing access to medical care, and maintaining the quality of care likely will continue to evolve.

 

PATIENT-PROVIDER VS. PROVIDER-PROVIDER

Telemedicine may be used for communication between clinicians about patients, in addition to more traditional telemedicine between clinicians and patients. Clinician-to-clinician telemedicine may be either synchronous or asynchronous and may be used for ‘‘curbside’’ consultation regarding challenging cases, during multidisciplinary case review (e.g., a ‘‘tumor board’’ for cancer care), or for remote instruction during procedures (i.e., ‘‘telementoring’’). Generally, a patient-clinician relationship is not established by a consulting clinician who has not directly evaluated a patient (virtually or in person); therefore, the ethical obligations stemming from a therapeutic relationship generally do not apply to these interactions. However, it is good clinical practice to ensure that primary responsibility for patient care and follow-up is established clearly after such interactions between clinicians. Again, ethical standards of care for patients cared for in person should be used as a guide.

 

THE USE OF TELEMEDICINE IN REPRODUCTIVE CARE

Care conducted via telemedicine may be episodic (e.g., a single consultation) or recurrent (e.g., serial follow-up). Each of these modalities may create different ethical obligations for clinicians, as they imply different physician-patient relationships.

Clinicians conducting single remote consultations may have very limited obligations to establish subsequent contact with patients. No subsequent visits or laboratory testing will be needed for some patient encounters or single consultations. Conversely, clinicians who establish an ongoing relationship with patients seen virtually should set up effective mechanisms to respond to patients’ questions, communicate laboratory results, and maintain care. The modalities used to communicate effectively with patients may differ, but the ethical underpinnings of respect for autonomy, nonmaleficence, and maintaining confidentiality do not differ. Expectations for future contact between clinicians and patients should be made clear during the initial encounter to ensure that patients understand the nature of the remote relationship and to whom they should bring ongoing concerns. Likewise, physicians have the same obligations to contact patients with laboratory and imaging results, regardless of whether additional patient contact was planned otherwise.

The limited data on the use of telemedicine specific to fertility care suggest that although outcomes are similar compared with face-to-face visits, patients seen remotely had longer durations of infertility, lived farther from the clinic and had shorter visits (1). For new patients, no difference was seen for cancellation rates, diagnoses, and the number of clinic contacts made before starting treatment. For follow-up visits, no differences were identified for treatment recommended, percent that received treatment, and time to treatment initiation. Pregnancy and time-to-pregnancy rates were similar between telemedicine and face-to-face groups.

 

GROUP PATIENT EDUCATION/SUPPORT

Different uses of telehealth give rise to differing levels of accountability for physicians. On a group basis, some clinics or physicians may have webinars for patients starting in vitro fertilization, information that was conveyed previously in person. The information provided is generalized and intended for more general consumption. In these situations, patients should have contact information for the clinic directly so that any individual questions that come up during the online educational session can be answered. It should be stated clearly during webinars that the information provided does not constitute a physician-patient relationship and that a formal consultation should be arranged to establish this. The disadvantage of webinar-based education is the frequent lack of an interactive component, and physicians using this technology must ensure that means of communication are available for patients to meet their needs.

 

PHYSICIAN/PATIENT RELATIONSHIP

Although telehealth has the potential to increase access to fertility care, there also is the potential for it to alter the physician/patient relationship. Although in the past physician visits were performed in a clinic or private space, converting these to telehealth may create a more casual environment. From the patient’s perspective, these may feel more like a FaceTime call and less like a doctor’s visit. Patients may have more distractions in their home environment than there would be in a traditional office setting. Physicians should attempt to create a telehealth environment that feels as close as possible to an in-person clinic visit. As telehealth becomes a more accepted and consistent option for patient care, it is possible that a structured ‘‘code of telehealth conduct’’ or ‘‘telehealth etiquette’’ may become a part of preparing for these visits.

 

PHYSICAL EXAMINATION, QUALITY OF ANCILLARY TESTING

Telemedicine represents a substantial change from the traditional face-to-face mode of seeing patients, resulting in a limited ability to perform a physical examination (2). Although not every patient encounter requires a physical examination, established clinical standards of care must continue to be met. One limitation of remote visits discussed in the aforementioned study on telemedicine in the reproductive endocrinology and infertility practice identified the lack of information regarding vital signs, including height and weight. These were recorded in 93.4% of in-person visits vs. none with telemedicine. It is important that physicians are aware of a patient’s risk profile, including body mass index and blood pressure status, when planning for treatment. Having a full picture of these factors ensures patient safety and optimizes success when providing fertility care. Concerns have been raised about the lack of physical face-to-face interaction in telemedicine and the possibility that this could handicap the clinician in making an accurate diagnosis (3). Likewise, the physical examination is important in cases of male infertility to evaluate for testicular size, masses, vas presence, and the presence of varicoceles. The role of ultrasound as a substitute for in-person physical male examinations is under evaluation.

 

PHYSICIAN RESPONSIBILITY REGARDING DIGITAL TECHNOLOGIES

Physicians who offer telemedicine have a responsibility to familiarize themselves with this modality and its limitations. They should have mechanisms in place to care for patients when the digital connection is lost. They should be aware of any privacy concerns related to the technologies they use. They should become proficient in the use of digital technologies before incorporating these in their care model. They should ensure that they have appropriate access to the internet and backup systems to ensure that their digital connection is stable and consistent.

 

EQUITY IN ACCESS TO CARE

Data show that 21 million people lack broadband internet access in the United States, many from underserved communities that also face worse health outcomes (4). Likewise, a recent study suggests that 13 million older adults are not ready for telemedicine visits due to difficulties using technology (5). Data looking at which groups may not have access to telehealth exist. Older patients, Asian patients, and non-English-speaking patients had lower rates of telemedicine use, whereas older patients, female patients, Black, Latinx, and poorer patients had less video use (6). Several studies have identified racial and income status as factors that correlate with telemedicine use rates (7, 8). From an ethical perspective, low-income patients may face unique barriers to accessing video visits when they lack the technical devices, internet access, and other infrastructure to conduct these visits. Some patients also may lack technologic literacy, which may limit their desire to attempt to use these technologies.

 

PRIVACY

Telemedicine encounters involve a wider range of third parties than traditional medical encounters, including telecommunications service providers and health care personnel involved in checking patients in remotely. Some encounters are protected under privacy laws and regulations, but others may not be protected and may carry additional risks. Physicians who use electronic communication to answer patient health questions must be diligent in ensuring that mechanisms exist to protect the patient’s identity. Physicians engaging in telemedicine should have protocols in place to prevent unauthorized viewing and access and protect patient information’s security.

When engaging in telemedicine clinic visits, the virtual nature of telemedicine can make it difficult to ascertain who is present and able to view and hear the interaction between physician and patient. Physicians are responsible for being aware of who is present and obtaining consent from the patient to share information that others will hear or see in the space. The same rules for maintaining confidentiality in the face-to-face fertility clinic setting should be followed in the remote care setting. Given the sensitive nature of a couple’s fertility information, physicians should use platforms that optimize the protection of patient health data. This may include minimizing the use of unsecure messaging systems.

 

REGULATORY CLIMATE

Physician and provider reimbursement issues for telehealth are a moving target. Before the pandemic, telephone visits seldom were reimbursed (9, 10). Furthermore, the Centers for Medicare & Medicaid Services has indicated that reimbursement for telephone visits may discontinue as recovery from the COVID-19 pandemic continues (11). Additional considerations include telehealth across state borders and physician licensure regulations related to this. Physicians engaging in telehealth should undergo the same credentialing/training/expertise required for telemedical care as for in-person care. For some patients, these potential barriers may mean losing access to medical care due to a lack of video telemedicine or transportation for face-to-face care. Physicians practicing telehealth should consult with local legal and regulatory experts when considering developing their capability for telemedical care.

 

CONCLUSION

Telemedicine has tremendous potential to increase access to and decrease the cost of care. However, telemedicine may alter the nature of the physician-patient relationship and patients’ interaction with the healthcare system. From an ethical perspective, low-income patients may face unique barriers in accessing video visits when they lack the technical devices, internet access and other infrastructure to conduct these visits. Some patients may also lack technological literacy, which may limit their desire to even attempt to use these technologies. For some patients, these potential barriers may mean losing access to telehealth medical care. Physicians practicing telehealth should consult with local legal and regulatory experts when considering developing their capability for telemedical care. Establishing a clinician-patient relationship leads to the same overarching ethical requirements for clinicians, regardless of whether care is provided virtually or in person.

 

Acknowledgments: This report was developed under the direction of the Ethics Committee of the American Society for Reproductive Medicine as a service to its members and other practicing clinicians. Although this document reflects appropriate management of a problem encountered in the practice of reproductive medicine, it is not intended to be the only approved standard of practice or to dictate an exclusive course of treatment. Other plans of management may be appropriate, taking into account the needs of the individual patient, available resources, and institutional or clinical practice limitations. The Ethics Committee and the Board of Directors of the American Society for Reproductive Medicine have approved this report.

This document was reviewed by ASRM members and their input was considered in the preparation of the final document. The following members of the ASRM Ethics Committee participated in the development of this document: Sigal Klipstein, M.D.; Deborah Anderson; Ricardo Azziz, M.D., M.P.H., M.B.A.; Kavita Shah Arora, M.D., M.B.E.; Tolulope Bakare, M.D.; Katherine Cameron, M.D.; Susan Crockin, M.D.; Ruth Farrell, M.D.; Elizabeth Ginsburg, M.D.; Catherine Hammack-Aviran, M.A., J.D.; Mandy Katz-Jaffe, Ph.D.; Jennifer Kawwass, M.D.; Edward Martinez, M.D.; Joshua Morris, M.D., M.A.; Catherine Racowsky, Ph.D.; Robert Rebar, M.D.; Eli Reshef, M.D.; Mary Samplaski, M.D.; Chevis N Shannon, Dr.PH, M.P.H., M.B.A.; Hugh Taylor, M.D.; Sean Tipton, M.A.; Lynn Westphal, M.D.; Julianne Zweifel, Ph.D.. All Committee members disclosed commercial and financial relationships with manufacturers or distributors of goods or services used to treat patients. Members of the Committee who were found to have conflicts of interest based on the relationships disclosed did not participate in the discussion or development of this document.

 

REFERENCES


  1. Alexander VM, Schelble AP, Omurtag KR. Traits of patients seen via telemedicine versus in person for new-patient visits in a fertility practice. F S Rep 2021;2(2):224–9.
  2. Chaet D, Clearfield R, Sabin JE, Skimming K. Council on Ethical and Judicial Affairs American Medical Association. Ethical practice in telehealth and telemedicine. J Gen Intern Med 2017;32:1136–40.
  3. Clavijo R, Ramasamy R, Halpern J, Melnick A, Stewart J, Rosenwaks Z. ‘‘Online’’ and ‘‘at-home’’ versus traditional models of health care: enhancing access or impeding optimal therapeutics? Fertil Steril 2020;114:476–82.
  4. Federal Communications Commission. 2019 broadband deployment report. Federal Communications Commission. May 29, 2019. Available at: https:// www.fcc.gov/reports-research/reports/broadband-progress-reports/2019-broadband-deployment-report. Accessed March 4. 2023.
  5. Lam K, Lu AD, Shi Y, Covinsky KE. Assessing telemedicine unreadiness among older adults in the United States during the COVID-19 pandemic. JAMA Intern Med 2020;180:1389–91.
  6. Eberly LA, Kallan MJ, Julien HM, et al. Patient characteristics associated with telemedicine access for primary and specialty ambulatory care during the COVID-19 pandemic. JAMA Netw Open 2020;3:e2031640.
  7. Chunara R, Zhao Y, Chen J, Lawrence K, Testa PA, Nov O, Mann DM. Telemedicine and healthcare disparities: a cohort study in a large healthcare system in New York City during COVID-19. J Am Med Inform Assoc 2021;28:33–41.
  8. Weber E, Miller SJ, Astha V, Janevic T, Benn E. Characteristics of telehealth users in NYC for COVID-related care during the coronavirus pandemic. J Am Med Inform Assoc 2020;27:1949–54.
  9. California Department of Health Care Services. Telehealth definitions. Available at: https://www.dhcs.ca.gov/provgovpart/Pages/telehealthdefinitions. aspx. Accessed March 7. 2023.
  10. Centers for Medicare & Medicaid Services. Telemedicine. Available at: https:// www.medicaid.gov/medicaid/benefits/telemedicine/index.html. Accessed March 7, 2023.
  11. Centers for Medicare & Medicaid Services. Proposed policy, payment, and quality provisions changes to the Medicare physician fee schedule for calendar year 2021. Available at: https://www.cms.gov/newsroom/fact-sheets/proposed-policy-payment-and-quality-provisions-changes-medicare-physician-fee-schedule-calendar-year-4. Accessed March 7. 2023.

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Surgery Coding

I took the ASRM coding course, and in that course, coding for bilateral neosalpingostomies was coded using only a dx of N70.11 (hydrosalpinx). View the Answer
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Telephone Consult

Does a physician need to speak directly to a patient to code for a telephone consult (99371-99373) or can a staff member relay physician notes to patients? View the Answer
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Post Vasectomy Infertility

If a husband has had a vasectomy, does the sterilization code apply to the wife's visits? View the Answer
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Pregnancy Of Uncertain Viability Ultrasound

My staff is telling me that I am getting reimbursed for the first sonogram and OB visit (using ICD 10 code for pregnancy of uncertain viability – O36.80X0. View the Answer
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Pregnancy Ultrasound

Our practice does routine ultrasounds (sac check- 76817) at the end of an IVF cycle and bill with a diagnosis code O09.081, pregnancy resulting from ART.  View the Answer
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Psychological Evaluation

Many REs require patients (and their spouses/partners) who are considering using donor gametes to see an infertility counselor first. View the Answer
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Infertility Consult

Does ASRM have any examples of evaluation and management documentation for patients being seen for an initial infertility evaluation? View the Answer
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Infertility Consult by Nurse

What code is used for a nurse practitioner seeing a fertility patient for the first time? View the Answer
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Initial Visit for Infertility With No Mandated Coverage

What code would be appropriate for an initial visit for infertility?  View the Answer
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IUI or IVF

Should other ovarian dysfunction (diagnosis code E28.8) or unspecified ovarian dysfunction (diagnosis code E28.9) can be used for an IUI or an IVF cycle View the Answer
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Monitoring E&M

Our group would like to know if others are billing an evaluation and management code for ultrasound and blood draw visits? View the Answer
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New vs Established Patient

How soon can you bill as a new infertility patient? View the Answer
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General E&M Consult

Recently we have received a “re-code” on a new patient (we billed a 99203 and the insurance re-coded it to a 99213).  View the Answer
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Hysteroscopy Recurrent Implantation Failure

What is the appropriate ICD-10 code for recurrent implantation failure?  View the Answer
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D&C Under Ultrasound Guidance

What are the CPT codes and ICD-10 codes for coding a surgical case for a patient with history of Stage B adenocarcinoma of the cervix ... View the Answer
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Diagnosis of Infertility for IVF Procedure

How important is it to have accurate documentation of the type of infertility diagnosis for IVF procedures?  View the Answer
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Diagnostic Testing of an Infertile Couple

The Z31.41 is or is not the correct code to use for diagnostic testing of an infertile couple? And If so can if be used as the primary and only code? View the Answer
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Blood Draws

If a patient comes in only for a blood draw (venipuncture) and is seen only by the lab technician (not an MD, PA, or NP), may we bill for a (minimal) office visit? View the Answer
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Blood Tests

Patients are requesting to have lab work drawn from the female patient moved to the males account due to the female fertility coverage being maxed out.  View the Answer
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Male Infertility

A summary of common codes for Male Infertility compiled by the ASRM Coding Committee. View the Coding Summary
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ASRM müllerian anomalies classification 2021

The Task Force set goals for a new classification and chose to base it on the iconic AFS classification from 1988 because of its simplicity and recognizability. View the Committee Opinion
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Intracytoplasmic sperm injection (ICSI) for non–male factor indications: a committee opinion (2020)

Intracytoplasmic sperm injection is frequently used in combination with assisted reproductive technologies. View the Committee Document
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Moving innovation to practice: an Ethics Committee opinion (2021)

The introduction of new strategies, tests, and procedures into clinical practice raises challenging ethical issues. View the Committee Opinion
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Fertility evaluation of infertile women: a committee opinion (2021)

Diagnostic evaluation for infertility in women should be conducted in a systematic, expeditious, and cost-effective manner. View the Committee Opinion
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Fertility treatment when the prognosis is very poor or futile: an Ethics Committee opinion (2019)

The Ethics Committee recommends that in vitro fertilization (IVF) centers develop patient-centered policies regarding requests for futile treatment.  View the Committee Opinion
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Use of exogenous gonadotropins for ovulation induction in anovulatory women: a committee opinion (2020)

Pretreatment evaluation, indications, treatment regimens, and complications of gonadotropin treatment. View the Committee Opinion
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Reproductive and hormonal considerations in women at increased risk for hereditary gynecologic cancers: Society of Gynecologic Oncology and American Society for Reproductive Medicine Evidence-Based Review (2019)

Providers who care for women at risk for hereditary gynecologic cancers must consider the impact of these conditions. View the Joint Statement
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Guidance for Providers Caring for Women and Men Of Reproductive Age with Possible Zika Virus Exposure (Updated 2019)

This ASRM guidance specifically addresses Zika virus infection issues and concerns of individuals undergoing assisted reproductive technologies (ART). View the Guideline
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Current recommendations for vaccines for female infertility patients: a committee opinion (2018)

Encounters for infertility care are opportunities to assess and update immunization status. View the Committee Opinion
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American Society for Reproductive Medicine position statement on uterus transplantation: a committee opinion (2018)

Following the birth of the first child from a transplanted uterus in Gothenburg, Sweden, in 2014, other centers worldwide have produced scientific reports. View the Committee Opinion
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Child-rearing ability and the provision of fertility services: an Ethics Committee opinion (2017)

Fertility programs may withhold services on the basis that patients will be unable to provide minimally adequate or safe care for offspring. View the Committee Opinion
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Removal of myomas in asymptomatic patients to improve fertility and/or reduce miscarriage rate: a guideline (2017)

This review evaluates if uterine myomas impact likelihood of pregnancy and pregnancy loss, and if myomectomy influences pregnancy outcomes. View the Guideline
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Subclinical hypothyroidism in the infertile female population: a guideline (2015)

There is controversy regarding whether to treat subtle abnormalities of thyroid dysfunction in the infertile female patient. View the Committee Guideline
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Improving the Reporting of Clinical Trials of Infertility Treatments (IMPRINT): modifying the CONSORT statement (2014)

Clinical trials testing infertility treatments often do not report on the major outcomes of interest to patients and clinicians and the public. View the Guideline