ACTIVITY NUMBER:  MD047

ACTIVITY TITLE: Infertility and Assisted Reproductive Technology Course

ACCREDITATION STATEMENT

The American Society for Reproductive Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT

The American Society for Reproductive Medicine designates this enduring material for a maximum of 16.0 AMA PRA Category 1 Credits™.   Physicians should only claim credit commensurate with the extent of their participation in the activity.

Each participant should claim only those contact hours that he/she actually spent in the educational activity.

Release Date:  February 1, 2013

Reviewed and Updated 2016

Reviewed and Updated 2019

Expiration Date: July 1, 2022

Under Review:  July 2022          

Estimated Time to Complete Activity:  16.0 hours

NEEDS ASSESSMENT and IDENTIFICATION OF PRACTICE GAP

Infertility is a disease defined by the failure to achieve a successful pregnancy after 12 months or more of regular unprotected intercourse. Earlier evaluation and treatment may be justified based on medical history and physical findings and is warranted after 6 months for women over age 35 years.¹   Infertility affects about 7.3 million women and their partners in the U.S., about 12% of the reproductive-age population.²  A basic infertility evaluation of the couple is essential to determine the cause(s) and the appropriate treatment or need for referral.  Unfortunately, there are limited data from rigorous, controlled, clinical trials evaluating the efficacy of infertility screening tests in relation to clinical outcome, leading physicians to use other sources of guidance for their clinical practice decisions.³  Surveys of practicing board-certified reproductive endocrinologists have shown variability in the details of the performance of most testing and practice pattern differences, especially with regards to age and geographic location.³   In addition, there is lack of agreement on the roles of newer and more controversial modes of testing.⁴

Assisted reproductive technology (ART) offers infertility treatment for couples who are unable to conceive by other methods. ART includes all treatments in which both eggs and sperm are handled.  Use of ART has doubled over the past decade, and ART-born infants now account for more than 1% of all U.S.-born infants and 18% of all multiple births.⁵  In 2008, the Society for Assisted Reproductive Technologies reported that 140,795 cycles using in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), and zygote intrafallopian transfer (ZIFT) were performed in the United States.⁶  Because ART encompasses highly-specialized clinical treatments and laboratory procedures⁷,  referral by the primary care physician or obstetrician-gynecologist to a board-certified reproductive endocrinologist with an approved ART clinic enables couples to begin the process for ART in a timely manner.  The Fertility Clinic Success Rate and Certification Act (FCSRCA) of 1992 mandates that clinics performing ART annually provide data for all procedures performed to CDC, which is required to publish success rates for each clinic.  

One of the significant risks of ART is multiple gestation, yet infertility specialists appear to lack knowledge of the efficacy of single embryo transfer (SET) in reducing the multiple birth rate.  A 2009 ASRM survey of practicing reproductive endocrinologists found that fewer than half could accurately describe the appropriate use of elective SET.⁸

In addition to a review of male and female reproductive anatomy and physiology, this course addresses the causes of infertility, basic diagnostic tests for assessing the most common causes of infertility, and their interpretation.  Treatments discussed include medical therapies, the role of selected surgical procedures, and the various types of ART procedures and their clinical indications including IVF, intracytoplasmic sperm injection (ICSI), and third party reproduction. A review of genetics includes information about preimplantation genetic diagnosis.   Also discussed are indications for referral to a board-certified reproductive endocrinologist or urologist and counseling for patients regarding their prognosis and options for family building.   

1.      Practice Committee of the American Society for Reproductive Medicine. Definitions of infertility and recurrent pregnancy loss.  Fertil Steril. 2008 Nov;90(5 Suppl):S60.

2.      Centers for Disease Control and Prevention, National Center for Health Statistics. 2002 National Survey of Family Growth. U.S. Department of Health and Human Services Web site.

3.      Glatstein IZ, Harlow BL, Hornstein MD. Practice patterns among reproductive endocrinologists: the infertility evaluation. Fertil Steril. 1997 Mar;67(3):443-51.

4.      Glatstein IZ, Harlow BL, Hornstein MD. Practice patterns among reproductive endocrinologists: further aspects of the infertility evaluation.  Fertil Steril. 1998 Aug;70(2):263-9.

5.      Macaluso M, Wright-Schnapp TJ, Chandra A, Johnson R, Satterwhite CL, Pulver A, Berman SM, Wang RY, Farr SL, Pollack LA. A public health focus on infertility prevention, detection, and management. Fertil Steril. 2010 Jan;93(1):16.e1-10.

6.      Society for Assisted Reproductive Technologies. SART Cors Online Clinic Summary Report.  https://www.sartcorsonline.com/rptCSR_PublicMultYear.aspx?ClinicPKID=0.  Accessed April 6, 2010.

7.      Practice Committee of Society for Assisted Reproductive Technology; Practice Committee of American Society for Reproductive Medicine. Revised minimum standards for practices offering assisted reproductive technologies. Fertil Steril. 2008 Nov;90(5 Suppl):S165-8.

8.      American Society for Reproductive Medicine. 2009 Scientific Program Pretest Data. 

EDUCATIONAL OBJECTIVES

At the conclusion of the educational activity, participants should be able to:

1.      Describe female and male reproductive anatomy and physiology, with emphasis on the hormonal and functional changes involved in gamete production, fertilization, and implantation.

2.      Identify the causes of female and male infertility and describe appropriate workup, testing and treatment.

3.      Identify the pharmacologic agents used in hormonal and infertility treatment of females and males and explain their mechanisms of action.

4.      Select the appropriate pharmacotherapy protocols for ovulation induction and controlled ovarian stimulation cycles based on patient response.

5.      Discuss assisted reproductive technologies, including IVF and embryo transfer, intracytoplasmic sperm injection, sperm preparation techniques, and embryo cryopreservation, as well as indications and protocols for these procedures.

6.      Describe the physiology of first trimester embryo and fetal development, monitoring of infertility therapy-conceived pregnancies, components of patient education and counseling, issues related to multiple gestation, and management of early pregnancy loss.

7.      Identify patients at increased risk of genetic disorders, and common indications and techniques for genetic screening, testing and counseling.

8.      Define third party reproduction and identify appropriate screening, informed consent and counseling, compensation and cycle synchronization for gamete and embryo donation and use of gestational carrier.

9.      Summarize principles of bioethics, and discuss ethical dilemmas and legal issues as they apply to infertility treatment.

TARGET AUDIENCE

This activity is designed to meet the educational needs of physicians and allied health professionals with an interest in infertility and assisted reproductive technology care.

ACGME COMPETENCIES

Medical Knowledge

Patient Care

Interpersonal and Communication Skills

SUCCESSFUL COMPLETION REQUIREMENTS

Successful completion of the Infertility and Assisted Reproductive Technology Course requires the learner to:

·        Complete the entire series of 16 modules.

·        Read the course overview page containing all CME/CE and disclosure information, including acknowledgement of commercial support prior to the start of the activity.

·        Download and print, if desired, a syllabus containing the presentation, narrative, and exam questions.

·        Complete a 10-question pre-exam prior to each module. Learners should note any pre-exam questions answered incorrectly for clarification during module study.  

·        Participate in the interactive activity by listening to the audio narration that is synchronized with the PowerPoint presentation; this can be stopped, reversed, or advanced as desired.

·        After completion of each module take a post-exam, with a minimum score of 70 percent correct in two attempts.

·        Complete the evaluation survey.

·        Print certificate of completion.

Content Contributors and Reviewers

·        Ruben Alvero, MD - Consultant: Cooper Surgical

·        Jodie L. Asher – Employee: Integrated Genetics

·        Valerie L. Baker – Institutional Support from IBSA

·        Jean M. Benward, MS, MSW – Nothing to Disclose

·        Nancy Bowers, BSN,RN,MPH – Nothing to Disclose

·        Samantha Butts, MD - Nothing to Disclose

·        Bruce Carr, MD – Grant/Research: Evofem, Abbott, Medicines360, Merck

·        Charles C. Coddington, MD -  Ownership/Stock: Gilead, Proctor and Gamble, Merck

·        William Catherino, MD – Research/Speaker for EMD Serono; Grant/Research for Bayer and Schering Pharma

·        Owen K. Davis, MD – Nothing to Disclose

·        Michael Eisenberg, MD – Consultant: Sandstone Diagnostics, Reprovantage, Galapagos, Abbvie

·        Leslie Francis, JD, PhD –  Nothing to Disclose

·        Elizabeth Ginsburg, MD – Research for Serono

·        Sue Glitin, PhD-Nothing to Disclose

·        Elizabeth Grill, PsyD - Nothing to Disclose

·        Clarisa Gracia, MD  - Nothing to Disclose

·        Emily Jungheim, MD – Consultant: Abbvie, Genentech, Spectrum Pharmaceuticals, Celgene

·        Sigal Klipstein, MD – Nothing to Disclose

·        Sacha Krieg M.D.,Ph.D. – Nothing to Disclose

·        Benjamin Lannon, MD - Stock ownership: Dyax Corporation

·        Mark Licht, MD - Nothing to Disclose

·        Janet McLaren Bouknight, MD - Nothing to Disclose

·        Samantha M. Pfeifer, MD – Consultant: Best Doctors

·        Thomas Price, MD – Grant/Research: Bayer Pharmaceutical, Vivere Health; Consultant: GuidePoint, MedaCorp, Gerson Lehman Group, Best Doctors Consultant

·        Gail S. Prins, PhD, HCLD - Nothing to Disclose

·        Elizabeth Puscheck, MD  -  Research Grants for Wyeth and Ethicon

·        Richard H. Reindollar, MD – Nothing to Disclose

·        Ginny L. Ryan, MD, MA - Nothing to Disclose

·        Jay Sandlow, MD - Nothing to Disclose

·        David Shin, MD - Speaker's Bureau: Endo Pharmaceutical

·        James F. Smith, MD - Nothing to Disclose

·        Steven J. Sondheimer, MD – Speakers Bureau: Schering-Plough/Merck, Bayer

·        Laurel Stadtmauer, MD – Speakers Bureau: Watson Pharmaceuticals

·        Helen Tempest, PhD – Nothing to Disclose

·        Michael A. Thomas, MD – Consultant for Watson Pharmaceuticals; Grant/research:  Ferring, Medicines 360, Berlex, EvoFem

·        Thomas Toth, MD – Consultant: Good Start Genetics

·        Angela Trepanier, MS, CGC – Nothing to Disclose

·        Carin Yates, MS, CGC - Nothing to Disclose

·        Eric Widra, MD – Stock Ownership – SG Patent Holdings, LLC; Consultant: Natera, Counsyl

It is the policy of the ASRM to ensure balance, independence, objectivity, and scientific rigor in all its educational activities. All faculty/authors participating in this activity are expected to disclose any relationships they may have with companies whose products or services may be mentioned so that participants may evaluate the objectivity of the presentations. The content and views presented in this activity are those of the faculty/authors and do not necessarily reflect those of the ASRM. Any discussion of off-label, experimental, or investigational use of drugs or devices will also be disclosed. The disclosure statements were reviewed by the Subcommittee for Standards of Commercial Support of the CME Committee of ASRM and any perceived conflicts of interest were resolved in accordance with the policies of the ACCME.

ACKNOWLEDGEMENT

This CME activity is sponsored by the American Society for Reproductive Medicine.

STATEMENT OF SUPPORT

This program is supported by an educational grant from Schering Corporation, a subsidiary of Merck & Co., Inc.