Understanding Infertility, Evaluations, and Treatment Options

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1 Understanding Infertility, Evaluations, and Treatment Options Arlene J. Morales, M.D., F.A.C.O.G. Fertility Specialists Medical Group, Inc.

2 What We Will Cover Introduction What is infertility? Briefly review female reproduction Evaluating fertility Fertility testing Treatment options Common procedures

3 Introduction Definition: The inability of couples of reproductive age to establish a pregnancy within 1 year through unprotected sexual intercourse 1 In the United States, 7.3 million women (12% of women of reproductive age) had difficulty or were unable to get pregnant or carry a baby to term 2 Only 50% receive treatment With treatment, 2 of 3 couples will succeed 1. Practice Committee of the American Society for Reproductive Medicine. Fertil Steril. 2008;90(5 suppl):s Chandra et al. Vital Health Stat ;(25):1.

4 There Are Multiple Causes of Infertility Multiple factors (male + female) 18% Causes of Infertility Tubal factor 14% Ovaluatory dysfunction 6% Multiple factors (female only) 13% 6% 7% Diminished ovarian reserve Endometriosis Unexplained 11% Other causes 6% 19% 1% Uterine factor Male factor Centers for Disease Control and Prevention Assisted Reproductive Technology Success Rates: National Summary and Fertility Clinic Reports Accessed April 20, 2009.

5 Decline in Fertility With Age: The Fixed Ovarian Pool Becomes Depleted as Time Passes 1.2 Monthly Fertility Rate 1.0 Relative rate Broekmans et al. Trends Endocrinol Metab. 2007;18:58. Female age (y)

6 ART: Pregnancy and Birth Rates Still Decrease With Women s Age 60 FER Infertility DT6 04/21/11 14:06 50 Percent < >48 Age (years) Pregnancy Live birth Singleton live birth *For consistency, all percentages are based on cycles started. Centers for Disease Control and Prevention Assisted Reproductive Technology Success Rates: National Summary and Fertility Clinic Reports Accessed April 20, 2009.

7 Determinants of Declining Fertility With Advancing Age in Women Declining oocyte number and ovulatory disturbances Declining oocyte quality and increasing chromosomal and genetic mutations Luteal phase dysfunction Impaired fertilization rates Implantation failures Poor-quality embryos and genetic abnormalities Impaired endometrial receptivity Higher incidence of age-related gynecologic problems, including uterine fibroids and polyps Declining sexuality Increased pregnancy wastage Early implantation failures and preclinical losses Clinical losses Increased incidence of general medical problems accompanying aging (eg, type 2 diabetes mellitus, hypertension) High incidence of obstetric complications and poor pregnancy outcomes Pal and Santoro. Endocrinol Metab Clin North Am. 2003;32:669.

8 The Female Reproductive Tract Image on file with Organon, a part of Schering-Plough.

9 The Ovary Netter illustrations used with permission of Elsevier Inc. All rights reserved.

10 FER Infertility DT6 04/21/11 14:06 The Brain Controls Reproduction Hypothala mus Pituita ry Image on file with Organon, a part of Schering-Plough. Netter illustration used with permission of Elsevier Inc. All rights reserved.

11 Menstrual Cycle Recruitment of Follicles Selection of Dominant Follicle LH Surge Implantation Follicular Phase Luteal Phase Day 1 Day 7 Day 14 Days or Days Day 28 Window of Receptivity American Society for Reproductive Medicine. Age and fertility: a guide for patients Accessed April 20, 2009.

12 The Hormones Gonadotropin-Releasing Hormone (GnRH) Released by the hypothalamus, acts on pituitary Coordinated pulse frequency Follicle-Stimulating Hormone (FSH) Released by the anterior pituitary, acts on ovary Luteinizing Hormone (LH) Released by the anterior pituitary, acts on ovary Estrogen (E2) Produced by the growing follicle, acts on endometrium Progesterone (P4) Produced by the corpus luteum (CL) and placenta, acts on endometrium American Society for Reproductive Medicine. Age and fertility: a guide for patients Accessed April 20, 2009.

13 FER Infertility DT6 04/21/11 14:06 How Hormones Interact Hypothalamus Coordinated GnRH Pulses Pituitary Estrogen FSH & LH Ovary Image on file with Organon, a part of Schering-Plough.

14 The Cycle:...Oocyte,...Uterus,...Hormones Netter illustration used with permission of Elsevier Inc. All rights reserved.

15 Normal Fertilization and Implantation FER Infertility DT6 04/21/11 14:06 Image on file with Organon, a part of Schering-Plough.

16 When to Suspect a Problem If the woman is under 35 and has tried unsuccessfully to conceive for more than 12 months Or if the women is over 35 and has tried for more than 6 months If the couple meets either of these criteria, then the couple may need to be evaluated Although couples frequently turn to their Ob/Gyn for initial fertility guidance, referral to an infertility specialist, a reproductive endocrinologist (RE), may be necessary Practice Committee of the American Society for Reproductive Medicine. Fertil Steril. 2006;86(5 suppl):s264. Taylor. BMJ. 2003;327:494.

17 Evaluating Female Fertility Clinical Need Routine Tests FER Infertility DT6 04/21/11 14:06 First Exam Ovulatory status Patient history and physical exam Midluteal serum progesterone Ultrasound scanning Endometrial biopsy Basal body temperature Ovarian reserve Basal LH, FSH, E 2, inhibin B, anti-müllerian hormone, FSH:LH ratio Clomiphene citrate, exogenous FSH, or GnRH antagonist testing Uterine factors Ultrasound scanning Hysteroscopy Hysterosalpingography (HSG) Tubal factors HSG Fluoroscopic tubal cannulation Chromotubation Bowen et al. Fertil Steril. 2007;88:390. Practice Committee of the American Society for Reproductive Medicine. Fertil Steril. 2006;86 (5 suppl):s264. Taylor. BMJ. 2003;327:494.

18 Endometrial Biopsy Delayed endometrial maturation from inadequate P4 production by the CL could cause infertility and early pregnancy loss Histologic dating of the endometrium via biopsy has been used for the evaluation of CL function and diagnosis of luteal phase deficiency (LPD) However, a single biopsy is not sufficient to make the diagnosis Therefore, most REs do not believe that histologic dating is a good diagnostic tool Murray et al. Fertil Steril. 2004;81:1333.

19 Transvaginal Ultrasound Image on file with Organon, a part of Schering-Plough.

20 Hysteroscopy Septum Polyp Tim Peters and Company, Inc. Peapack, NJ 07977, USA.

21 Hysterosalpingography (HSG) Tim Peters and Company, Inc. Peapack, NJ 07977, USA.

22 Evaluating Male Fertility Clinical Need First exam Semen analysis Additional analyses Routine Tests Reproductive/medical history Physical examination Ejaculate volume ph Sperm concentration Total sperm number Percent motility Forward progression Normal morphology Sperm agglutination Viscosity Basal hormone analysis: FSH, LH, testosterone, prolactin Postejaculatory urinalysis Ultrasonography Testicular biopsy/exploration Genetic screening Specialized semen and sperm analyses Male Infertility Best Practice Policy Committee of the American Urological Association; Practice Committee of the American Society for Reproductive Medicine. Fertil Steril. 2006;86(5 suppl):s202. Taylor. BMJ. 2003;327:494.

23 Male Infertility Normal sperm quality: Count: > /ml Morphology: >30% Motility: >50% Image on file with Organon, a part of Schering-Plough Male Infertility Best Practice Policy Committee of the American Urological Association; Practice Committee of the American Society for Reproductive Medicine. Fertil Steril. 2006;86(5 suppl):s202. Taylor. BMJ. 2003;327:494.

24 Treatment Options for Infertile Couples Condition Treatment Options Female infertility Ovulatory failure or dysfunction Tubal factor Endometriosis OI COS with IVF IUI (patent tubes), or COS with IVF Male infertility Male subfertility Male factor Female and/or male infertility Unexplained IUI with or without OI COS with ICSI IUI, COS with IVF, or ICSI OI = ovulation induction; COS = controlled ovarian stimulation; IVF = in vitro fertilization; IUI = intrauterine insemination; ICSI = intracytoplasmic sperm injection. National Institute for Clinical Excellence. Fertility assessment and treatment for people with fertility problems Accessed April 20, 2009.

25 Ovulation Induction OI is useful in patients with anovulatory infertility WHO class I: hypogonadotropic hypogonadism WHO class II: polycystic ovary syndrome (PCOS) Goal Stimulate development of a single follicle that will be able to reach preovulatory size and rupture Options Clomiphene citrate (CC) Gonadotropins (hmg/fsh followed hcg) GnRH analogue Messinis. Hum Reprod. 2005;20:2688. Practice Committee of the American Society for Reproductive Medicine. Fertil Steril. 2008;90 (5 suppl):s7. Practice Committee of the American Society for Reproductive Medicine. Fertil Steril. 2006;86(5 suppl):s187.

26 Ovulation Induction: Clomiphene Citrate CC is an antiestrogen that binds to estrogen receptors and interferes with estrogen-negative feedback Results in an alteration in pulsatile GnRH secretion Leads to increases in gonadotropin secretion and follicular development CC is widely used for ovulation induction in women with PCOS and in couples with unexplained infertility CC treatment successfully induces ovulation in about 80% of properly selected candidates Pregnancy rates are much lower (30%-40% per cycle) 40%-45% of couples can become pregnant within 6 cycles Failure to conceive after successfully induced ovulation is indication for further evaluation Patient characteristics predictive of poor response to CC: Hypothalamic disorder Low estrogen levels Obesity American Society for Reproductive Medicine. Medications for inducing ovulation: a guide for patients Accessed April 20, Case. Can Fam Physician. 2003;49:1465. Practice Committee of the American Society for Reproductive Medicine. Fertil Steril. 2006;86:S187.

27 Limitations and Risks With CC for OI CC is generally well tolerated, although some side effects may limit its efficacy and safety Short-term, reversible side effects include: hot flashes, mood swings, visual disturbances, breast tenderness, pelvic discomfort, and nausea The antiestrogenic effects may negatively impact the uterine lining, leading to lower pregnancy rates Risk of multiple pregnancy is increased Risk of cancer is increased among women who were treated with CC Uterine fibroid risk increases with CC treatment Risk of ovarian cancer increases among women treated with prolonged CC Treatment should be limited to no more than 6 cycles or fewer in consideration of woman s individual situation Age, baseline characteristics, etc Althuis et al. Am J Epidemiol. 2005;161:607. Case. Can Fam Physician. 2003;49:1465.

28 Ovulation Induction: Gonadotropin Treatment FER Infertility DT6 04/21/11 14:06 Optimal for women who have failed CC or who cannot risk waiting Used in women with inadequate pituitary secretion of LH and FSH (hypogonadotropic amenorrhea) or PCOS Agents: FSH, hcg, human menopausal gonadotropin (hmg) Success rates WHO class I: 30% per cycle WHO class II: 17% per cycle May include IUI or natural intercourse OI hcg American Society for Reproductive Medicine. Medications for inducing ovulation: a guide for patients Accessed April 20, Practice Committee of the American Society for Reproductive Medicine. Fertil Steril. 2008;90(5 suppl):s7.

29 Use of IUI in OI Protocol Indications Unexplained infertility Male subfertility mild oligozoospermia, asthenozoospermia, or teratozoospermia Failure to conceive after ovulation induction treatment Ejaculatory failure Retrograde ejaculation Procedure Washed prepared sperm are deposited in the uterus just before the release of an egg or eggs in a natural or stimulated cycle Success rate: up to 15% per cycle Significant risk for multiple pregnancy Image on file with Schering-Plough/Organon. FER Infertility DT6 04/21/11 14:06 Rowell and Braude. BMJ. 2003;327:799.

30 In Vitro Fertilization Procedure Initially used in women with fallopian tube blockage or damage Now employed for many causes of infertility (eg, endometriosis, male factor) Involves COS Egg retrieval Insemination, fertilization, embryo culture Embryo transfer Cryopreservation of extra embryos Risks Ovarian hyperstimulation syndrome (OHSS) Usually not serious and resolves with outpatient management 1%-2% severe requiring hospitalization Dose-dependent, avoided by careful titration Anesthesia Multiple births Ectopic pregnancy Cost Psychologic distress American Society for Reproductive Medicine. Assisted reproduction technologies: a guide for patients Accessed April 20, 2009.

31 Intracytoplasmic Sperm Injection Indications Very low numbers of motile sperm Severe teratospermia Problems with sperm binding to and penetrating the egg Antisperm antibodies Prior or repeated fertilization failure with standard IVF methods Frozen sperm limited in number and quality Obstruction of the male reproductive tract not amenable to repair Success Rate and Complications Fertilization rate: 50%-80% Live offspring: 20%-40% (40% in younger women; success declines with maternal age) American Society for Reproductive Medicine. Intracytoplasmic sperm injection (ICSI) Accessed April 20, Campbell and Irvine. Br Med Bull. 2000;56(3):616. Palermo et al. Sem Reprod Med. 2000;18(2):161.

32 Controlled Ovarian Stimulation: Gonadotropin Treatment Starts with higher dose of gonadotropins than for OI (COS: IU of FSH; OI: IU of FSH) Needs GnRH analog treatment to prevent interference by endogenous hormones COS is followed by oocyte retrieval, IVF, and transfer of embryos COS hcg Arslan et al. Fertil Steril. 2005;84(3):555. Borini and Dal Prato. Reprod Biomed Online. 2005;11:283.

33 Common Procedures: COS hcg Day 2 or 3 of menses Day 6 of FSH Embryo Transfer Cycle day GnRH antagonist rfsh/hmg GnRH agonist rfsh/hmg IVF or ICSI Luteal phase support Down regulation

34 How can the Ob/Gyn and specialist work together to ensure that patients get the most appropriate treatment as soon as possible? Ob-Gyn Patient Fertility Specialist

35 Management Algorithm for Ob/Gyn Couple attempting conception Female <35 years of age 1 year of infertility Determine progesterone level 7 days after presumed ovulation Anovulation or oligo-ovulation without hirsutism Female >35 years of age 6 months of infertility Ovulation Consider referral for COS Female physiology: serum-sensitive TSH, FSH, and prolactin levels Abnormal Normal Refer to fertility specialist Male evaluation: semen analysis Abnormal Female anatomy: hysterosalpingography Abnormal Treatment: clomiphene citrate mg/d orally for 5 days during menses, for 3 cycles Successfu l Initiate prenatal care Hanson and Dumesic. Mayo Clin Proc.1998;73:681. Unsuccessfu l

36 Summary Infertility treatment protocol and success rates are highly dependent on ovarian age Associated risk factors increase with age (eg, endometriosis) as well as other risks (chromosomal abnormalities) Conduct diagnostic tests after 1 year of infertility for woman aged <35 years 6 months of infertility for woman aged >35 years Multiple techniques exist to assess ovulatory function, and several different types of protocols treat female infertility Most treatments have higher rates of success in younger women The Ob/Gyn, fertility specialist, and patient need to work together to determine reasonable expectations and optimal treatment course

37 Thank You Arlene J. Morales, M.D., F.A.C.O.G. Fertility Specialists Medical Group, Inc.

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