Robin L. Poe-Zeigler, MD, FACOG. Dr. Robin

Transcription

1 Robin L. Poe-Zeigler, MD, FACOG Dr. Robin

2 The INVOCell Solution INVOcell Device and Procedure Explained

3 BASICS OF HUMAN REPRODUCTION: Primary Components GAMETES = Eggs & Sperm FALLOPIAN TUBES UTERUS Steps Involved: Introduction of GAMETES Penetration of the EGG Fertilization of the EGG EMBRYO Transportation of the EMBRYO Implantation of the EMBRYO into the UTERUS

4 INTRODUCTION OF Egg & Sperm CAN OCCUR THROUGH Natural Intercourse (I.C.) Intrauterine Insemination (IUI) Regular/Standard Insemination Micro-manipulation Techniques

5 PENETRATION BY Sperm CAN OCCUR Naturally OR Mechanically

6 FERTILIZATION OCCURS WHEN Genetic Material DNA from a Sperm, combines with that of an Egg and becomes an EMBRYO

7 METHODS OF TRANSPORTING THE EMBRYO TO THE UTERUS 1. Naturally

8 METHODS OF TRANSPORTING THE EMBRYO TO THE UTERUS 2. Mechanically

9 IMPLANTATION OF AN EMBRYO: When an embryo implants in the endometrial lining of the uterus, the patient is PREGNANT!

10 PRIMARY TOPIC OF TONIGHT s SEMINAR Alternative Site of Fertilization

11 SITES OF FERTILIZATION: Fertilization can occur in one of two places: In VIVO ~ Inside the Body In VITRO ~ Outside the Body

12 UNTIL RECENTLY ~ In VIVO = Fallopian Tubes And In VITRO = Laboratory

13 TIMES HAVE CHANGED, and TODAY.. In VIVO = Fallopian Tubes VAGINA

14 TIMES HAVE CHANGED, and TODAY.. In VIVO = Vagina INVOCell

15 INVOCell ~ What is it? The first Intravaginal Culture (IVC) system granted FDA clearance in the U.S. November Device is made of medical grade polystyrene and synthetic rubber latex/thermoplastic elastomer (TPE) with a silicone o-ring. Device is intended to allow for natural incubation of eggs & sperm during fertilization and early embryo development while being retained in the vagina.

16 Really Though. What is INVOCell Offers couples an option in between the current or traditional methods - Intrauterine Insemination (IUI) and In Vitro Fertilization (IVF) Offers couples the ability to fertilize eggs OUTSIDE the tubes but NOT in a laboratory setting. An alternative method of treatment to traditional In Vitro Fertilization (IVF), and is considered a variation of IVF. In essence, it s a step in between IUI and IVF.

17 CLINICAL Differences Between INVOCell and IUI INVOCell Mild ovarian stimulation Eggs are retrieved from the ovaries, then combined with Sperm & placed in INVOCell device. INVOCell device placed inside the woman s vagina acts as the incubator for fertilization to occur. Device is removed (after 3 or 5 days), an embryo is selected and placed in the uterus in hopes of implantation. OI with IUI Very mild ovarian stimulation Prior to ovulation Sperm is placed in a catheter and the woman is inseminated. i.e. Sperm are placed up into the uterine cavity in hopes of one reaching an egg to fertilize and then implant.

18 CLINICAL Differences Between INVOCell and Traditional IVF INVOCell Mild ovarian stimulation Eggs & Sperm placed in INVOCell device. INVOCell device placed inside the woman s vagina acts as the incubator Device removed (after 3 or 5 days) an embryo is selected and placed in the uterus in hopes of implanting. Traditional IVF Aggressive ovarian stimulation Eggs & Sperm placed in a Petri dish. Petri dish placed in Incubator in Embryology LAB. ~24hrs later fertilization is checked. 3 or 5 days later an embryo is selected and placed in the uterus in hopes of implanting

19 INVOCell Procedure & Events

20 Traditional IVF Procedure & Events

21 POTENTIAL ADVANTAGES of INVOCell Decreased exposure to stimulation medications More natural incubation environment. Promotes greater patient involvement psychological benefit. Lowers the cost of fertility treatment with equivalent efficacy and pregnancy rates (compared to traditional IVF). Increases geographic accessibility

22 BEST Candidates for INVOCell? Woman ages 20 to 37 years old Woman having a normal AMH level (2.0 to 2.5) Partner (male) with sperm in the ejaculate Primary fertility issue Tubal Factors (e.g. Prior tubal sterilization procedures; proximally occluded tubes; prior salpingectomies; prior ectopic pregnancies, etc.). BMI < 40 Without a history of Toxic Shock Syndrome; recent pelvic surgery; or recurrent vaginitis

23 Limitations While Device is in Place? Do not bathe in a tub showers are permitted Do not swim Do not use a sauna Do not douche Do not have intercourse Do not perform strenuous activity Do not insert other objects or liquids into the vagina

24 POTENTIAL DISADVANTAGES of INVOCell Preferred patient population group (not for every patient or couple). Results in fewer eggs and subsequent embryos for selection No clinical information about early embryo development may increase risk of abnormal embryos being transferred Not preferred for couple(s) requiring PGS/PGD testing

25 NHC Experience with INVOCell June 2017 to January 2018 Total Cases STARTED: #44 Total Cases COMPLETED: #32 Total Cases NO E.T.: #12

26 INVOCell Cycles No Embryo Transfer AGE Diagnosis Reason CX d Add l Info Group I Group II Group III Group IV 29 Lack of Exposure to Sperm Freeze All for E.T. to Same-Sex Partner Partner + Pregnancy w/fet 23 Lack of Exposure to Sperm Freeze All for E.T. to Same-Sex Partner Pending from FET 34 PCOS / Male Factor / Hypothyroidism Freeze all due to vacation 38 Severe PCOS Poor Follicular Response- No Retrieval Divorced Pending from FET 36 Severe PCOS Poor Follicular Response No Mature Eggs Not Proceeding 27 Tubal Factor / Male Factor No Fertilization w/regular Insem. IVF in April PCOS / Tubal Factor No Fertilization w/regular Insem. Spontaneous Conception 37 PCOS / Tubal Factor No Fertilization w/icsi 2 nd INVO MAB Next IVF 36 ODR / Severe Male Factor Poor Embryo Development (TESE) INVOCell in Apr PCO / Male Factor / Sub- Clinical Hypothyroidism Poor Embryo Development (ICSI) IVF in Apr DOR Poor Embryo Development (Reg Insem) DE 40 DOR / Male Factor Poor Embryo Development (ICSI) Not Proceeding 12 Patients Total

27 PREGNANCY RATES at New Hope Center with INVOCell - COMPLETED CASES June 2017 to January 2018 Good Candidates (22 Patients) Poor Candidates (10 Patients): OVERALL <35yo 35-37yo OVERALL 38-40yo 41yo Per Transfer 16/22 = 73% 11/16 = 69% 5/6 = 83% 2/10 = 20% 2/6 = 33% 0/4 = 0%

28 PREGNANCY RATES at New Hope Center with INVOCell - COMPLETED CASES Good Candidates (22 Patients): Poor Candidates (10 Patients): Per Transfer OVERALL <35yo 35-37yo OVERALL 38-40yo 41yo 16/22 = 73% 11/16 = 69% 5/6 = 83% 2/10 = 20% 2/6 = 33% 0/4 = 0% D3 Transfer 2/2 = 100% 1/1 = 100% 1/1 = 100% 1/5 = 20% 1/2 = 50% 0/3 = 0% D5 Transfer 14/20 = 70% 10/15 = 67% 4/5 = 80% 1/5 = 20% 1/4 = 25% 0/1 = 0% SET (Single Embryo) 9/15 = 60% 7/12 = 58% 2/3 = 67% 1/5 = 20% 1/4 = 25% 0/1 = 0% June 2017 to January 2018

29 COST Difference Per Cycle INVOCell and Traditional IVF INVOCell Total Cost: ~$7,500 to ~$9,000** Traditional IVF Total Cost: ~$13,000 to ~$15,500** **Excludes Fees for Extra Services (if needed) such as: ICSI, AZH, Embryo Cryopreservation **Excludes Fees for Extra Services (if needed) such as: ICSI, AZH, Embryo Cryopreservation, TESE, PGS

30 MAIN PHONE: (757) For Appointment(s): Call or Christel at: Financial Questions: ~ Tammie (or) Suzanne TammieP@thenewhopecenter.com Skernaghan@thenewhopecenter.com

31 Dr. Robin & The New Hope Center THANK YOU for Attending This Evenings Event! MARCH 28, 2018 ~ Next Seminar Same Place ~ Robin s Nest Café Time: Tentatively 6pm (or) 6:30pm Start Topic: LGBT Fertility Treatment Options