1. Pregnancy and Ovulation Test Kits Dr. Ed Randell

2. The female reproductive Cycle What happens at the Pituitary What happens at the ovaries What happens at the uterus What happens to the hormones

3. What happens at the pituitary

4. Hypothalamus Anterior Pituitary Ovary Uterus GnRH FSH/LH Estrogen And Progesterone Positive feedback On days 12 to 14 Negative feedback Over most of cycle

5. Anatomy of the female reproductive system.

6. What happens at the ovaries

7. What happens at the Uterus

8. What happens to the hormones

9. The Menstrual Cycle

10. Fertilization and Implantaton Implantation of blastocyst Day 7 Fertilization Day 4 Day 3 Day 2 Day 1 Day 0 Egg released by ovary (DAY 0) Uterine wall Blastocyst Morula 4 cells2 cells Zygote Ovary Fallopian tube

11. Home Pregnancy Test Kits Measure Urinary human Chorionic gonadotropin (hCG) levels. Can detect urinary hCG as low as 25IU Maximum Sensitivity: 1 to 4 days post MMP Reason for use Detects pregnancy at very early stage Earlier prenatal care

12. How the Test Works First introduced in 1976 Hemagglutination inhibition Earliest Sensitivity 4 days post-MMP Most recent methods Use monoclonal antibodies Much more sensitive ~ day of MMP Accuracy quoted >98% Various Formats: test stick, test well, test solution, colored line Time involved and # of Steps vary

13. Latex Agglutination

14. Home Pregnancy Test Kits Strip Dip Cassette

15. Home Pregnancy Test Kits

16. Completion of the test Supplies Kit Pipette Urine

17. Completion of the test Steps Add 3 drops of urine into sample well Wait

18. Completion of the test Interpret Results

19. 1 st hCG specific antibodies 2 nd hCG-specific antibodies Sample window Antibody against Antibody to hCG Home Pregnancy Test Kits

20. hCG Home Pregnancy Test Kits

21. Positive Test Negative Test Home Pregnancy Test Kits

22. Patient Consultation 1) 1st AM voiding; > conc. of HCG 2) Run test immediately, or store sample in refrig. 1) use within 24 hrs; 2) allow to come to room temp. 3) Follow timing and sequence of steps. 4) If negative, repeat in 7 days. See MD regardless of result If negative - may require amenorrhea workup If positive - will need prenatal care follow-up.

23. Interpretation Negative Result HCG is not present at detectable concentrations Positive Result Pregnancy False Positives Drugs: Antiparkinsonian, anticonvulsants, phenothiazines. Medical Conditions: Tumors, Recent completed pregnancy or miscarriage. False Negatives Testing too early, Urine not at room temp.

24. Accuracy 97% sensitivity In 100 pregnant women 97 will be positive 3 false-negative. 95% specificity In 100 non-pregnant women 95 will be negative 5 false-positives. Accuracy similar to laboratory tests. User and technique dependent.

25. Home Pregnancy Test Kits

26. Predicting Ovulation Pattern of Menstrual Cycle with Calendar Cervical Mucous BBT LH Surge

27. Detecting Ovulation Measures Urinary LH Best indicator is 50%  over mean basal plasma LH  in urine follows. Ovulation usually within 12-24 hours. (Basal body temp change follows ovulation)

28. How the Test Works LH increases sharply prior to Ovulation “LH Surge” Causes ovarian follicle rupture and release of mature egg within in 1 to 2 days. Occurs 8 to 12 hrs later in urine ~6 consecutive days of testing will detect LH Surge in about 66% of ovulating women ~10 consecutive days of testing increase probability to 95%. Intensity of color on test strip is proportional to LH in Urine

29. Kit Comparison

30. Ovulation Prediction Kits

31. Monitor device Measure LH and E3G E3G indicates when to start testing for LH Gives readout according to fertility Low High-E3G detected Peak-LH and E3G detected

32. The Menstrual Cycle

33. Monitor device

34. General Procedure 1. Calculate cycle length of 3 most recent menstrual periods. 2. Calculated average cycle length determines day to start testing. 1. Begin testing 2-3 days before expected ovulation 3. Urine collection is product dependent :follow specific instructions.

35. Precautions Timing Sample Storage before testing LH surge not detected Test not performed properly Ovulation did not occur Testing begun to late

36. Factors influencing Results