The following Questionaire was use for At-Home Kit Study
(study is currently closed to new participants)
With only the first month of use reporing, 24% of the participants have become pregnant! Congratulations to the new moms!
Section One - Questions about the Instructions
1. The best time to have intercourse to become pregnant is:
a. The day of the LH Surge
b. The day after the LH Surge
c. The day before the LH Surge
2. Soap is a spermicide?
a. True
b. False
3. The normal density or consistency of semen is:
a. Watery
b. Viscous (ie. thick like gelatin)
c. Both: watery and viscous are both normal in the same man within a short period of time.
4. The Conception Cap should be left in place for:
a. 6 to 8 days
b. 36 hours
c. 6 to 8 hours
5. Correct use of the Conception Cap call for the woman laying down with her elevated after insertion of the Conception Cap.
a. True
b. False
6. The Conception Cap will not protect a woman from a Sexually Transmitted Disease (STD).
a. True
b. False
7. The Conception Kit can not help a woman with a blocked fallopian tube or a badly scarred uterus.
a. True
b. False
8. The Conception Kit can help any type of infertility problem.
a. True
b. False
9. Choose the correct statement about reuse of the Conception Cap.
a. The Conception Cap can be used any number of times.
b. The Conception Cap cannot be reused because of a risk of contamination or soap residue killing the sperm.
c. The Conception Cap can be reused because there is a chance that there maybe a sperm left alive from the last time.
10. The Conception Cap can be shared with another person?
a. True
b. False
11. Proper disposal of the Conception Cap means
a. Placing the Conception Cap back in the tray before throwing it away.
b. Burning the Conception Cap
c. Putting the Conception Cap through a paper shredder.
Section Two: Use of the Conception Kit
12. How would you describe the user instructions?
1. Very easy
2. Easy
3. Medium
4. Difficult
5. Very Difficult
13. What additional information, if any, would have been helpful to add to the written instructions?
___________________________________________________________
14. Did you use the web site?
a. Yes
b. No
15. How would you describe the difficulty in transferring the semen from the Semen Collector to the Conception Cap?
a. Very easy
b. Easy
c. Medium
d. Difficult
e. Very difficult
16. Did the Semen Collector tear or break?
a. Yes
b. No
17. How would you describe the insertion of the Conception Cap?
a. Very easy
b. Easy
c. Medium
d. Difficult
e. Very difficult
18. Were you able to get the Conception Cap in place without spilling the semen?
a. Yes
b. No
19. Did you or your partner/husband insert the Conception Cap?
a. I did
b. My partner/husband did
c. We both did
20. How long did you leave the Conception Cap in place? __________
21. After you put the Conception Cap in place, did it move or dislodge so that you had to re-insert or put it back into place?
a. Yes
b. No
22. How would you describe removing the Conception Cap?
a. Very easy
b. Easy
c. Medium
e. Difficult
f. Very Difficult
23. How confident are you that you understood and followed the instructions?
a. Very confident
b. Confident
c. Not sure
d. Not confident
______________________________________________
This information has be forwarded to the FDA for evaluation of the Instructions for Use of the Conception Kit. |
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