Protocol for "At Home" Study of the Instructions for Use (IFU)
of the Conception Kit.
(Study is currenlty not taking participants)
With only the first month of use reporing, 24% of the participants have become pregnant! Congratulations to the new moms!
Introduction
Problem: When a patient presents claiming difficulty in becoming pregnant, the “Tier One” options for the family care physician are very limited. The Conception Kit is designed to overcome some of the simpler problems of infertility such as:
Motility issues with sperm
Diminished sperm count
Hypospadias and Epispadias
Timing of ovulation
Hostile vaginal environment
Position during Intercourse
Tilted cervix
This is done by: (1) determining the day of the LH Surge; (2) the couple having sex normally using the non-latex semen collector; (3) transferring the semen to the conception cap and, (4) placing the conception cap over the cervix, thereby concentrating the semen at the opening of the cervical os at the optimal time for insemination.
If infertility persists the family care physician may make the decision to prescribe a fertility drug such as Clomid and have the patient continue the use of the Conception Kit.
The Conception Kit will not be able to help conditions of:
Endometriosis
No Sperm in the semen (Azospermia)
Scarred Uterus
Blocked Fallopian Tube
Luteal Phase Defect
Polycystic Ovary Syndrome
Low Amounts of Follicle Stimulating Hormone
Cervical Stenosis
Genital Warts
Age
Polyps and Fibroids
Other Serious Conditions.
Objectives
All components of the Conception Kit including the Conception Cap have 510K clearance for their individual indications. The objective is to determine if patients can successfully follow the instructions that accompany the Conception Kit and complete the sequence of tasks that would result in semen placed at the end of the cervix at ovulation.
Methodology
Protocol for “at home” study.
Number of patients to be enrolled: More than 30 (although the results from the first 30 patients will accompany 510K application, the additional patient information will be kept by the company for future use.)
Inclusion Criteria:
Women to be enrolled in this study will be :
- actively seeking pregnancy
- willing to sign informed consent acknowledging their wish to become pregnant
- agree to fill out and return a short questionnaire
Brief Description:
Patient will consult with a doctor to determine if the Conception Kit is appropriate and will receive a full explanation of the study, including risks and benefits, etc. Patient will execute the informed consent. Patient will then use the Conception Kit in her home following the instructions included in the kit as well as having access to the information on the web site. After the first use, the patient will then fill in the questionnaire and return the questionnaire to the Conceivex Company in a stamped self addressed envelope.
Success will be defined as the woman being able to demonstrate her knowledge of the process by correctly responding (defined as correct responses to 75% of questions) to Part I of the attached questionnaire. The attainment of a successful pregnancy will not be required as the patient may have a condition that the kit may not be able to help.
Supplies needed:
Conception Kits
Informed Consent Forms
Doctor Kits (i.e., demo caps and Instruction Books)
Questionnaires
Stamped Self addressed envelopes |
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