What technology does the product compete with or replace?
The Stork by Rinovum Women’s Health helps bridge the gap between natural intercourse and more costly, in-clinic treatments, like IUI or IVF. The Stork utilises cervical cap insemination, giving couples the ability to use this technique in the privacy of home. It is a more natural first-step in assisted reproductive treatments for a couple who is not ready to take the next step of IUI or IVF. The Stork can be used in conjunction with other ovulation/fertility monitor products or on its own to improve the chances of conception.
Who should use The Stork?
- People that are trying to become pregnant.
- Men diagnosed with low sperm count or motility issues.
- Patients trying to become pregnant without intercourse.
- Patients who desire to control timing.
- Patients who are not ready to take the next step to in-clinic reproductive treatment options (i.e. IUI, IVF).
What are the indications for use?
The Stork is indicated for home use assisted insemination by couples who are trying to become pregnant. The Stork contains a cervical cap inside a condom-like silicone sheath and an applicator. It is used to collect semen into a cervical cap then deliver it outside of the cervix as an aid to conception. The Stork cervical cap should not be left in place for longer than six hours.
What is a cervical cap?
Historically, cervical caps have been used for both conception and contraception dating back to the 1950’s. Doctors used cervical caps for insemination with great success rates (see journal articles below). The Stork brings back that technique adding a special applicator to improve the delivery method of the cervical cap to the cervical opening.
Are there any known complications or adverse reactions with using the device?
There were no complications found during clinical studies. There are no publications that discuss whether cap usage can cause TSS (toxic shock syndrome). The instructions for use instruct the patient to remove the cap four to six hours after insertion to reduce the risk of TSS.
Is there any chance for contamination during packaging?
The product is non-sterile. The product is packaged in a medical clean room. To avoid contamination, customers are advised not to open or handle the device until they are ready to use it.
Are there any health conditions that prevent patients from using this device?
Do not use this device if you have been advised that it may be medically unsafe for you to engage in sexual intercourse or become pregnant.
What is the recommended amount of time that a patient should use The Stork?
Three to six months of use on the female patient’s three most fertile days of her cycle. After six months of use, the patients are advised to speak with their physician about another treatment option.
Can the device be reused?
No, each device is designed for single-use only.
Can The Stork be used while on fertility medications?
Yes, there are currently no contraindications for the use of fertility medications and cervical cap insemination.
How long after placing the cervical cap does the user have to wait before returning to normal activities?
The patient can return to normal activities immediately after placing the cervical cap and removing the applicator. Patients should not have sexual intercourse while the cervical cap is inserted as it may cause discomfort. The patient is instructed to remove the cervical cap four to six hours after placing the cap.
If there is an adverse event whom do I contact?
Ceuta Healthcare Customer Services Hill House
41 Richmond Hill
0844 243 6661