New Clinical Study Demonstrates Stork OTC Home Conception Kit is More Effective at Delivering Sperm to the Cervix Than Natural Intercourse When Trying to Get Pregnant

PITTSBURGH–(BUSINESS WIRE)–A new
clinical study
demonstrates that The Stork® OTC is more effective at
delivering sperm to the cervix than natural intercourse when trying to
get pregnant. The peer-reviewed, post-coital sperm assessment study was
performed over a ten-month period by study author Dr. Michael J.
Pelekanos, and is published in the Surgical Technology International,
Issue XXVII. The Stork OTC, the only FDA cleared, over-the-counter home
conception kit using cervical cap insemination, is clinically shown to
deliver a higher concentration of sperm directly to the cervix compared
to natural intercourse1.


The study was an efficacy study designed to compare the number of sperm
in the cervical mucus both with the use of The Stork OTC home conception
kit and natural intercourse. Post-coital test data was collected after
participants used both the Stork OTC home conception kit and the natural
intercourse method to evaluate concentrations of sperm in the cervical
mucus.

The results are promising for the 1 in 6 US couples having difficulty
conceiving with intercourse alone2. “We were very excited to
see the study results confirm that The Stork OTC delivers a
significantly higher sperm concentration to the cervix,” said Stephen
Bollinger, President and CEO of Rinovum® Women’s Health, and Co-Creator
of the device. “With the new data demonstrating the efficacy of the
Stork OTC in aiding conception compared to natural intercourse, couples
trying to get pregnant now have a safe, clinically validated option to
optimize their chances with the Stork OTC.”

The results:

  • In 85% of study subjects, the Stork OTC delivered a 3.23x higher value
    of sperm concentration at the cervix compared to the value of sperm
    concentration with natural intercourse.
  • The remaining 15% of study subjects saw no change in sperm
    concentration between The Stork OTC and natural intercourse.

“Three times the sperm value is quite significant for so many couples,
especially with the growth of male factor infertility,” says Harry
Reich, MD, FACOG, FRCOG. “Understanding the growing value of semen for
successful conception, and having a technology like The Stork®
OTC that can deliver more sperm to the cervix than natural intercourse,
this at-home conception kit may greatly impact many couples on their
path to building a family. The Stork OTC makes sense.”

The kit provides a way for the user to collect, insert and deliver the
sperm directly at the opening of the cervix, and keeps it at the cervix
for longer, giving sperm the opportunity to enter into the uterus.
Considering most sperm never make it through the vaginal tract, the
Stork OTC’s applicator provides a simple and safe way for the user to
bypass the normally unfavorable vaginal environment, to deliver the
sperm. Cervical cap insemination has documented success rates between 10
and 20%3, similar to in-clinic intrauterine insemination
(IUI) success rates (16-21%)4,5.

The Stork OTC is available for purchase at select retailers nationwide,
and online. Visit www.storkotc.com
for online sales and store locations. The device was cleared by the FDA
for over-the-counter sales in July 2014, and made available to the
market in September of 2014. The product is available for sale as The
Stork in the United Kingdom, Australia, and Canada.

About Rinovum® Women’s Health, LLC

Rinovum Women’s Health, LLC is a privately held women’s health
company dedicated to bringing products into the market that will enhance
women’s lives and empower them to take charge of their health. The Stork
Ib2C, Inc., A Rinovum Women’s Health Company, launched its flagship
product, The Stork OTC, which is a conception aid for reproductive
health to assist in natural fertility and conception in the privacy of
the patient’s home. For more information about Rinovum Women’s Health,
The Stork Ib2C, Inc., and The Stork OTC, visit
www.rinovum.com
and
www.storkotc.com.

1 “Postcoital Sperm Assessment Comparative Study.” Michael. J.
Pelekanos, MD. Surgical Technology International, XXVII, November 2015.
2
National Institutes of Health, National Institute of Child Health and
Human Development; http://www.nichd.nih.gov/health/topics/infertility/conditioninfo/Pages/common.aspx
3
”Therapeutic donor insemination: A prospective randomized trial of fresh
versus frozen sperm.” Leslee L. Subak, MD, G. David Adamson, MD, Nancy
L. Boltz, RNC. American Journal of Obstetrics & Gynecology, Volume 166,
Issue 6, Part 1, June 1992. http://www.ncbi.nlm.nih.gov/m/pubmed/1615966/
4
”The cervical cap for home artificial insemination.” Corson SL, Batzer
FR, Otis C, Fee, D. Journal of Reproductive Medicine, May 1986;
31(5)349-52. http://www.ncbi.nlm.nih.gov/m/pubmed/3746786/
5
American Society for Reproductive Medicine: http://www.reproductivefacts.org/FACTSHEET_Intrauterine_Insemination_IUI/

Contacts

Rinovum Women’s Health
Brianna Freeman, 724-241-8936
bfreeman@rinovum.com