First Report- DITM Creator Discovers New Cause of Infertility, Company Producing Device for Bleeding

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This is another exciting first for DITM. I previously posted about my award winning research presented on the development of autofluorescent laparoscopy. Now here is information about my latest research just presented at the AAGL 35th Global International Congress on Gyn Endoscopy.

The study was the first human clinical and primate data supporting the development of a new surgical device to treat abnormal uterine bleeding (AUB) It also describes what would be a new form of uterine infertility that forms the basis for the device development. The study consisted of a human clinical case series of women with a rare form of “Asherman’s Syndrome” or intrauterine scarring and a non-human macaque primate model designed to replicate this disease for the first time.

This study represents an amazing opportunity to help women. We have uncovered a potential new form of uterine infertility that would be missed by traditional diagnostic methods. While I am working to cure this uterine condition, A start-up medical company is working to develop these discoveries into a treatment to help women with excessive bleeding. Their device is in human feasibility clinical trials.

Current surgical treatments are primitive because they destroy the entire uterus to stop bleeding. This would represent the first treatment confined to a tiny portion of the uterus that causes it to simply and reversibly shut its own function off.  For the diseae of Asherman’s Syndrome this is an important opportunity to better understand what is happening to help cure women with the disease. 

In Asherman’s Syndrome, scar tissue forms inside the uterus causing cessation of menstrual bleeding and infertility. It has been believed that the cessation of bleeding is directly due to the scar tissue damaging the normal endometrial lining tissue. I have a large international referral practice of difficult cases of Asherman’s Syndrome and observed that a subset of women with the disorder has a relatively small amount of scarring confined to the opening of the uterus inside the cervix that reflexively causes menses to stop.  What was so interesting is that traditional theories say that when the flow of menses out of the uterus is blocked the uterus will fill up with blood- called a hematometria.  We found this is not the case at all in this situation.  In fact the opposite occurs.  The uterus downregulates its lining which “shuts itself off”.  The lining become thin and atrophic.  We are conducting further studies to define the mechanism by which this occurs. 

The clinical findings support the discovery of a new cause of the cessation of menses. There is potentially a milder form of the disorder that would lead to infertility or miscarriage. Any partial impediment to blood flowing freely out of the uterus could lead to a mild form of the uterus shutting itself off.

Noninvasive ultrasound imaging followed by hysteroscopic examination and correction of scarring demonstrated that the entire upper functional portion of the uterine fundus was normal and that the scar was confined to the lower cervical opening only.

We also presented data from a non-human primate study designed to replicate these findings. Monkeys were treated with hormones (estradiol and progesterone) to induce artificial menstrual cycles. The animals underwent focal surgical attachment of the inner uterine surfaces just above the cervix to partially close the uterus.   The uterus was then examined after 5 menstrual cycles.  The amount of menstruation was recorded and endometrial thickness under the microscope. Menstrual bleeding reduced 77% with some animals having complete absence of menstruation. Endometrial thickness was also significantly reduced.  The findings exactly matched out human cases with the disease!

Why This is Significant:

1)  Even women who seem “normal” may suffer from a mild form of this newly-discovered cause of infertility

2) This is the first discovery of a disease where the human reproductive system “shuts itself off” in response to an injury

3)  Abnormal heavy menstrual bleeding is a huge problem for women worldwide leading to D&C’s and hysterectomies.  A company is working to make the shut off condition into a reversible treatment.  This would be the first nondestructive treatment for heavy uterine bleeding.

Thanks to my coauthors on the study: Jim Coad, MD of the Department of Pathology West Virginia University Medical School and Ov Slayden PhD at the Oregon National Primate Regional Center/Oregon Health Sciences University.

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