Intrauterine Adhesions: Understanding Asherman’s Syndrome and the Rejoni Clinical Trial

Intrauterine adhesions (IUAs), also known as Asherman’s Syndrome, represent one of the most undiagnosed health issues affecting women in the United States today. They result from traumatic damage to the endometrium—the lining of the uterus—often due to surgical procedures. This condition can lead to serious reproductive health concerns, including fertility challenges and other medical complications. Fortunately, recent advancements in medical research, especially the new Rejoni clinical trial, show promise in preventing these adhesions from forming.

What Are Intrauterine Adhesions?

The uterus is lined with a specialized tissue called the endometrium, which plays a crucial role in pregnancy. When a pregnancy does not occur, the endometrial lining is shed during menstruation. However, any injury to this delicate tissue—often from uterine procedures like dilation and curettage (D&C) or hysteroscopy—can culminate in scar tissue formation, leading to intrauterine adhesions. These adhesions can manifest as thin bands of scar tissue or more substantial bands that potentially block the uterine cavity, resulting in a diagnosis of Asherman’s Syndrome.

Asherman’s Syndrome can arise following uterine surgeries or other procedures, and it might cause significant fertility issues, highlighting the need for specialized gynecology services for proper diagnosis and management.

The condition has two types of adhesions: primary and secondary. Primary adhesions can develop post-pregnancy loss or during surgeries for fibroid removal. Secondary adhesions may appear after surgical removal of existing ones, leading to recurrence. Some women may remain asymptomatic, while others may exhibit various debilitating symptoms.

How Does the Rejoni Clinical Study Work?

Rejoni, Inc., a research-focused company based in Bedford, MA, is conducting an innovative clinical trial aiming to test an advanced hydrogel, Juveena™ Hydrogel, as a method to prevent intrauterine adhesions. Women scheduled for surgery to address existing adhesions or to remove fibroids may be eligible for the study.

Participants will be randomly assigned to two groups: the treatment group, receiving the hydrogel immediately after surgery, or a control group without the hydrogel. Notably, two participants will be allocated to the treatment group for every individual in the control group, enhancing the chances of receiving the hydrogel for those who qualify. Interested individuals are encouraged to contact Arizona Gynecology Consultants to explore their eligibility for this groundbreaking research.

Am I a Candidate For This Clinical Study?

Women with a history of intrauterine adhesions are prime candidates for the Rejoni clinical study. If you are at least 18 years old and have been diagnosed with a condition requiring fibroid removal or adhesiolysis, you may qualify for participation. Enrollment in this trial comes free of charge, and candidates not only contribute to expanding medical knowledge but also gain access to potentially transformative treatment options.

Before enrolling, participants will be provided with comprehensive information regarding study procedures, and all questions will be answered to ensure informed consent.

What Causes Intrauterine Adhesions?

Intrauterine adhesions primarily arise post-surgery in the uterus. Common causes include:

• Dilation and curettage (D&C): This outpatient procedure often aims to diagnose or treat complications associated with uterine bleeding or miscarriages but can inadvertently lead to scarring.
• Surgical removal of fibroids: Procedures such as myomectomy, especially when involving the endometrial lining, can create scar tissue.
• Endometritis or infections: Conditions like endometritis or postpartum infections can increase the risk of adhesion formation.
• Incorrect placement or prolonged use of an IUD: Such scenarios can damage the uterine lining and elevate adhesion risk.

Understanding these causes assists healthcare providers in identifying women at risk of developing adhesions post-procedure.

What Are the Symptoms of Intrauterine Adhesions?

The symptoms of intrauterine adhesions range widely, with some women experiencing none at all. Common symptoms associated with Asherman’s Syndrome include:

• Menstrual abnormalities, including light or infrequent periods
• Inability to achieve pregnancy or recurrent miscarriages
• Birth complications, such as abnormal implantation of the placenta
• Pelvic pain or painful menstrual periods

Women experiencing these symptoms should seek specialized care at Arizona Gynecology Consultants to receive appropriate evaluations and treatment options.

How Are Intrauterine Adhesions Diagnosed?

Diagnosis of Asherman’s Syndrome typically involves procedures like hysterosalpingogram, hysteroscopy, or saline sonohysterogram. Hysteroscopy is especially effective, allowing a physician to visualize the uterine cavity through a lighted telescope equipped with a camera. Imaging techniques may involve the use of dyes or saline to expand the uterine cavity, thereby revealing any blockages.

These diagnostic procedures are often minimally invasive and might not require general anesthesia, although discomfort management strategies are generally provided for post-procedural care.

Who Is at Risk For Intrauterine Adhesions?

Several risk factors can elevate the likelihood of developing intrauterine adhesions, including:

• Previous uterine surgeries resulting from miscarriage or cesarean sections
• Repeated miscarriages
• Advanced maternal age
• Conditions that lead to prolonged uterine bleeding

Awareness of these risk factors can guide healthcare professionals in preventative approaches or necessary treatments for at-risk women.

Common Treatments For Intrauterine Adhesions

Once diagnosed, patients with intrauterine adhesions are often recommended surgical intervention. The most common approach involves hysteroscopy for adhesiolysis, where excess scar tissue is meticulously removed under anesthesia. In some cases, doctors may place a device post-surgery to keep the uterine walls apart, thus minimizing the risk of adhesion recurrence.

Additionally, hormone therapy, along with nonsteroidal anti-inflammatory drugs (NSAIDs) or antibiotics, may be utilized to prevent the reformation of adhesions.

Are There Risks Associated With Treating Intrauterine Adhesions?

While treatment for intrauterine adhesions aims to restore normal uterine function, there are potential risks, especially related to future pregnancies. Possible complications may include miscarriage, preterm labor, and other placental abnormalities. Women are encouraged to discuss these implications with their healthcare providers.

A promising aspect of the Rejoni clinical trial is its potential to intervene at the point of surgery, possibly preventing the reformation of adhesions, thereby offering new hope for women affected by Asherman’s Syndrome.

Rejoni Clinical Trial FAQs

As a potential participant, you may have several questions regarding the Rejoni clinical trial. Here are responses to some frequently asked questions:

What Is Adhesiolysis?
Adhesiolysis is the surgical procedure performed to treat intrauterine adhesions. It involves carefully cutting and removing scar tissue under general anesthesia, typically employing a hysteroscope to visualize the procedure.

Who May Participate in the Rejoni Clinical Trial?
Eligibility criteria include being 18 years or older and having a history of intrauterine adhesions or requiring fibroid removal or adhesiolysis. Women without such histories may not qualify for this specific study.

What Happens in the Treatment Group?
This group will receive Juveena™ Hydrogel after adhesion removal surgery. The trial aims to evaluate whether this gel reduces the recurrence of adhesions.

What Are the Benefits of Participation?
Participation may lead to receiving advanced treatment that could reduce the risk of adhesions returning—a significant factor in maintaining fertility.

How Do I Sign Up?
Begin the process by consulting with one of our physicians at Arizona Gynecology Consultants to determine your candidacy. Upon qualifying, we will guide you through the participation process.

Contact Arizona Gynecology Consultants to See If You Are a Clinical Trial Candidate

If you have a history of intrauterine adhesions and meet the age criteria, you could be an excellent candidate for the Rejoni clinical trial. Arizona Gynecology Consultants continuously pursues and stays abreast of the latest clinical studies related to women’s health. We recommend studies that can offer safe and effective treatment options for our patients.

Participation in clinical trials contributes significantly to medical research, fostering advancements in treatment that can positively impact many women’s lives. To determine if you qualify for the Rejoni clinical trial, please contact our office today.

Sources:

1. Parashar, S., Pajai, S., & Tarang, T. (n.d.). Recent Advancement in the Management of Intrauterine Adhesions Using Stem Cell Therapy: A Review Article. Cureus, 15(8), e43553. DOI:10.7759/cureus.43553
2. Smikle, C., Yarrarapu, S. N. S., & Khetarpal, S. (2022). Asherman Syndrome. PubMed; StatPearls Publishing. NCBI Books

Dr. Kelly Roy, the founder and medical director at Arizona Gynecology Consultants, specializes in surgical gynecology and advanced laparoscopy. A committed advocate for women’s healthcare, Dr. Roy continues to contribute to the field through teaching and research. For more about her qualifications and expertise, visit Dr. Kelly Roy’s profile.