Who may be eligible for this Asherman's Syndrome clinical trial?

Women aged 18 to 40 years with a diagnosis of Asherman's Syndrome, Atrophic Endometrium, or Recurrent Implantation Failure may be eligible. Participants must be healthy, non-pregnant females without certain conditions like hydrosalpinx or endometriosis. Please review eligibility criteria for more details.

Is there any cost to participate in this Asherman's Syndrome clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Early Phase 1

Age: 18Years - 40Years

FEMALE

Healthy Volunteers

ID05343572

Using Plerixafor to Mobilize Bone Marrow Stem Cells for Treating Ashermans Syndrome, Thin Endometrium, and Recurrent Implantation Failure in Women Aged 18 to 40

Q: What is Plerixafor studying for Asherman's Syndrome, Atrophic Endometrium, and Recurrent Implantation Failure?

Plerixafor is being studied to see if it can help restore the lining of the uterus and improve pregnancy chances in women with these conditions. The study compares this treatment to standard therapies, aiming to improve endometrial thickness and implantation rates. The research is led by Hugh Taylor.

Led by Hugh Taylor · Updated on 2025-11-12

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying autologous bone marrow stem cell mobilization using the drug Plerixafor to treat women with Ashermans Syndrome, Atrophic Endometrium, and Recurrent Implantation Failure. The goal is to evaluate if Plerixafor can restore endometrial function and improve pregnancy implantation rates compared to standard treatments. This early phase 1 study involves women aged 18 to 40 years with specific diagnoses related to these conditions. The study involves a single subcutaneous dose of 20 mg Plerixafor administered the evening before scheduled standard care surgery for participants. Those weighing over 83 kilograms receive a weight-based dose of 0.24 mg per kilogram. Participants are grouped by their condition refractory Ashermans Syndrome, atrophic endometrium with thin lining, or recurrent implantation failure despite multiple embryo transfers. They will be monitored for changes in endometrial thickness and pregnancy outcomes over time. Participants will be asked to avoid NSAIDs two weeks before and 30 days after treatment and to abstain from intercourse for three months following administration. Assessments will include menstrual bleeding patterns, endometrial blood flow, and histology before treatment and at 3 and 6 months after. Researchers will track implantation rates and pregnancy outcomes every three to six months up to 24 months, with ongoing monitoring to evaluate the treatments impact and safety.

CONDITIONS

Brief Title

Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium

Who Can Participate

Age: 18Years - 40Years

FEMALE

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Healthy, non-pregnant females
Age between 18 and 40 years at enrollment
Diagnosis of Asherman's Syndrome, Atrophic Endometrium, or Recurrent Implantation Failure
For Asherman's Syndrome: history of intrauterine trauma or infection, hypo/amenorrhea, and intra-uterine adhesions
For Atrophic Endometrium: ultrasound showing persistent endometrial thickness less than 6 mm
For Recurrent Implantation Failure: failure to achieve clinical pregnancy after transfer of at least four good-quality embryos in at least three fresh or frozen cycles
Currently receiving treatment at Yale Fertility Clinic

You will not qualify if you...

Presence of hydrosalpinx diagnosed by imaging
History or diagnosis of endometriosis
Diminished ovarian reserve (AMH less than 1 ng/ml or FSH greater than 10)
History of genital tuberculosis or congenital uterine anomaly
Presence of submucous or intracavitary fibroids or polyps
Currently pregnant
Personal history of thrombophilia or sickle cell disease
Unable to provide informed consent

Research Team

Hugh S Taylor, MD

Michele Frank, BSN

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