Using bone marrow stem cells to treat abnormal endometrium conditions
Bone Marrow Derived Stem Cells Mobilization for Treatment of Asherman's Syndrome, Atrophic Endometrium, and Recurrent Implantation Failure
EARLY_PHASE1 · Yale University · NCT05343572
This study is testing if using a special treatment to help bone marrow stem cells can improve conditions like Asherman's Syndrome and help women get pregnant better than standard care.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Yale University (other) |
| Locations | 1 site (Orange, Connecticut) |
| Trial ID | NCT05343572 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of mobilizing autologous bone marrow stem cells using Plerixafor for treating Asherman's Syndrome, Atrophic Endometrium, and Recurrent Implantation Failure. Participants will undergo treatment and their endometrial thickness and implantation rates will be compared to historic controls receiving standard care. The study also aims to assess ongoing pregnancy and live birth rates, as well as changes in menstrual bleeding patterns and endometrial blood flow over time.
Who should consider this trial
Good fit: Ideal candidates are healthy, non-pregnant females aged 18 to 40 with Asherman's Syndrome, Atrophic Endometrium, or Recurrent Implantation Failure.
Not a fit: Patients with conditions such as hydrosalpinx, endometriosis, or diminished ovarian reserve may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve pregnancy outcomes for women suffering from these reproductive conditions.
How similar studies have performed: While the use of stem cells in reproductive medicine is an emerging field, this specific approach using Plerixafor for these conditions is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy, non pregnant females * ages ≥18 and ≤40 years old at time of enrollment * with either AS, AE, or RIF 1. For AS: surgical history of intrauterine trauma/infection, hypo/amenorrhea, intra-uterine adhesions 2. for AE: US documentation of persistent, \<6mm endometrial thickness 3. for RIF: failure to achieve a clinical pregnancy after transfer of at least four good-quality embryos in a minimum of three fresh or frozen cycles in a woman under 40 years and currently being treated at Yale Fertility Clinic Exclusion Criteria: * Presence of hydrosalpinx (diagnosed by radiographic or ultrasound imaging) * Endometriosis (diagnosed by previous surgery,) * Diminished ovarian reserve (AMH\<1ng/ml or follicle stimulating hormone (FSH)\>10) * History of genital tuberculosis or any ultrasound evidence of congenital uterine anomaly * Submucous or intracavitary fibroid, polyps * Currently pregnant * Personal history of thrombophilia or sickle cell disease * Inability to provide informed consent
Where this trial is running
Orange, Connecticut
- Yale Fertility Center — Orange, Connecticut, United States (RECRUITING)
Study contacts
- Principal investigator: Hugh Taylor, MD — Yale University
- Study coordinator: Hugh S Taylor, MD
- Email: hugh.taylor@yale.edu
- Phone: (203)-785-6949
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Asherman Syndrome, Atrophic Endometrium, Recurrent Implantation Failure, bone marrow derived stem cells