Clinical trial Recruiting at 1 site Early Phase 1 Interventional Ages 18 to 40 Women only

Using bone marrow stem cells to treat abnormal endometrium conditions

Official title: Bone Marrow Derived Stem Cells Mobilization for Treatment of Asherman's Syndrome, Atrophic Endometrium, and Recurrent Implantation Failure

Run by Yale University · NCT05343572 · Data updated 2026-11-12

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

PhaseEarly Phase 1
Study typeInterventional
Ages18 Years to 40 Years
SexWomen only
Enrollment90 (estimated)
SponsorYale University
Academic / other
Locations1 site (Orange, Connecticut)
StatusRecruiting
StartedNovember 1, 2023
Main results expectedDecember 2026
Study endsDecember 2027
Registry record updatedNovember 12, 2025
Trial IDNCT05343572 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are healthy, non-pregnant females aged 18 to 40 with Asherman's Syndrome, Atrophic Endometrium, or Recurrent Implantation Failure.

Probably not a fit

Patients with conditions such as hydrosalpinx, endometriosis, or diminished ovarian reserve may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Potential benefit: If successful, this approach could improve pregnancy outcomes for women suffering from these reproductive conditions.

How similar studies have gone: 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.

Who can join: the full rules

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 it's running

  • Yale Fertility Center
    Orange, Connecticut, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.