Actively Recruiting

Early Phase 1
Age: 18Years - 40Years
FEMALE
Healthy Volunteers
ID05343572

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

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

90

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying autologous bone marrow stem cell mobilization using the drug Plerixafor to treat women with Asherman's 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 Asherman's 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 treatment's 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

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day intervention with effects monitored over several months

Participants receive a single subcutaneous dose of PLERIXAFOR the evening before scheduled surgery for mobilization of bone marrow stem cells as part of their treatment.

1 treatment visit (in-person)

Follow-up

Duration - Up to 24 months

Participants are monitored for changes in endometrial thickness, implantation rates, and pregnancy outcomes with assessments at 3 and 6 months following treatment.

Visits approximately every 3 months for up to 24 months

Trial Site Locations

Total: 1 location

1

Yale Fertility Center

Orange, Connecticut, United States, 06477

Actively Recruiting

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Research Team

H

Hugh S Taylor, MD

M

Michele Frank, BSN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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