Recruiting EARLY_PHASE1 Asherman Syndrome

New treatment option for Asherman Syndrome

Official title Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium

ClinicalTrials.gov ID: NCT05343572

What this study is testing

What is Plerixafor?

Plerixafor is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for asherman syndrome.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study will assess the use of autologous bone marrow stem cells mobilization using 1,1'-[1,4-phenylenebis-(methylene)]-bis-1,4,8,11-tetraazacyclotetradecane (PLERIXAFOR) as an effective medical therapy for the treatment of Asherman's Syndrome (AS), Atrophic Endometrium (AE) and Recurrent Implantation Failure (RIF).
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 40, women only. Healthy volunteers may be eligible.

You may be able to join if

  • Healthy, non pregnant females
  • ages ≥18 and ≤40 years old at time of enrollment
  • with either AS, AE, or RIF
  • For AS: surgical history of intrauterine trauma/infection, hypo/amenorrhea, intra-uterine adhesions
  • for AE: US documentation of persistent, \<6mm endometrial thickness

You likely can't join if

  • Presence of hydrosalpinx (diagnosed by radiographic or ultrasound imaging)
  • Endometriosis (diagnosed by previous surgery,)
  • Diminished ovarian reserve (AMH\ 10)
  • History of genital tuberculosis or any ultrasound evidence of congenital uterine anomaly
  • Submucous or intracavitary fibroid, polyps
  • Currently pregnant
See the full eligibility criteria
Who can join
  • Healthy, non pregnant females
  • ages ≥18 and ≤40 years old at time of enrollment
  • with either AS, AE, or RIF
  • For AS: surgical history of intrauterine trauma/infection, hypo/amenorrhea, intra-uterine adhesions
  • for AE: US documentation of persistent, \<6mm endometrial thickness
  • 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...
What rules you out
  • Presence of hydrosalpinx (diagnosed by radiographic or ultrasound imaging)
  • Endometriosis (diagnosed by previous surgery,)
  • Diminished ovarian reserve (AMH\ 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

The study team makes the final eligibility decision.

Where it's taking place

  • Orange, Connecticut, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Orange, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.