Recruiting NCT05343572

Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium

Early Phase I Interventional Asherman Syndrome Atrophic Endometrium Recurrent Implantation Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Plerixafor.
Who it may be relevant to: Registry conditions: Asherman Syndrome, Atrophic Endometrium, Recurrent Implantation Failure. Basic parameters: 18 years — 40 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Detailed description

Primary Objective:

* To compare endometrial thickness and implantation rates in women with AS, AE, and RIF receiving PLERIXAFOR compared to historic controls that received existing standard of care therapy * To compare ongoing pregnancy and live birth rates in women with AS, AE, and RIF receiving PLERIXAFOR compared to historic controls that received existing standard of care therapy

Secondary Objectives: (assessed in participants who have not achieved pregnancy as of the timepoint):

\- Endometrial thickness prior to treatment with PLERIXAFOR compared to endometrial thickness 3 and 6 months after treatment.

During this study, participants are asked to:

* Refrain from use of non-steroidal anti-inflammatory drugs (NSAIDs) from 2 weeks prior to the start of the surgery/PLERIXAFOR administration, and for the 30 days following surgery/ PLERIXAFOR administration. * Abstain from intercourse for three months following surgery/PLERIXAFOR administration

* Assessment of menstrual bleeding pattern before and 3 and 6 months following treatment with PLERIXAFOR * Assessment of endometrial blood flow before and 3 and 6 months following treatment with PLERIXAFOR * Assessment of endometrial histology three months following treatment with PLERIXAFOR The study intervention consists of administration of PLERIXAFOR the evening prior to scheduled standard of care surgery for women with AS, AE or RIF, for peripheral mobilization of stem cells. PLERIXAFOR is administered via the subcutaneous route, as a single dose of 20mg.

The goal of this study is to determine if the administration of PLERIXAFOR for autologous, peripheral stem cell mobilization and administration will restore endometrial function in women with AS, AE, and RIF, and allow for pregnancy implantation.

Interventions

Drug Plerixafor
A 20mg single dose of PLERIXAFOR is administered subcutaneously the evening prior to scheduled standard of care surgery for women with AS, AE or RIF for peripheral mobilization of stem cells. For subjects weighing \>83 kilogram, the dosing is a single dose of 0.24 milligram per kilogram.

Primary outcome measures

Change in endometrial thickness and implantation rates following treatment with Plerixafor at 6 month intervals up to 24 months, compared to controls [Time frame: Every 6 months from baseline up to 24 months]

Secondary outcome measures (3)

Change in endometrial thickness and implantation rates with Plerixafor in women with AS, AE and RIF at 3 month intervals, compared to baseline/pre-treatment [Time frame: Every 3 months from baseline up to 24 months]
Difference in ongoing pregnancy and live birth rates in women with AS, AE and RIF following treatment with Plerixafor at 3 month intervals, compared to baseline/pre-treatment [Time frame: Every 3 months from baseline up to 24 months]
Change in endometrial thickness from baseline after treatment with Plerixafor at month 3 and month 6 for participants that have not achieved pregnancy as of the timepoint [Time frame: baseline, month 3 and month 6]

Eligibility criteria

Inclusion criteria

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 1 center

Yale Fertility Center — Orange

Identifiers

NCT: NCT05343572 · 2000026217 · No NIH funding

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗