Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium

Early Phase 1

Recruiting

• Conditions: Asherman Syndrome; Atrophic Endometrium; Recurrent Implantation Failure
• Interventions: Drug: Plerixafor

• Registration Number: NCT05343572
• Lead Sponsor: Hugh Taylor

Brief Summary

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

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).

Primary Objective:
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-25
• Study Start: 2023-11-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endometrial Disorders	Plerixafor	Three groups of patients, with 10 subjects per group: 1. Asherman's syndrome, as classified by the American Society of Reproductive Medicine (ASRM) by extent of uterine cavity involvement and adhesion type. Specifically, refractory Asherman's syndrome: patients who have had at least one operative hysteroscopy which was unsuccessful. 2. Atrophic endometrium, as defined by maximal endometrial lining thickness ≤6mm documented in at least 2 cycles on either: * Day of luteinizing hormone (LH) surge in natural cycle * Day of human chorionic gonadotropin (hCG) trigger in the setting of fresh IVF cycle * Day 14 of estradiol in the setting of frozen embryo transfer things (FET) cycles 3. Recurrent implantation failure, defined as failure to achieve a clinical pregnancy after transfer of at least four good-quality embryos in a minimum of three fresh or frozen transfer cycles in a woman under 40 years

Primary Outcome Measures

Name	Time	Method
Change in endometrial thickness and implantation rates following treatment with Plerixafor at 6 month intervals up to 24 months, compared to controls	Every 6 months from baseline up to 24 months	Change in endometrial thickness post treatment compared to historic controls that received existing standard of care therapy, measured using ultrasound. Thicker endometrium (\>6mm) indicates restoration of endometrial function.

Secondary Outcome Measures

Name	Time	Method
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	Every 3 months from baseline up to 24 months	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 will be assessed. Less atrophy, less fibrosis, greater blood vessel formation and greater endometrial blood flow on ultrasound, compared to historic controls is indicative of restoration of endometrial f...
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	baseline, month 3 and month 6	Change in endometrial thickness from baseline after treatment with Plerixafor compared to month 3 and month 6 measured using ultrasound. Thicker endometrium (\>6mm) indicates restoration of endometrial function.
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	Every 3 months from baseline up to 24 months	The 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 will be assessed. Less atrophy, less fibrosis, greater blood vessel formation and greater endometrial blood flow on ultrasound, compared to historic controls is indicative of restor...

Trial Locations

Locations (1)

Yale Fertility Center; 🇺🇸 Orange, Connecticut, United States