RECRUITING

Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium

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Conditions

Asherman SyndromeAtrophic EndometriumRecurrent Implantation Failurebone marrow derived stem cells

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2023-11-01
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05343572

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy, non pregnant females
  2. * ages ≥18 and ≤40 years old at time of enrollment
  3. * with either AS, AE, or RIF
  4. 1. For AS: surgical history of intrauterine trauma/infection, hypo/amenorrhea, intra-uterine adhesions
  5. 2. for AE: US documentation of persistent, \<6mm endometrial thickness
  6. 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
  1. * Presence of hydrosalpinx (diagnosed by radiographic or ultrasound imaging)
  2. * Endometriosis (diagnosed by previous surgery,)
  3. * Diminished ovarian reserve (AMH\<1ng/ml or follicle stimulating hormone (FSH)\>10)
  4. * History of genital tuberculosis or any ultrasound evidence of congenital uterine anomaly
  5. * Submucous or intracavitary fibroid, polyps
  6. * Currently pregnant
  7. * Personal history of thrombophilia or sickle cell disease
  8. * Inability to provide informed consent

Contacts and Locations

Study Contact

Hugh S Taylor, MD
CONTACT
(203)-785-6949
hugh.taylor@yale.edu
Michele Frank, BSN
CONTACT
(203)-785-2164
Michele.Frank@yale.edu

Principal Investigator

Hugh Taylor, MD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale Fertility Center
Orange, Connecticut, 06477
United States

Collaborators and Investigators

Sponsor: Hugh Taylor

  • Hugh Taylor, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-01
Study Completion Date2026-12

Study Record Updates

Study Start Date2023-11-01
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • bone marrow derived stem cells

Additional Relevant MeSH Terms

  • Asherman Syndrome
  • Atrophic Endometrium
  • Recurrent Implantation Failure