Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium

Launched by HUGH TAYLOR · Apr 18, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for women with specific conditions related to the uterus, such as Asherman Syndrome (AS), Atrophic Endometrium (AE), and Recurrent Implantation Failure (RIF). The treatment involves using a special method to gather stem cells from the patient's own bone marrow, with the hope that these cells can help improve the health of the uterine lining and support pregnancy efforts. The study is currently recruiting healthy women aged 18 to 40 who meet certain criteria, including having a history of uterine trauma or complications, a thin uterine lining, or difficulties becoming pregnant despite multiple embryo transfers.

Participants in the trial will undergo a procedure to mobilize their bone marrow stem cells, which will then be used to see if they can positively impact their uterine conditions. It's important to note that women who are currently pregnant, have certain medical issues, or cannot provide informed consent will not be eligible for this study. If you think you might qualify and are interested in learning more, this trial could offer a new avenue to explore for enhancing fertility and uterine health.

Gender

FEMALE

Eligibility criteria

• 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
• 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