No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 40
Sex
Female
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
Hugh Taylor · Other
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
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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 endometria…
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
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