NCT01986374CompletedNot Applicable
Intrauterine Injection of Human Chorionic Gonadotropin to Enhance Embryo Implantation
Servy Massey Fertility Insititute1 site in 1 country75 target enrollmentStarted: June 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- HCG enhances pregnancy rate
Study Overview
Brief Summary
The endometrium is deprived of signals form the embryo in IVF conditions. Studies suggest that placing HCG into the uterus prior to embryo transfer can enhance implantation.
Detailed Description
The study is in pilot phase, uncontrolled. The risks appear to be minimal and there are conflicting new reports being announced.
A small amount of fluid with HCG is injected into the uterus. HCG is a potent signal to the uterus for preparation for implantation.
This is not a funded study. Three published studies suggest the approach is valid; one refutes the concept.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 47 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •infertility patients undergoing IVF with good expectation of two embryos day 3 or day
- •must speak and read English. Includes donor eggs.
Exclusion Criteria
- •abnormal uterus
Arms & Interventions
HCG is introduced with small catheter.
Experimental
phase 1 non randomized pilot
Intervention: HCG is introduced (Drug)
Outcomes
Primary Outcomes
HCG enhances pregnancy rate
Time Frame: 9 months.
compare pregnancy rates to established clinical norms.
Secondary Outcomes
- ongoing pregnancy rate(22 months)
- implantation rate(18 months)
Investigators
Study Sites (1)
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