Injection of Hormone to Enhance Implantation in Embryo Transfer After IVF
March 17, 2020 updated by: Servy Massey Fertility Insititute
Intrauterine Injection of Human Chorionic Gonadotropin to Enhance Embryo Implantation
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
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Atlanta, Georgia, United States, 30327
- Servy Massey Fertility Insititute
-
-
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.
Eligibility Criteria
Ages Eligible for Study
21 years to 47 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- infertility patients undergoing IVF with good expectation of two embryos day 3 or day 5. must speak and read English. Includes donor eggs.
Exclusion Criteria:abnormal uterus
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HCG is introduced with small catheter.
phase 1 non randomized pilot
|
must have good blastocysts
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HCG enhances pregnancy rate
Time Frame: 9 months.
|
compare pregnancy rates to established clinical norms.
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9 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
implantation rate
Time Frame: 18 months
|
compare implantation rate per embryo to clinical norms.
|
18 months
|
|
ongoing pregnancy rate
Time Frame: 22 months
|
compare success to clinical norms
|
22 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Joe B Massey, MD, Servy Massey Fertilty Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mansour R, Tawab N, Kamal O, El-Faissal Y, Serour A, Aboulghar M, Serour G. Intrauterine injection of human chorionic gonadotropin before embryo transfer significantly improves the implantation and pregnancy rates in in vitro fertilization/intracytoplasmic sperm injection: a prospective randomized study. Fertil Steril. 2011 Dec;96(6):1370-1374.e1. doi: 10.1016/j.fertnstert.2011.09.044. Epub 2011 Nov 1.
- Zarei A, Parsanezhad ME, Younesi M, Alborzi S, Zolghadri J, Samsami A, Amooee S, Aramesh S. Intrauterine administration of recombinant human chorionic gonadotropin before embryo transfer on outcome of in vitro fertilization/ intracytoplasmic sperm injection: A randomized clinical trial. Iran J Reprod Med. 2014 Jan;12(1):1-6.
- Santibanez A, Garcia J, Pashkova O, Colin O, Castellanos G, Sanchez AP, De la Jara JF. Effect of intrauterine injection of human chorionic gonadotropin before embryo transfer on clinical pregnancy rates from in vitro fertilisation cycles: a prospective study. Reprod Biol Endocrinol. 2014 Jan 29;12:9. doi: 10.1186/1477-7827-12-9.
- Hong KH, Forman EJ, Werner MD, Upham KM, Gumeny CL, Winslow AD, Kim TJ, Scott RT Jr. Endometrial infusion of human chorionic gonadotropin at the time of blastocyst embryo transfer does not impact clinical outcomes: a randomized, double-blind, placebo-controlled trial. Fertil Steril. 2014 Dec;102(6):1591-5.e2. doi: 10.1016/j.fertnstert.2014.08.006. Epub 2014 Sep 16.
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 Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
November 11, 2013
First Submitted That Met QC Criteria
November 15, 2013
First Posted (Estimate)
November 18, 2013
Study Record Updates
Last Update Posted (Actual)
March 19, 2020
Last Update Submitted That Met QC Criteria
March 17, 2020
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCG 2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.