Back to resultsInjection of Hormone to Enhance Implantation in Embryo Transfer After IVF
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HCG is introduced
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring IVF , embryo implantation, HCG
Eligibility Criteria
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
-
Sites / Locations
- Servy Massey Fertility Insititute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HCG is introduced with small catheter.
Arm Description
phase 1 non randomized pilot
Outcomes
Primary Outcome Measures
HCG enhances pregnancy rate
compare pregnancy rates to established clinical norms.
Secondary Outcome Measures
implantation rate
compare implantation rate per embryo to clinical norms.
ongoing pregnancy rate
compare success to clinical norms
Full Information
NCT ID
NCT01986374
First Posted
November 11, 2013
Last Updated
March 17, 2020
Sponsor
Servy Massey Fertility Insititute
1. Study Identification
Unique Protocol Identification Number
NCT01986374
Brief Title
Injection of Hormone to Enhance Implantation in Embryo Transfer After IVF
Official Title
Intrauterine Injection of Human Chorionic Gonadotropin to Enhance Embryo Implantation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Servy Massey Fertility Insititute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF , embryo implantation, HCG
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HCG is introduced with small catheter.
Arm Type
Experimental
Arm Description
phase 1 non randomized pilot
Intervention Type
Drug
Intervention Name(s)
HCG is introduced
Other Intervention Name(s)
Improve results of IVF and embryo transfer
Intervention Description
must have good blastocysts
Primary Outcome Measure Information:
Title
HCG enhances pregnancy rate
Description
compare pregnancy rates to established clinical norms.
Time Frame
9 months.
Secondary Outcome Measure Information:
Title
implantation rate
Description
compare implantation rate per embryo to clinical norms.
Time Frame
18 months
Title
ongoing pregnancy rate
Description
compare success to clinical norms
Time Frame
22 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
47 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joe B Massey, MD
Organizational Affiliation
Servy Massey Fertilty Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Servy Massey Fertility Insititute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22047664
Citation
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.
Results Reference
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PubMed Identifier
24799855
Citation
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.
Results Reference
background
PubMed Identifier
24476536
Citation
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.
Results Reference
background
PubMed Identifier
25234040
Citation
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.
Results Reference
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Injection of Hormone to Enhance Implantation in Embryo Transfer After IVF
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