Clincosm LogoSign in Get a demo

Injection of Hormone to Enhance Implantation in Embryo Transfer After IVF

Sponsor
Servy Massey Fertility Insititute (Other)
Overall Status
Completed
CT.gov ID
NCT01986374
Collaborator
(none)
75
Enrollment
1
Location
1
Arm
32
Duration (Months)
2.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: HCG is introduced
 N/A

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
Actual Enrollment :
75 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Intrauterine Injection of Human Chorionic Gonadotropin to Enhance Embryo Implantation
Study Start Date :
Jun 1, 2013
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: HCG is introduced with small catheter.

phase 1 non randomized pilot

Drug: HCG is introduced
must have good blastocysts
Other Names:
  • Improve results of IVF and embryo transfer

    		•

    Outcome Measures

    Primary Outcome Measures

    1. HCG enhances pregnancy rate [9 months.]

      compare pregnancy rates to established clinical norms.

    Secondary Outcome Measures

    1. implantation rate [18 months]

      compare implantation rate per embryo to clinical norms.

    2. ongoing pregnancy rate [22 months]

      compare success to clinical norms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 47 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Servy Massey Fertility Insititute Atlanta Georgia United States 30327

    Sponsors and Collaborators

    • Servy Massey Fertility Insititute

    Investigators

    • Study Chair: Joe B Massey, MD, Servy Massey Fertilty Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Servy Massey Fertility Insititute
    ClinicalTrials.gov Identifier:
    NCT01986374
    Other Study ID Numbers:
    • HCG 2013
    First Posted:
    Nov 18, 2013
    Last Update Posted:
    Mar 19, 2020
    Last Verified:
    Nov 1, 2013
    Keywords provided by Servy Massey Fertility Insititute
    IVF , embryo implantation, HCG
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Mar 19, 2020