NCT01986374

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 19, 2020

Status Verified

November 1, 2013

Enrollment Period

2.5 years

First QC Date

November 11, 2013

Last Update Submit

March 17, 2020

Conditions

Infertility

Keywords

IVF , embryo implantation, HCG

Outcome Measures

Primary Outcomes (1)

  • HCG enhances pregnancy rate

    compare pregnancy rates to established clinical norms.

    9 months.

Secondary Outcomes (2)

  • implantation rate

    18 months

  • ongoing pregnancy rate

    22 months

Study Arms (1)

HCG is introduced with small catheter.

EXPERIMENTAL

phase 1 non randomized pilot

Drug: HCG is introduced

Interventions

HCG is introducedDRUG

must have good blastocysts

Also known as: Improve results of IVF and embryo transfer
HCG is introduced with small catheter.

Eligibility Criteria

Age21 Years - 47 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- infertility patients undergoing IVF with good expectation of two embryos day 3 or day 5. must speak and read English. Includes donor eggs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servy Massey Fertility Insititute

Atlanta, Georgia, 30327, United States

Location

Related Publications (4)

  • 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.

    PMID: 22047664BACKGROUND

  • 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.

    PMID: 24799855BACKGROUND

  • 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.

    PMID: 24476536BACKGROUND

  • 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.

    PMID: 25234040BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Embryo Transfer

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Joe B Massey, MD

    Servy Massey Fertilty Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2013

First Posted

November 18, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

March 19, 2020

Record last verified: 2013-11

Locations

US(1)