Injection of Hormone to Enhance Implantation in Embryo Tr... | NCT01986374

Studies
Injection of Hormone to Enhance Implantation in Embryo Transfer After IVF

NCT01986374

Sponsor

Servy Massey Fertility Insititute

Status

Completed

Last Update Posted

Mar 19, 2020Actual

Enrollment

75Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

HCG is introduced

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Dec 2015Actual

Completion Date

Feb 2016Actual

First Submitted Date

Nov 11, 2013

First Submission Date that Met QC Criteria

Nov 15, 2013

First Posted Date

Nov 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2020

Last Update Posted Date

Mar 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HCG is introduced with small catheter.	Experimental	phase 1 non randomized pilot	Drug: HCG is introduced

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HCG is introduced	Drug	must have good blastocysts	HCG is introduced with small catheter.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HCG enhances pregnancy rate	compare pregnancy rates to established clinical norms.	9 months.

Secondary Outcomes

Measure	Description	Time Frame
implantation rate	compare implantation rate per embryo to clinical norms.	18 months
ongoing pregnancy rate	compare success to clinical norms

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

47 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joe B Massey, MD	Servy Massey Fertilty Institute	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Servy Massey Fertility Insititute		Atlanta	Georgia	30327	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22047664	Background	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.
24799855

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
D027724	Reproductive Techniques, Assisted
D012099	Reproductive Techniques
D013812	Therapeutics
D008919	Investigative Techniques