The Effects of Intrauterine Infusion of hCG at the Time of Embryo Transfer

January 28, 2016 updated by: Savinee Boonsuk, Mahidol University

The Effects of Intrauterine Infusion of Human Chorionic Gonadotropin at the Time of Embryo Transfer on IVF/ICSI Outcomes: Randomized, Double-blind Controlled Study

The purpose of this study is to determine whether intrauterine hCG can improve the implantation rate and clinical pregnancy rate after embryo transfer in IVF/ICSI cycle.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients at infertility clinic, siriraj hospital who come to start IVF/ICSI treatment cycle or endometrial preparation for embryo transfer are consiferes as eligible subjects.

On the day of embryo transfer (both fresh and frozen-thaw cycle), the subjects will be randomized to 2 groups.

  1. control group: embryo transfer after intrauterine infusion with standard embryo culture media 4-7 minutes
  2. study group: embryo transfer after intrauterine infusion with hCG (Pregnyl) 4-7 minutes

The patients will come back for serum beta-hCG measurement 2 weeks later after embryo transfer and other 2 weeks later for transvaginal ultrasound if beta-hCG is positive.

Study Type

Interventional

Enrollment (Anticipated)

200

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 Contact

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Infertility unit, Siriraj Hospital
        • Contact:
        • Contact:

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

16 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. infertile women aged 18-43 years
  2. indicated or willing for IVF/ICSI treatment or endometrial preparation for embryo transfer

Exclusion Criteria:

  1. Azoospermic male partner
  2. Failure to retrieve oocyte after controlled ovarian hyperstimulation
  3. No embryo retrieved for transfer
  4. Endometrial preparation failure

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
intrauterine infusion with standard embryo culture media 10 microliters before embryo transfer
Experimental: intrauterine hCG
intrauterine infusion with hCG (500 IU) 10 microliters before embryo transfer
Procedure: Intrauterine hCG (pregnyl)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 2 weeks after positive serum beta-hCG
Transvaginal ultrasound to confirm number of intrauterine gestational sac and fetal heart beats
2 weeks after positive serum beta-hCG

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemical pregnancy rate
Time Frame: 2 weeks after embryo transfer
positive serum beta-hCG more than 3
2 weeks after embryo transfer
Implantation rate
Time Frame: 2 weeks after positive serum beta-hCG
number of intrauterine gestational sac / number of embryo transferred
2 weeks after positive serum beta-hCG

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

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

December 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Estimate)

January 29, 2016

Last Update Submitted That Met QC Criteria

January 28, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si701/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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.

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