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

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Intrauterine hCG (pregnyl)
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Infertility focused on measuring Clinical pregnancy rate

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Infertility unit, Siriraj HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control

intrauterine hCG

Arm Description

intrauterine infusion with standard embryo culture media 10 microliters before embryo transfer

intrauterine infusion with hCG (500 IU) 10 microliters before embryo transfer

Outcomes

Primary Outcome Measures

Clinical pregnancy rate
Transvaginal ultrasound to confirm number of intrauterine gestational sac and fetal heart beats

Secondary Outcome Measures

Chemical pregnancy rate
positive serum beta-hCG more than 3
Implantation rate
number of intrauterine gestational sac / number of embryo transferred

Full Information

First Posted
January 27, 2016
Last Updated
January 28, 2016
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02668965
Brief Title
The Effects of Intrauterine Infusion of hCG at the Time of Embryo Transfer
Official Title
The Effects of Intrauterine Infusion of Human Chorionic Gonadotropin at the Time of Embryo Transfer on IVF/ICSI Outcomes: Randomized, Double-blind Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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. control group: embryo transfer after intrauterine infusion with standard embryo culture media 4-7 minutes 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Clinical pregnancy rate

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
intrauterine infusion with standard embryo culture media 10 microliters before embryo transfer
Arm Title
intrauterine hCG
Arm Type
Experimental
Arm Description
intrauterine infusion with hCG (500 IU) 10 microliters before embryo transfer
Intervention Type
Procedure
Intervention Name(s)
Intrauterine hCG (pregnyl)
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Transvaginal ultrasound to confirm number of intrauterine gestational sac and fetal heart beats
Time Frame
2 weeks after positive serum beta-hCG
Secondary Outcome Measure Information:
Title
Chemical pregnancy rate
Description
positive serum beta-hCG more than 3
Time Frame
2 weeks after embryo transfer
Title
Implantation rate
Description
number of intrauterine gestational sac / number of embryo transferred
Time Frame
2 weeks after positive serum beta-hCG

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: infertile women aged 18-43 years indicated or willing for IVF/ICSI treatment or endometrial preparation for embryo transfer Exclusion Criteria: Azoospermic male partner Failure to retrieve oocyte after controlled ovarian hyperstimulation No embryo retrieved for transfer Endometrial preparation failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
savinee boonsuk, M.D.
Phone
+66818706643
Email
noomnim_mu@hotmail.com
Facility Information:
Facility Name
Infertility unit, Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
savinee boonsuk, M.D.
Phone
+66818706643
Email
noomnim_mu@hotmail.com
First Name & Middle Initial & Last Name & Degree
Pitak Laokrikkiat, M.D.
Phone
+66890009977
Email
siplo@mahidol.ac.th

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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