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

Not Applicable

• Conditions: Infertility
• Interventions: Procedure: Intrauterine hCG (pregnyl)

• Registration Number: NCT02668965
• Lead Sponsor: Mahidol University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-12
• Status Verified: 2016-01
• Study First Submitted: 2016-01-27
• Study First Submitted QC: 2016-01-28
• Last Update Submitted: 2016-01-28
• Study First Posted: 2016-01-29
• Last Update Posted: 2016-01-29
• Primary Completion: 2016-03
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intrauterine hCG	Intrauterine hCG (pregnyl)	intrauterine infusion with hCG (500 IU) 10 microliters before embryo transfer

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	2 weeks after positive serum beta-hCG	Transvaginal ultrasound to confirm number of intrauterine gestational sac and fetal heart beats

Secondary Outcome Measures

Name	Time	Method
Chemical pregnancy rate	2 weeks after embryo transfer	positive serum beta-hCG more than 3
Implantation rate	2 weeks after positive serum beta-hCG	number of intrauterine gestational sac / number of embryo transferred

Trial Locations

Locations (1)

Infertility unit, Siriraj Hospital; 🇹🇭 Bangkok, Thailand