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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Intrauterine hCG (pregnyl)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical pregnancy rate