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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02668965
• Other study ID #: Si701/2015
• Status: Recruiting
• Phase: N/A
• First received: January 27, 2016
• Last updated: January 28, 2016
• Start date: December 2015
• Est. completion date: April 2016

Study information

• Verified date: January 2016
• Source: Mahidol University
• Contact: savinee boonsuk, M.D.
• Phone: +66818706643
• Email: noomnim_mu[@]hotmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Intrauterine hCG (pregnyl)

Locations

Country	Name	City	State
Thailand	Infertility unit, Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Transvaginal ultrasound to confirm number of intrauterine gestational sac and fetal heart beats	2 weeks after positive serum beta-hCG	No
Secondary	Chemical pregnancy rate	positive serum beta-hCG more than 3	2 weeks after embryo transfer	No
Secondary	Implantation rate	number of intrauterine gestational sac / number of embryo transferred	2 weeks after positive serum beta-hCG	No