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

NCT ID: NCT02668965

Last Updated: 2016-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-04-30

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.

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.

Conditions

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Infertility

Keywords

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Clinical pregnancy rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

intrauterine hCG

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

Group Type EXPERIMENTAL

Intrauterine hCG (pregnyl)

Intervention Type PROCEDURE

Interventions

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Intrauterine hCG (pregnyl)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Savinee Boonsuk

Miss

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Infertility unit, Siriraj Hospital

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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savinee boonsuk, M.D.

Role: CONTACT

Phone: +66818706643

Email: [email protected]

Facility Contacts

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savinee boonsuk, M.D.

Role: primary

Pitak Laokrikkiat, M.D.

Role: backup

Other Identifiers

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Si701/2015

Identifier Type: -

Identifier Source: org_study_id