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Trial record 70 of 415 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

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

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ClinicalTrials.gov Identifier: NCT02668965
Recruitment Status : Unknown
Verified January 2016 by Savinee Boonsuk, Mahidol University.
Recruitment status was:  Recruiting
First Posted : January 29, 2016
Last Update Posted : January 29, 2016
Sponsor:
Information provided by (Responsible Party):
Savinee Boonsuk, 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.

Condition or disease Intervention/treatment Phase
Infertility Procedure: Intrauterine hCG (pregnyl) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Health Services Research
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 Start Date : December 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
No Intervention: control
intrauterine infusion with standard embryo culture media 10 microliters before embryo transfer
Experimental: intrauterine hCG
intrauterine infusion with hCG (500 IU) 10 microliters before embryo transfer
Procedure: Intrauterine hCG (pregnyl)



Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 2 weeks after positive serum beta-hCG ]
    Transvaginal ultrasound to confirm number of intrauterine gestational sac and fetal heart beats


Secondary Outcome Measures :
  1. Chemical pregnancy rate [ Time Frame: 2 weeks after embryo transfer ]
    positive serum beta-hCG more than 3

  2. Implantation rate [ Time Frame: 2 weeks after positive serum beta-hCG ]
    number of intrauterine gestational sac / number of embryo transferred



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668965


Contacts
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Contact: savinee boonsuk, M.D. +66818706643 noomnim_mu@hotmail.com

Locations
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Thailand
Infertility unit, Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: savinee boonsuk, M.D.    +66818706643    noomnim_mu@hotmail.com   
Contact: Pitak Laokrikkiat, M.D.    +66890009977    siplo@mahidol.ac.th   
Sponsors and Collaborators
Mahidol University

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Responsible Party: Savinee Boonsuk, Miss, Mahidol University
ClinicalTrials.gov Identifier: NCT02668965     History of Changes
Other Study ID Numbers: Si701/2015
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Savinee Boonsuk, Mahidol University:
Clinical pregnancy rate
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs