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Intrauterine Human Chorionic Gonadotropin at the Time of Embryo Transfer

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ClinicalTrials.gov Identifier: NCT01643993
Recruitment Status : Completed
First Posted : July 18, 2012
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey

Brief Summary:

Techniques to improve pregnancy and delivery rates in IVF cycles have focused not only on the embryos transferred, but also the conditions in the uterus at the time of transfer and implantation. Prior studies have shown that embryos secrete human chorionic gonadotropin (hCG) prior to implantation. However, in IVF cycles, the embryos have limited time to secrete hCG before implantation must occur because embryos are placed into the uterus rather than traveling there from the fallopian tubes. Recent studies have shown that the introduction of hCG into the uterus prior to embryo transfer may make the uterus more receptive to implantation. These studies involved day 3 embryos and the investigators are seeking to evaluate the potential benefits of hCG on implantation rates of blastocysts (day 5 or day 6 embryos).

The purpose of this study is to determine whether infusion of human chorionic gonadotropin (hCG) into the uterus immediately prior to embryo transfer results in increased implantation rates.

The entire IVF cycle, fresh or frozen, will be conducted per routine. All laboratory culture conditions will be per routine. In fresh and frozen IVF cycles, an embryo transfer will be performed per routine.

At the time of embryo transfer, participants will be randomly assigned to either the control group or the hCG group. Patients in the hCG group will have a mock embryo transfer with 20µL of transfer media including 500IU of hCG. Patients in the control group will have a mock embryo transfer with 20µL of transfer media.

All post-transfer care and pregnancy monitoring will be identical and per routine protocol.


Condition or disease Intervention/treatment Phase
Control Media Only Study hCG and Media Other: hCG at the Time of Embryo Transfer Other: Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intrauterine Human Chorionic Gonadotropin at the Time of Embryo Transfer: A Randomized Controlled Trial
Study Start Date : May 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: hCG at Time of Embryo Transfer
Patients will have hCG and media (for a total of 20 microliters) inserted during a mock embryo transfer immediately prior to actual embryo transfer.
Other: hCG at the Time of Embryo Transfer
hCG will be included in the 20 microliters of media inserted during a mock embryo transfer immediately prior to actual embryo transfer.
Control
Patients will have 20 microliters of media inserted during a mock embryo transfer immediately prior to actual embryo transfer.
Other: Control
Patients will have 20 microliters of media inserted during a mock embryo transfer immediately prior to actual embryo transfer.



Primary Outcome Measures :
  1. Sustained implantation rate [ Time Frame: 12 weeks ]
    Sustained implantation rate is measured as the number of fetal heart beats seen at the time of patient discharge to OB/GYN care (approximately 8 weeks gestation).


Secondary Outcome Measures :
  1. Ongoing pregnancy rate [ Time Frame: 9 Weeks ]
    The number of pregnancies with at least one fetal heart beat seen at the time of discharge to OB/GYN care per embryo transfer.



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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:

  • all patients 43 years old or under undergoing fresh or frozen IVF cycles are eligible to participate

Exclusion Criteria:

  • patients greater than 43 years old
  • patinets currently participating in any other research studies

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): NCT01643993


Locations
United States, New Jersey
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, United States, 07960
United States, Pennsylvania
Reproductive Medicine Associates of Pennsylvania at Lehigh Valley
Allentown, Pennsylvania, United States, 18104
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Investigators
Principal Investigator: Richard T Scott, MD Reproductive Medicine Associates of New Jersey

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT01643993     History of Changes
Other Study ID Numbers: RMA-2012-01
First Posted: July 18, 2012    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015

Keywords provided by Reproductive Medicine Associates of New Jersey:
IVF
embryo

Additional relevant MeSH terms:
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs