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Sponsor study identifier
interventional
300
1 country
2
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2014
Actual (reported)Study Completion
November 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
June 28, 2012
Actual (reported)July 18, 2012
Actual (reported)January 2014
Actual (reported)November 2014
Actual (reported)Sustained implantation rate
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).
12 weeks
Ongoing pregnancy rate
9 Weeks
Patients will have hCG and media (for a total of 20 microliters) inserted during a mock embryo transfer immediately prior to actual embryo transfer.
Patients will have 20 microliters of media inserted during a mock embryo transfer immediately prior to actual embryo transfer.
hCG will be included in the 20 microliters of media inserted during a mock embryo transfer immediately prior to actual embryo transfer.
Patients will have 20 microliters of media inserted during a mock embryo transfer immediately prior to actual embryo transfer.
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07960, United States
Reproductive Medicine Associates of Pennsylvania at Lehigh Valley
Allentown, Pennsylvania, 18104, United States
Hong KH, Forman EJ, Werner MD, Upham KM, Gumeny CL, Winslow AD, Kim TJ, Scott RT Jr. Endometrial infusion of human chorionic gonadotropin at the time of blastocyst embryo transfer does not impact clinical outcomes: a randomized, double-blind, placebo-controlled trial. Fertil Steril. 2014 Dec;102(6):1591-5.e2. doi: 10.1016/j.fertnstert.2014.08.006. Epub 2014 Sep 16.
Richard T Scott, MD
Reproductive Medicine Associates of New Jersey
300 participants (actual enrollment reported by the registry).
First Submitted
June 28, 2012
First Posted
July 18, 2012
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
January 2014
Actual (reported)Study Completion
November 2014
Actual (reported)Last Updated
January 26, 2015
Record last verified: 2015-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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