Intrauterine Human Chorionic Gonadotropin at the Time of Embryo Transfer

Intrauterine Human Chorionic Gonadotropin at the Time of Embryo Transfer: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Control Media Only; Study hCG and Media
• Intervention / Treatment: Other: hCG at the Time of Embryo Transfer; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07960
      • Reproductive Medicine Associates of New Jersey
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Reproductive Medicine Associates of Pennsylvania at LeHigh Valley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Reproductive Medicine Associates of New Jersey
• Investigators: Principal Investigator: Richard T Scott, MD, Reproductive Medicine Associates of New Jersey

Publications and helpful links

General Publications

• 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.

Helpful Links

• Reproductive Medicine Associates of New Jersey

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: June 28, 2012
• First Submitted That Met QC Criteria: July 17, 2012
• First Posted (Estimate): July 18, 2012

Study Record Updates

• Last Update Posted (Estimate): January 26, 2015
• Last Update Submitted That Met QC Criteria: January 21, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: IVF; embryo
• Other Study ID Numbers: RMA-2012-01