Intrauterine Human Chorionic Gonadotropin at the Time of Embryo Transfer

NCT ID: NCT01643993

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-11-30

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.

Conditions

Control Media Only; Study hCG and Media

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

hCG at the Time of Embryo Transfer

Intervention Type: OTHER

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.

Group Type: OTHER

Control

Intervention Type: OTHER

Patients will have 20 microliters of media inserted during a mock embryo transfer immediately prior to actual embryo transfer.

Interventions

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.

Intervention Type: OTHER

Control

Patients will have 20 microliters of media inserted during a mock embryo transfer immediately prior to actual embryo transfer.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Reproductive Medicine Associates of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard T Scott, MD

Role: PRINCIPAL_INVESTIGATOR

Reproductive Medicine Associates of New Jersey

Locations

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, United States

Reproductive Medicine Associates of Pennsylvania at Lehigh Valley

Allentown, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25234040 (View on PubMed)

Other Identifiers

RMA-2012-01

Identifier Type: -

Identifier Source: org_study_id