Intrauterine Human Chorionic Gonadotropin at the Time of Embryo Transfer

Not Applicable

Completed

• Conditions: Study hCG and Media; Control Media Only
• Interventions: Other: Control; Other: hCG at the Time of Embryo Transfer

• Registration Number: NCT01643993
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-28
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-18
• Primary Completion: 2014-01
• Study Completion: 2014-11
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-21
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Patients will have 20 microliters of media inserted during a mock embryo transfer immediately prior to actual embryo transfer.
hCG at Time of Embryo Transfer	hCG at the 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.

Primary Outcome Measures

Name	Time	Method
Sustained implantation rate	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

Name	Time	Method
Ongoing pregnancy rate	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.

Trial Locations

Locations (2)

Reproductive Medicine Associates of New Jersey; 🇺🇸 Basking Ridge, New Jersey, United States

Reproductive Medicine Associates of Pennsylvania at Lehigh Valley; 🇺🇸 Allentown, Pennsylvania, United States