Intrauterine Human Chorionic Gonadotropin at the Time of Embryo Transfer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier:
NCT01643993
First received: June 28, 2012
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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 Intervention
Control Media Only
Study hCG and Media
Other: hCG at the Time of Embryo Transfer
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intrauterine Human Chorionic Gonadotropin at the Time of Embryo Transfer: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Reproductive Medicine Associates of New Jersey:

Primary Outcome Measures:
  • Sustained implantation rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Ongoing pregnancy rate [ Time Frame: 9 Weeks ] [ Designated as safety issue: No ]
    The number of pregnancies with at least one fetal heart beat seen at the time of discharge to OB/GYN care per embryo transfer.


Estimated Enrollment: 800
Study Start Date: May 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 43 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT01643993     History of Changes
Other Study ID Numbers: RMA-2012-01
Study First Received: June 28, 2012
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014