Intrauterine Human Chorionic Gonadotropin at the Time of Embryo Transfer
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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 |
- 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).
- 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 |
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| Contact: Monica R Benson, RN | 973-656-2841 | clinicalresearchteam@rmanj.com |
| Contact: Janine M Casciello, BA | 973-656-2841 | clinicalresearchteam@rmanj.com |
| United States, New Jersey | |
| Reproductive Medicine Associates of New Jersey | Recruiting |
| Basking Ridge, New Jersey, United States, 07960 | |
| Contact: Monica R Benson, RN 973-656-2841 clinicalresearchteam@rmanj.com | |
| Contact: Janine Casciello, BA 973-656-2841 clinicalresearchteam@rmanj.com | |
| Principal Investigator: Richard T Scott, MD | |
| Sub-Investigator: Paul A Bergh, MD | |
| Sub-Investigator: Michael K Borher, MD | |
| Sub-Investigator: Maria Constantini-Ferrando, MD, PhD | |
| Sub-Investigator: Michael R Drews, MD | |
| Sub-Investigator: Kathleen M Ferry, BS | |
| Sub-Investigator: Rita Gulati, MD | |
| Sub-Investigator: Doreen Hock, MD | |
| Sub-Investigator: Thomas Kim, MD | |
| Sub-Investigator: Marcy F Maguire, MD | |
| Sub-Investigator: Thomas A Molinaro, MD | |
| Sub-Investigator: Jamie Morris, MD | |
| Sub-Investigator: Eli Rybak, MD | |
| Sub-Investigator: Shefali Shastri, MD | |
| United States, Pennsylvania | |
| Reproductive Medicine Associates of Pennsylvania at Lehigh Valley | Recruiting |
| Allentown, Pennsylvania, United States, 18104 | |
| Contact: Monica R Benson, RN 973-656-2841 clinicalresearchteam@rmanj.com | |
| Contact: Janine Casciello, BA 973-656-2841 clinicalresearchteam@rmanj.com | |
| Principal Investigator: Richard T Scott, MD | |
| Sub-Investigator: Wendy Shillings, MD | |
| 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: | March 4, 2013 |
| 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 May 23, 2013