Control Media OnlyNCT01643993
Intrauterine Human Chorionic Gonadotropin at the Time of Embryo Transfer
A study testing hCG at the Time of Embryo Transfer in people with Control Media Only and Study hCG and Media, run by Reproductive Medicine Associates of New Jersey at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Control Media Only, Study hCG and Media
- What is being tested?
- hCG at the Time of Embryo Transfer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- all patients 43 years old or under undergoing fresh or frozen IVF cycles are eligible to participate
Who cannot join
- patients greater than 43 years old
- patinets currently participating in any other research studies
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Reproductive Medicine Associates of Pennsylvania at Lehigh Valley
Allentown, Pennsylvania, 18104
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07960
About this study
Official title: 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.
Read more
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
- Being tested
- hCG at the Time of Embryo Transfer, Control
- Keywords
- IVF, embryo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hCG at the Time of Embryo TransferOther
hCG will be included in the 20 microliters of media inserted during a mock embryo transfer immediately prior to actual embryo transfer.
ControlOther
Patients will have 20 microliters of media inserted during a mock embryo transfer immediately prior to actual embryo transfer.
| Study group | Role | What they receive |
|---|---|---|
| hCG at Time of Embryo Transfer | Experimental | Patients will have hCG and media (for a total of 20 microliters) inserted during a mock embryo transfer immediately prior to actual embryo transfer. Receives: Other: hCG at the Time of Embryo Transfer |
| Control | Other | Patients will have 20 microliters of media inserted during a mock embryo transfer immediately prior to actual embryo transfer. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 9 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Control Media OnlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard T Scott, MD, Principal investigator, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643993
- Sponsor's protocol ID
- RMA-2012-01
- Status last verified
- Jan 2015
- First submitted
- 28 Jun 2012
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25234040
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Human Chorionic Gonadotropin at the Time of Embryo Transfer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01643993
- Acronym / sponsor ID
- RMA-2012-01
- Conditions
- Control Media Only, Study hCG and Media
- Keywords
- IVF, embryo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hCG at Time of Embryo Transfer | Experimental | Other: hCG at the Time of Embryo TransferPatients will have hCG and media (for a total of 20 microliters) inserted during a mock embryo transfer immediately prior to actual embryo transfer. |
| Control | Other | Other: ControlPatients will have 20 microliters of media inserted during a mock embryo transfer immediately prior to actual embryo transfer. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all patients 43 years old or under undergoing fresh or frozen IVF cycles are eligible to participate
Key exclusion criteria (2 listed)
- patients greater than 43 years old
- patinets currently participating in any other research studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hCG at the Time of Embryo TransferhCG will be included in the 20 microliters of media inserted during a mock embryo transfer immediately prior to actual embryo transfer. | Other | hCG at Time of Embryo Transfer |
| ControlPatients will have 20 microliters of media inserted during a mock embryo transfer immediately prior to actual embryo transfer. | Other | Control |
Primary outcome
Sustained implantation rate
Time frame: 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).
1 secondary outcome
Ongoing pregnancy rate
Time frame: 9 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Derived from this study: PubMed 25234040Hong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard T Scott, MD principal investigator
Reproductive Medicine Associates of New Jersey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hCG at the Time of Embryo Transfer in people with Control Media Only and Study hCG and Media, run by Reproductive Medicine Associates of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained implantation rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01643993, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2015.