InfertilityNCT01986374
Injection of Hormone to Enhance Implantation in Embryo Transfer After IVF
A study testing HCG is introduced in people with Infertility, run by Servy Massey Fertility Insititute at 1 site in United States.
Trial summary
The endometrium is deprived of signals form the embryo in IVF conditions. Studies suggest that placing HCG into the uterus prior to embryo transfer can enhance implantation. Read more about this study
- Who is it for?
- Ages 21 to 47 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- HCG is introduced
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Feb 2016
- 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 21 to 47 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- infertility patients undergoing IVF with good expectation of two embryos day 3 or day 5. must speak and read English. Includes donor eggs.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Servy Massey Fertility Insititute
Atlanta, Georgia, 30327
About this study
Official title: Intrauterine Injection of Human Chorionic Gonadotropin to Enhance Embryo Implantation
The endometrium is deprived of signals form the embryo in IVF conditions. Studies suggest that placing HCG into the uterus prior to embryo transfer can enhance implantation.
Read the detailed description
The study is in pilot phase, uncontrolled. The risks appear to be minimal and there are conflicting new reports being announced.
A small amount of fluid with HCG is injected into the uterus. HCG is a potent signal to the uterus for preparation for implantation.
This is not a funded study. Three published studies suggest the approach is valid; one refutes the concept.
- Conditions
- Infertility
- Being tested
- HCG is introduced
- Keywords
- IVF , embryo implantation, HCG
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCG is introducedDrug
Also called Improve results of IVF and embryo transfer
must have good blastocysts
| Study group | Role | What they receive |
|---|---|---|
| HCG is introduced with small catheter. | Experimental | phase 1 non randomized pilot Receives: Drug: HCG is introduced |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCG enhances pregnancy rate
compare pregnancy rates to established clinical norms.
Measured: 9 months.
Secondary outcomes (2)
implantation rate
compare implantation rate per embryo to clinical norms.
Measured: 18 months
ongoing pregnancy rate
compare success to clinical norms
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servy Massey Fertility Insititute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joe B Massey, MD, Study chair, Servy Massey Fertilty Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986374
- Sponsor's protocol ID
- HCG 2013
- Status last verified
- Nov 2013
- First submitted
- 11 Nov 2013
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Mansour R, Tawab N, Kamal O, El-Faissal Y, Serour A, Aboulghar M, Serour G. Intrauterine injection of human chorionic gonadotropin before embryo transfer significantly improves the implantation and pregnancy rates in in vitro fertilization/intracytoplasmic sperm injection: a prospective randomized study. Fertil Steril. 2011 Dec;96(6):1370-1374.e1. doi: 10.1016/j.fertnstert.2011.09.044. Epub 2011 Nov 1.
PubMed 22047664Zarei A, Parsanezhad ME, Younesi M, Alborzi S, Zolghadri J, Samsami A, Amooee S, Aramesh S. Intrauterine administration of recombinant human chorionic gonadotropin before embryo transfer on outcome of in vitro fertilization/ intracytoplasmic sperm injection: A randomized clinical trial. Iran J Reprod Med. 2014 Jan;12(1):1-6.
PubMed 24799855Santibanez A, Garcia J, Pashkova O, Colin O, Castellanos G, Sanchez AP, De la Jara JF. Effect of intrauterine injection of human chorionic gonadotropin before embryo transfer on clinical pregnancy rates from in vitro fertilisation cycles: a prospective study. Reprod Biol Endocrinol. 2014 Jan 29;12:9. doi: 10.1186/1477-7827-12-9.
PubMed 24476536Hong 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 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Injection of Human Chorionic Gonadotropin to Enhance Embryo Implantation
- ClinicalTrials.gov ID
- NCT01986374
- Acronym / sponsor ID
- HCG 2013
- Conditions
- Infertility
- Keywords
- IVF , embryo implantation, HCG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Servy Massey Fertility InsitituteUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 18 Nov 2013 (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.
The endometrium is deprived of signals form the embryo in IVF conditions. Studies suggest that placing HCG into the uterus prior to embryo transfer can enhance implantation.
Detailed description
The study is in pilot phase, uncontrolled. The risks appear to be minimal and there are conflicting new reports being announced.
A small amount of fluid with HCG is injected into the uterus. HCG is a potent signal to the uterus for preparation for implantation.
This is not a funded study. Three published studies suggest the approach is valid; one refutes the concept.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCG is introduced with small catheter. | Experimental | Drug: HCG is introducedphase 1 non randomized pilot |
Who may qualify
- Ages
- 21 to 47 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- infertility patients undergoing IVF with good expectation of two embryos day 3 or day 5. must speak and read English. Includes donor eggs.
Key exclusion criteria (1 listed)
- -
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 is introducedAlso: Improve results of IVF and embryo transfermust have good blastocysts | Drug | HCG is introduced with small catheter. |
Primary outcome
HCG enhances pregnancy rate
Time frame: 9 months.
compare pregnancy rates to established clinical norms.
2 secondary outcomes
implantation rate
Time frame: 18 months
ongoing pregnancy rate
Time frame: 22 months
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 19 Mar 2020.
- Background: PubMed 22047664Mansour R, Tawab N, Kamal O, El-Faissal Y, Serour A, Aboulghar M, Serour G. Intrauterine injection of human chorionic gonadotropin before embryo transfer significantly improves the implantation and pregnancy rates in in vitro fertilization/intracytoplasmic sperm injection: a prospective randomized study. Fertil Steril. 2011 Dec;96(6):1370-1374.e1. doi: 10.1016/j.fertnstert.2011.09.044. Epub 2011 Nov 1.
- Background: PubMed 24799855Zarei A, Parsanezhad ME, Younesi M, Alborzi S, Zolghadri J, Samsami A, Amooee S, Aramesh S. Intrauterine administration of recombinant human chorionic gonadotropin before embryo transfer on outcome of in vitro fertilization/ intracytoplasmic sperm injection: A randomized clinical trial. Iran J Reprod Med. 2014 Jan;12(1):1-6.
- Background: PubMed 24476536Santibanez A, Garcia J, Pashkova O, Colin O, Castellanos G, Sanchez AP, De la Jara JF. Effect of intrauterine injection of human chorionic gonadotropin before embryo transfer on clinical pregnancy rates from in vitro fertilisation cycles: a prospective study. Reprod Biol Endocrinol. 2014 Jan 29;12:9. doi: 10.1186/1477-7827-12-9.
- Background: 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.
Joe B Massey, MD study chair
Servy Massey Fertilty Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HCG is introduced in people with Infertility, run by Servy Massey Fertility Insititute at 1 site 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 1 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 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
HCG enhances pregnancy rate (time frame: 9 months.). 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 NCT01986374, which also lists 4 linked publications.
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 19 Mar 2020.