InfertilityNCT02668965
The Effects of Intrauterine Infusion of hCG at the Time of Embryo Transfer
A study testing Intrauterine hCG (pregnyl) in people with Infertility, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether intrauterine hCG can improve the implantation rate and clinical pregnancy rate after embryo transfer in IVF/ICSI cycle. 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
- Infertility
- What is being tested?
- Intrauterine hCG (pregnyl)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2015to Apr 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 18 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- infertile women aged 18-43 years
- indicated or willing for IVF/ICSI treatment or endometrial preparation for embryo transfer
Who cannot join
- Azoospermic male partner
- Failure to retrieve oocyte after controlled ovarian hyperstimulation
- No embryo retrieved for transfer
- Endometrial preparation failure
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Infertility unit, Siriraj Hospital
Bangkok, Bangkok, 10700
savinee boonsuk, M.D., +66818706643, noomnim_mu@hotmail.com
Pitak Laokrikkiat, M.D., +66890009977, siplo@mahidol.ac.th
About this study
Official title: The Effects of Intrauterine Infusion of Human Chorionic Gonadotropin at the Time of Embryo Transfer on IVF/ICSI Outcomes: Randomized, Double-blind Controlled Study
The purpose of this study is to determine whether intrauterine hCG can improve the implantation rate and clinical pregnancy rate after embryo transfer in IVF/ICSI cycle.
Read the detailed description
Patients at infertility clinic, siriraj hospital who come to start IVF/ICSI treatment cycle or endometrial preparation for embryo transfer are consiferes as eligible subjects.
On the day of embryo transfer (both fresh and frozen-thaw cycle), the subjects will be randomized to 2 groups.
- control group: embryo transfer after intrauterine infusion with standard embryo culture media 4-7 minutes
- study group: embryo transfer after intrauterine infusion with hCG (Pregnyl) 4-7 minutes
The patients will come back for serum beta-hCG measurement 2 weeks later after embryo transfer and other 2 weeks later for transvaginal ultrasound if beta-hCG is positive.
- Conditions
- Infertility
- Being tested
- Intrauterine hCG (pregnyl)
- Keywords
- Clinical pregnancy rate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine hCG (pregnyl)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | intrauterine infusion with standard embryo culture media 10 microliters before embryo transfer |
| intrauterine hCG | Experimental | intrauterine infusion with hCG (500 IU) 10 microliters before embryo transfer Receives: Procedure: Intrauterine hCG (pregnyl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Transvaginal ultrasound to confirm number of intrauterine gestational sac and fetal heart beats
Measured: 2 weeks after positive serum beta-hCG
Secondary outcomes (2)
Chemical pregnancy rate
positive serum beta-hCG more than 3
Measured: 2 weeks after embryo transfer
Implantation rate
number of intrauterine gestational sac / number of embryo transferred
Measured: 2 weeks after positive serum beta-hCG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionMar 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savinee Boonsuk, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668965
- Sponsor's protocol ID
- Si701/2015
- Status last verified
- Jan 2016
- First submitted
- 27 Jan 2016
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intrauterine Infusion of Human Chorionic Gonadotropin at the Time of Embryo Transfer on IVF/ICSI Outcomes: Randomized, Double-blind Controlled Study
- ClinicalTrials.gov ID
- NCT02668965
- Acronym / sponsor ID
- Si701/2015
- Conditions
- Infertility
- Keywords
- Clinical pregnancy rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 29 Jan 2016 (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 purpose of this study is to determine whether intrauterine hCG can improve the implantation rate and clinical pregnancy rate after embryo transfer in IVF/ICSI cycle.
Detailed description
Patients at infertility clinic, siriraj hospital who come to start IVF/ICSI treatment cycle or endometrial preparation for embryo transfer are consiferes as eligible subjects.
On the day of embryo transfer (both fresh and frozen-thaw cycle), the subjects will be randomized to 2 groups.
- control group: embryo transfer after intrauterine infusion with standard embryo culture media 4-7 minutes
- study group: embryo transfer after intrauterine infusion with hCG (Pregnyl) 4-7 minutes
The patients will come back for serum beta-hCG measurement 2 weeks later after embryo transfer and other 2 weeks later for transvaginal ultrasound if beta-hCG is positive.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –intrauterine infusion with standard embryo culture media 10 microliters before embryo transfer |
| intrauterine hCG | Experimental | Procedure: Intrauterine hCG (pregnyl)intrauterine infusion with hCG (500 IU) 10 microliters before embryo transfer |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- infertile women aged 18-43 years
- indicated or willing for IVF/ICSI treatment or endometrial preparation for embryo transfer
Key exclusion criteria (4 listed)
- Azoospermic male partner
- Failure to retrieve oocyte after controlled ovarian hyperstimulation
- No embryo retrieved for transfer
- Endometrial preparation failure
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 |
|---|---|---|
| Intrauterine hCG (pregnyl) | Procedure or surgery | intrauterine hCG |
Primary outcome
Clinical pregnancy rate
Time frame: 2 weeks after positive serum beta-hCG
Transvaginal ultrasound to confirm number of intrauterine gestational sac and fetal heart beats
2 secondary outcomes
Chemical pregnancy rate
Time frame: 2 weeks after embryo transfer
Implantation rate
Time frame: 2 weeks after positive serum beta-hCG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrauterine hCG (pregnyl) in people with Infertility, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Jan 2016. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact savinee boonsuk, M.D. (+66818706643, noomnim_mu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 2 weeks after positive serum beta-hCG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2016.