InfertilityNCT01892826
Frozen Blastocyst Transfer in Natural Cycle
A study testing hCG in people with Infertility, run by Universitair Ziekenhuis Brussel.
Trial summary
The rational of the study is to assess the pregnancy rate after the transfer of frozen blastocyst in natural cycle controlled by external administration of hCG. Read more about this study
- Who is it for?
- Ages 17 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- hCG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Mar 2013
- 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 17 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age < 40
- BMI:18-29 kg/m2
- day 5 frozen embryo
- previously IVF/ICSI
Who cannot join
- OOCYTE DONATION CYCLES
About this study
Official title: Cryopreserved Thawed Blastocyst Transfer in Natural Cycle With or Without hCG Administration
The rational of the study is to assess the pregnancy rate after the transfer of frozen blastocyst in natural cycle controlled by external administration of hCG.
- Conditions
- Infertility
- Being tested
- hCG
- Keywords
- FET, Blastocyst, natural cycle, hCG, Spontaneous LH pic
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hCGDrug
5000IU
| Study group | Role | What they receive |
|---|---|---|
| hCG group | Experimental | Not described Receives: Drug: hCG |
| LH pic | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation rate
Measured: 2 years
Secondary outcomes (1)
ongoing pregnancy rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startFeb 2009
- Primary completionFeb 2012
- Study completionMar 2013
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 Universitair Ziekenhuis BrusselThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyrou Dimitra, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892826
- Sponsor's protocol ID
- TC8851
- Status last verified
- Jul 2013
- First submitted
- 1 Jul 2013
- Last updated
- 4 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryopreserved Thawed Blastocyst Transfer in Natural Cycle With or Without hCG Administration
- ClinicalTrials.gov ID
- NCT01892826
- Acronym / sponsor ID
- TC8851
- Conditions
- Infertility
- Keywords
- FET, Blastocyst, natural cycle, hCG, Spontaneous LH pic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Jul 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 rational of the study is to assess the pregnancy rate after the transfer of frozen blastocyst in natural cycle controlled by external administration of hCG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hCG group | Experimental | Drug: hCG |
| LH pic | No intervention | – |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- age < 40
- BMI:18-29 kg/m2
- day 5 frozen embryo
- previously IVF/ICSI
Key exclusion criteria (1 listed)
- OOCYTE DONATION CYCLES
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 |
|---|---|---|
| hCG5000IU | Drug | hCG group |
Primary outcome
Implantation rate
Time frame: 2 years
1 secondary outcome
ongoing pregnancy rate
Time frame: 2 years
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 4 Jul 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing hCG in people with Infertility, run by Universitair Ziekenhuis Brussel.
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 4 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 4 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Implantation rate (time frame: 2 years). 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 4 Jul 2013.