InfertilityFRETNCT00809107
Frozen Embryo Transfer (FET) in Natural Cycles or in Natural Cycles Controlled by Human Chorionic Gonadotropin (hCG) Administration
A study testing HCG in people with Infertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The rational of the study is to assess the implantation, pregnancy and live birth rates after the transfer of frozen- thawed embryos in natural cycles with spontaneous Luteinizing Hormone (LH)/Progesterone rise or in natural cycles controlled by human chorionic gonadotropin (hCG) for final oocyte maturation and… 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
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2006to Jan 2009
- 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:18-29Kg/m2
- day 3 embryo transfers
- previously IVF or ICSI
Who cannot join
- irregular cycles
- oocyte donation cycles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cryopreserved-Thawed Embryo Transfer in Natural Cycle or in Natural Cycles Controlled by External Administration of hCG: a Prospective Randomized Study
The rational of the study is to assess the implantation, pregnancy and live birth rates after the transfer of frozen- thawed embryos in natural cycles with spontaneous Luteinizing Hormone (LH)/Progesterone rise or in natural cycles controlled by human chorionic gonadotropin (hCG) for final oocyte maturation and ovulation.
- Conditions
- Infertility
- Being tested
- HCG
- Keywords
- natural cycle, FET, spontaneous LH pic, HCG
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCGDrug
Also called pregnyl
5000IU
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | HCG GROUP Receives: Drug: HCG |
| 2 | No intervention | LH pick |
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 posted17 Dec 2008 (estimated)
- Study startOct 2006
- Primary completionJul 2008
- Study completionJan 2009
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809107
- Sponsor's protocol ID
- TC3471
- Acronym
- FRET
- Status last verified
- Feb 2009
- First submitted
- 16 Dec 2008
- Last updated
- 19 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Gelbaya TA, Nardo LG, Hunter HR, Fitzgerald CT, Horne G, Pease EE, Brison DR, Lieberman BA. Cryopreserved-thawed embryo transfer in natural or down-regulated hormonally controlled cycles: a retrospective study. Fertil Steril. 2006 Mar;85(3):603-9. doi: 10.1016/j.fertnstert.2005.09.015.
PubMed 16500326
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryopreserved-Thawed Embryo Transfer in Natural Cycle or in Natural Cycles Controlled by External Administration of hCG: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT00809107
- Acronym / sponsor ID
- FRET / TC3471
- Conditions
- Infertility
- Keywords
- natural cycle, FET, spontaneous LH pic, HCG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 17 Dec 2008 (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 implantation, pregnancy and live birth rates after the transfer of frozen- thawed embryos in natural cycles with spontaneous Luteinizing Hormone (LH)/Progesterone rise or in natural cycles controlled by human chorionic gonadotropin (hCG) for final oocyte maturation and ovulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: HCGHCG GROUP |
| 2 | No intervention | –LH pick |
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:18-29Kg/m2
- day 3 embryo transfers
- previously IVF or ICSI
Key exclusion criteria (2 listed)
- irregular cycles
- 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 |
|---|---|---|
| HCGAlso: pregnyl5000IU | Drug | 1 |
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 19 Feb 2009.
- Background: PubMed 16500326Gelbaya TA, Nardo LG, Hunter HR, Fitzgerald CT, Horne G, Pease EE, Brison DR, Lieberman BA. Cryopreserved-thawed embryo transfer in natural or down-regulated hormonally controlled cycles: a retrospective study. Fertil Steril. 2006 Mar;85(3):603-9. doi: 10.1016/j.fertnstert.2005.09.015.
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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.
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 in people with Infertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 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 19 Feb 2009. 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 Belgium. 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?
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?
On the ClinicalTrials.gov record for NCT00809107, 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 19 Feb 2009.