Sub-FertilityEarly Phase 1NCT02994550
Influence of FSH/LH Ratio in Controlled Ovarian Stimulation
A Early Phase 1 study testing FSH/LH in people with Sub-Fertility, run by Hospital de Cruces.
Trial summary
The aim of this study is to compare different FSH/LH ratios in controlled ovarian stimulation Read more about this study
- Who is it for?
- Ages 35 to 40 years, women only
- Conditions the study is for
- Sub-Fertility
- What is being tested?
- FSH/LH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 447 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2018
- Phase
- Early Phase 1
- 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 35 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing IVF cycles in Cruces University Hospital.
- Signed IVF and cryopreservation informed consent.
- Age >35 and <40 years.
- FSH levels <10 mIU/ml.
Who cannot join
- When inclusion criteria are not fulfilled
About this study
Official title: Influence of FSH/LH Ratio in Controlled Ovarian Stimulation ( 2/1 Ratio vs 4/1 Ratio) in >35 Years Women Undergoing IVF
The aim of this study is to compare different FSH/LH ratios in controlled ovarian stimulation
- Conditions
- Sub-Fertility
- Being tested
- FSH/LH
- Keywords
- FSH, LH, IVF
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSH/LHDrug
| Study group | Role | What they receive |
|---|---|---|
| FSH/LH 2/1 | Experimental | dose: 300IU FSHrec and 150IU LHrec Receives: Drug: FSH/LH |
| FSH/LH 4/1 | Experimental | dose: 300IU FSHrec and 75IU LHrec Receives: Drug: FSH/LH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy achievement
To report our results in terms of pregnancy per embryo transfer
Measured: 3 months after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sub-FertilityStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Cruces
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonia Exposito, Hospital de Cruces
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994550
- Sponsor's protocol ID
- CEIC E14/30
- Status last verified
- Aug 2022
- First submitted
- 1 Dec 2016
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of FSH/LH Ratio in Controlled Ovarian Stimulation ( 2/1 Ratio vs 4/1 Ratio) in >35 Years Women Undergoing IVF
- ClinicalTrials.gov ID
- NCT02994550
- Acronym / sponsor ID
- CEIC E14/30
- Conditions
- Sub-Fertility
- Keywords
- FSH, LH, IVF
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- Hospital de CrucesUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 16 Dec 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 aim of this study is to compare different FSH/LH ratios in controlled ovarian stimulation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FSH/LH 2/1 | Experimental | Drug: FSH/LHdose: 300IU FSHrec and 150IU LHrec |
| FSH/LH 4/1 | Experimental | Drug: FSH/LHdose: 300IU FSHrec and 75IU LHrec |
Who may qualify
- Ages
- 35 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients undergoing IVF cycles in Cruces University Hospital.
- Signed IVF and cryopreservation informed consent.
- Age >35 and <40 years.
- FSH levels <10 mIU/ml.
Key exclusion criteria (1 listed)
- When inclusion criteria are not fulfilled
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 |
|---|---|---|
| FSH/LH | Drug | FSH/LH 2/1, FSH/LH 4/1 |
Primary outcome
Pregnancy achievement
Time frame: 3 months after drug administration
To report our results in terms of pregnancy per embryo transfer
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 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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 Early Phase 1 study testing FSH/LH in people with Sub-Fertility, run by Hospital de Cruces.
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 Aug 2022. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pregnancy achievement (time frame: 3 months after drug administration). 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 Aug 2022.