Female InfertilityPhase 4CLOFANCT01791751
Impact of Clomiphene Citrate Administration During the Early Luteal Phase on Endocrine Profile in IVF Cycles
A Phase 4 study testing Clomifene Citrate in people with Female Infertility, run by Fundació Privada Eugin at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the effect on LH levels of the 5-day CC administration during luteal phase in oocyte donors, to investigate whether the CC corrects the suppressed LH levels in the luteal phase and whether it prolongs the luteal phase in the agonist triggered antagonist cycles. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Infertility
- What is being tested?
- Clomifene Citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2012to Feb 2013
- Phase
- Phase 4
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Oocyte donors
- 18-35 years old
- BMI 18-29 Kg/m2
- Normal basal hormonal levels
- No contraceptive pill
Who cannot join
- Polycystic ovarian syndrome (PCOS)
- Previous participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Clomiphene Citrate Administration During the Early Luteal Phase on Endocrine Profile in Agonist Triggered GnRH Antagonist in Vitro Fertilization Cycles. Phase IV, Single-centre, Open-label, Controlled Clinical Trial.
The purpose of this study is to evaluate the effect on LH levels of the 5-day CC administration during luteal phase in oocyte donors, to investigate whether the CC corrects the suppressed LH levels in the luteal phase and whether it prolongs the luteal phase in the agonist triggered antagonist cycles.
- Conditions
- Female Infertility
- Being tested
- Clomifene Citrate
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomifene CitrateDrug
Clomiphene citrate 100 mg daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Clomifene Citrate | Experimental | Clomifene Citrate 50 mg Receives: Drug: Clomifene Citrate |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
LH Levels (IU)
Measured: Luteal phase (up to 2 weeks)
Secondary outcomes (1)
Endometrial development (Noyes criteria)
Measured: Luteal phase (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startJun 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Privada Eugin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Colodron, MD, Principal investigator, Clinica EUGIN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791751
- Sponsor's protocol ID
- CLOFA
- Other IDs
- 2011-002173-33
- Acronym
- CLOFA
- Status last verified
- Feb 2013
- First submitted
- 12 Nov 2012
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Clomiphene Citrate Administration During the Early Luteal Phase on Endocrine Profile in Agonist Triggered GnRH Antagonist in Vitro Fertilization Cycles. Phase IV, Single-centre, Open-label, Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT01791751
- Acronym / sponsor ID
- CLOFA / CLOFA
- Conditions
- Female Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fundació Privada EuginUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 Feb 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 purpose of this study is to evaluate the effect on LH levels of the 5-day CC administration during luteal phase in oocyte donors, to investigate whether the CC corrects the suppressed LH levels in the luteal phase and whether it prolongs the luteal phase in the agonist triggered antagonist cycles.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clomifene Citrate | Experimental | Drug: Clomifene CitrateClomifene Citrate 50 mg |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Oocyte donors
- 18-35 years old
- BMI 18-29 Kg/m2
- Normal basal hormonal levels
- No contraceptive pill
Key exclusion criteria (2 listed)
- Polycystic ovarian syndrome (PCOS)
- Previous participation in the study
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 |
|---|---|---|
| Clomifene CitrateClomiphene citrate 100 mg daily for 5 days | Drug | Clomifene Citrate |
Primary outcome
LH Levels (IU)
Time frame: Luteal phase (up to 2 weeks)
1 secondary outcome
Endometrial development (Noyes criteria)
Time frame: Luteal phase (1 day)
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 15 Feb 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.
Marta Colodron, MD principal investigator
Clinica EUGIN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clomifene Citrate in people with Female Infertility, run by Fundació Privada Eugin at 1 site in Spain.
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 5 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 15 Feb 2013. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
LH Levels (IU) (time frame: Luteal phase (up to 2 weeks)). 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 15 Feb 2013.