InfertilityLargantaNCT01157754
Oral Contraceptive Pill and GnRH Antagonist Versus Long Protocol in IVF Patients
A study testing levonorgestrel and ethynilestradiol in people with Infertility, run by IVI Madrid at 1 site in Spain.
Trial summary
Recent controversy has arisen regarding the use of the pill for cycle planning in GnRH antagonist IVF cycles. The investigators performed this study to compare such a protocol with the gold-standard still today, which is the long-agonist protocol with no previous use of the pill. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- levonorgestrel and ethynilestradiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2009to Jun 2010
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1st or 2nd IVF cycle
- BMI <30 kg/m2
- regular menstrual cycles
- basal FSH <10 IU and E2 <60 pg/ml
Who cannot join
- Polycystic ovaries
- endometriosis
- previous ovarian surgery
- previous low ovarian response
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cycle Planning With OCP in GnRH Antagonists Cycles Versus Long Protocol in Good Prognosis IVF Patients
Recent controversy has arisen regarding the use of the pill for cycle planning in GnRH antagonist IVF cycles. The investigators performed this study to compare such a protocol with the gold-standard still today, which is the long-agonist protocol with no previous use of the pill.
- Conditions
- Infertility
- Being tested
- levonorgestrel and ethynilestradiol
- Keywords
- Infertility patients requiring IVF, good prognosis
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levonorgestrel and ethynilestradiolDrug
| Study group | Role | What they receive |
|---|---|---|
| OCP+GnRH antagonist | Experimental | Microgynon 14 to 21 tablets starting COH on day 5 post pill, rFSH + GnRH antagonist Receives: Drug: levonorgestrel and ethynilestradiol |
| long GnRH agonist | Active comparator | daily triptorelin starting day 21st of previous cycle Receives: Drug: levonorgestrel and ethynilestradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
implantation rate
Measured: 2 weeks after the embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startJun 2009
- Primary completionMay 2010
- Study completionJun 2010
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.
- 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
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157754
- Sponsor's protocol ID
- MAD-GV-05-2009-01
- Acronym
- Larganta
- Status last verified
- Apr 2015
- First submitted
- 6 Jul 2010
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cycle Planning With OCP in GnRH Antagonists Cycles Versus Long Protocol in Good Prognosis IVF Patients
- ClinicalTrials.gov ID
- NCT01157754
- Acronym / sponsor ID
- Larganta / MAD-GV-05-2009-01
- Conditions
- Infertility
- Keywords
- Infertility patients requiring IVF, good prognosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 7 Jul 2010 (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.
Recent controversy has arisen regarding the use of the pill for cycle planning in GnRH antagonist IVF cycles. The investigators performed this study to compare such a protocol with the gold-standard still today, which is the long-agonist protocol with no previous use of the pill.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCP+GnRH antagonist | Experimental | Drug: levonorgestrel and ethynilestradiolMicrogynon 14 to 21 tablets starting COH on day 5 post pill, rFSH + GnRH antagonist |
| long GnRH agonist | Active comparator | Drug: levonorgestrel and ethynilestradioldaily triptorelin starting day 21st of previous cycle |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1st or 2nd IVF cycle
- BMI <30 kg/m2
- regular menstrual cycles
- basal FSH <10 IU and E2 <60 pg/ml
Key exclusion criteria (4 listed)
- Polycystic ovaries
- endometriosis
- previous ovarian surgery
- previous low ovarian response
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 |
|---|---|---|
| levonorgestrel and ethynilestradiol | Drug | OCP+GnRH antagonist, long GnRH agonist |
Primary outcome
implantation rate
Time frame: 2 weeks after the 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 22 Apr 2015.
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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 levonorgestrel and ethynilestradiol in people with Infertility, run by IVI Madrid 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 4 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: finished, as of the sponsor's last update on 22 Apr 2015. 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.
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 weeks after the embryo transfer). 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 22 Apr 2015.