InfertilityPhase 4NCT01501448
Oral Estradiol Valerate Versus Oral Contraceptive Pill in Invitro Fertilization Patients
A Phase 4 study testing Levonorgestrel and ethinylestradiol and Estradiol valerate in people with Infertility, run by IVI Madrid at 1 site in Spain.
Trial summary
The recent controversy regarding the use of pill for cycle planning in GnRH antagonists IVF cycle has driven the search for new ways to plan IVF cycles in order to avoid weekends or to equally distribute the workload. Recently, mid-late luteal phase oral estrogens seem to be as good as 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 ethinylestradiol and Estradiol valerate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteSpain
- Study dates
- Jan 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 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 <10IU and E2 <60pg/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
The recent controversy regarding the use of pill for cycle planning in GnRH antagonists IVF cycle has driven the search for new ways to plan IVF cycles in order to avoid weekends or to equally distribute the workload. Recently, mid-late luteal phase oral estrogens seem to be as good as the pill. The investigators will compare OCP vs oral estrogens to plan the initiation of IVF cycles.
- Conditions
- Infertility
- Being tested
- Levonorgestrel and ethinylestradiol, Estradiol valerate
- 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 ethinylestradiolDrug
30 microgram of ethinylestradiol plus levonorgestrel daily for 12 to 16 days
Estradiol valerateDrug
4mg estradiol valerate from cycle day 20 till the day before the initiation of the cycle
| Study group | Role | What they receive |
|---|---|---|
| OCP | Active comparator | Not described Receives: Drug: Levonorgestrel and ethinylestradiol |
| Oral estradiol valerate | Active comparator | Not described Receives: Drug: Estradiol valerate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation rate
number of embryonic sacs visible by ultrasound divided by the number of embryos transferred
Measured: 20 days 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 posted29 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionFeb 2013
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 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
- NCT01501448
- Sponsor's protocol ID
- IVIMAD-GV-OCPE-2011
- Status last verified
- Mar 2016
- First submitted
- 27 Dec 2011
- Last updated
- 22 Mar 2016
- Results posted
- No
Publications
Hauzman EE, Zapata A, Bermejo A, Iglesias C, Pellicer A, Garcia-Velasco JA. Cycle scheduling for in vitro fertilization with oral contraceptive pills versus oral estradiol valerate: a randomized, controlled trial. Reprod Biol Endocrinol. 2013 Sep 28;11:96. doi: 10.1186/1477-7827-11-96.
PubMed 24074027
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Estradiol Valerate Versus Oral Contraceptive Pill in Invitro Fertilization Patients
- ClinicalTrials.gov ID
- NCT01501448
- Acronym / sponsor ID
- IVIMAD-GV-OCPE-2011
- Conditions
- Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 29 Dec 2011 (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 recent controversy regarding the use of pill for cycle planning in GnRH antagonists IVF cycle has driven the search for new ways to plan IVF cycles in order to avoid weekends or to equally distribute the workload. Recently, mid-late luteal phase oral estrogens seem to be as good as the pill. The investigators will compare OCP vs oral estrogens to plan the initiation of IVF cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCP | Active comparator | Drug: Levonorgestrel and ethinylestradiol |
| Oral estradiol valerate | Active comparator | Drug: Estradiol valerate |
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 <10IU and E2 <60pg/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 ethinylestradiol30 microgram of ethinylestradiol plus levonorgestrel daily for 12 to 16 days | Drug | OCP |
| Estradiol valerate4mg estradiol valerate from cycle day 20 till the day before the initiation of the cycle | Drug | Oral estradiol valerate |
Primary outcome
Implantation rate
Time frame: 20 days after the embryo transfer
number of embryonic sacs visible by ultrasound divided by the number of embryos transferred
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 Mar 2016.
- Derived from this study: PubMed 24074027Hauzman EE, Zapata A, Bermejo A, Iglesias C, Pellicer A, Garcia-Velasco JA. Cycle scheduling for in vitro fertilization with oral contraceptive pills versus oral estradiol valerate: a randomized, controlled trial. Reprod Biol Endocrinol. 2013 Sep 28;11:96. doi: 10.1186/1477-7827-11-96.
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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 Phase 4 study testing Levonorgestrel and ethinylestradiol and Estradiol valerate 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 Mar 2016. 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?
Implantation rate (time frame: 20 days after the embryo transfer). 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 NCT01501448, 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 22 Mar 2016.