InfertilityNCT01298128
NuvaRing vs. Oral Contraceptive Pills (OCP) for In-Vitro Fertilization (IVF) Pre-treatment
A study testing NuvaRing and marvelon in people with Infertility and In-vitro Fertilization, run by University of Toronto.
Trial summary
The newly designed contraceptive ring, Nuvaring has a lower total steroid dose, and medications are delivered locally. It has been proven to be as safe and effective as the combined OCP in ovarian suppression and preventing ovulation with fewer side effects due to minimal systemic absorption. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility, In-vitro Fertilization
- What is being tested?
- NuvaRing and marvelon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients less than 38 years of age.
- Healthy women starting their first IVF/ICSI cycle.
- No contraindication to Combined Oral Contraceptive (COC) use. Appendix 1
- Consent to randomization.
Who cannot join
- Any contraindication to COC use.
- Hypersensitivity to Nuva ring or any of its components.
- Language barrier to consent.
About this study
Official title: A Randomized Controlled Trial of NuvaRing® Versus Combined Oral Contraceptive Pills for Pre-treatment in In-Vitro Fertilization (IVF) Cycles
The newly designed contraceptive ring, Nuvaring has a lower total steroid dose, and medications are delivered locally. It has been proven to be as safe and effective as the combined OCP in ovarian suppression and preventing ovulation with fewer side effects due to minimal systemic absorption. Following a single vaginal insertion, steroid concentrations remain stable for up to 4 weeks. It is hypothesized that Nuvaring may, therefore lead to better compliance, tolerability and acceptance by patients requiring ovarian suppression prior to COH for IVF.
- Conditions
- Infertility, In-vitro Fertilization
- Being tested
- NuvaRing, marvelon
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuvaRingDrug
NuvaRIng 21 days for IVF pre-treatment.
marvelonDrug
marvelon 21 daily
| Study group | Role | What they receive |
|---|---|---|
| NuvaRing | Experimental | NuvaRing for IVF pre-treatment Receives: Drug: NuvaRing |
| Combined oral contraceptive pill | Active comparator | OCP for IVF pre-treatment Receives: Drug: marvelon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description)
abnormal bleeding, intermittent bleeding, headache, breast discomfort, bloating, mood swings, nausea, vaginal discharge, vomitting, weight gain
Measured: patients were followed for the duration of an in-vitro fertilization cycle- 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startFeb 2006
- Primary completionMar 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Liu, University of Toronto
- Investigators
- Kimberly E Liu, MD, Principal investigator, Mount Sinai Hospital, Toronto ON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298128
- Sponsor's protocol ID
- CFRH- 001
- Status last verified
- Oct 2012
- First submitted
- 15 Feb 2011
- Last updated
- 5 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Liu KE, Alhajri M, Greenblatt E. A randomized controlled trial of NuvaRing versus combined oral contraceptive pills for pretreatment in in vitro fertilization cycles. Fertil Steril. 2011 Sep;96(3):605-8. doi: 10.1016/j.fertnstert.2011.06.073.
PubMed 21880278
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of NuvaRing® Versus Combined Oral Contraceptive Pills for Pre-treatment in In-Vitro Fertilization (IVF) Cycles
- ClinicalTrials.gov ID
- NCT01298128
- Acronym / sponsor ID
- CFRH- 001
- Conditions
- Infertility, In-vitro Fertilization
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Feb 2011 (estimated)
- Results
- Posted 17 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The newly designed contraceptive ring, Nuvaring has a lower total steroid dose, and medications are delivered locally. It has been proven to be as safe and effective as the combined OCP in ovarian suppression and preventing ovulation with fewer side effects due to minimal systemic absorption. Following a single vaginal insertion, steroid concentrations remain stable for up to 4 weeks. It is hypothesized that Nuvaring may, therefore lead to better compliance, tolerability and acceptance by patients requiring ovarian suppression prior to COH for IVF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NuvaRing | Experimental | Drug: NuvaRingNuvaRing for IVF pre-treatment |
| Combined oral contraceptive pill | Active comparator | Drug: marvelonOCP for IVF pre-treatment |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients less than 38 years of age.
- Healthy women starting their first IVF/ICSI cycle.
- No contraindication to Combined Oral Contraceptive (COC) use. Appendix 1
- Consent to randomization.
Key exclusion criteria (3 listed)
- Any contraindication to COC use.
- Hypersensitivity to Nuva ring or any of its components.
- Language barrier to consent.
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 |
|---|---|---|
| NuvaRingNuvaRIng 21 days for IVF pre-treatment. | Drug | NuvaRing |
| marvelonmarvelon 21 daily | Drug | Combined oral contraceptive pill |
Primary outcome
Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description)
Time frame: patients were followed for the duration of an in-vitro fertilization cycle- 2 months
abnormal bleeding, intermittent bleeding, headache, breast discomfort, bloating, mood swings, nausea, vaginal discharge, vomitting, weight gain
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21880278Liu KE, Alhajri M, Greenblatt E. A randomized controlled trial of NuvaRing versus combined oral contraceptive pills for pretreatment in in vitro fertilization cycles. Fertil Steril. 2011 Sep;96(3):605-8. doi: 10.1016/j.fertnstert.2011.06.073.
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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.
Kimberly E Liu, MD principal investigator
Mount Sinai Hospital, Toronto ON
Questions about this trial
What is this clinical trial studying?
A study testing NuvaRing and marvelon in people with Infertility and In-vitro Fertilization, run by University of Toronto.
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 3 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: stopped early, as of the sponsor's last update on 5 Oct 2012. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description) (time frame: patients were followed for the duration of an in-vitro fertilization cycle- 2 months). 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 NCT01298128, 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 5 Oct 2012.