InfertilityPhase 4NCT01638767
NuvaRing Versus Marvelon in the Coordination of In Vitro Fertilization Cycles
A Phase 4 study testing Contraceptives, Oral and Contraceptive, Vaginal ring in people with Infertility, run by Clinique Ovo at 1 site in Canada.
Trial summary
Presently, a long protocol in an In Vitro Fertilization (IVF) cycle, patients need to take Marvelon, a drug that inhibits the follicular development at the beginning of the cycle in order to better control and also plan the onset of the ovary stimulation with gonadotropin. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Contraceptives, Oral and Contraceptive, Vaginal ring
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2012to Jul 2014
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Signed consent form
- Age 18 or above at the time of selection
- In Vitro Fertilization referral
- Complete and normal pre-In Vitro Fertilization check-up
- Long protocol prescription
- No previous participation in the project during a previous cycle
Who cannot join
- Simultaneous participation in another interventional research project
- Contraindications of being pregnant or carrying a pregnancy to full term
- Contraindications of taking standard medication for long protocol
- Contraindications of taking Marvelon or using NuvaRing (Uncontrolled high blood pressure, uncontrolled diabetes, active hepatic infection, benign or malignant hepatic tumors, diagnosed breast cancer, diagnosed or suspected estrogen-dependant neoplasia, ocular or suspected lesion, history of thrombophlebitis, cardiac arrest, coronary heart disease.)
- Patient presenting vaginal abnormalities could be unable to insert the NuvaRing
- Cervicitis, vaginitis, erosio portionis bleeding, cervical prolapse, cystocele, rectocele, severe or chronic constipation, dyspareunia or other problems with sexual intercourse
Show all 27Show fewer
- Patient having received research medication 30 days before visit 1
- Patient is unable to communicate adequately with researchers
- Patient is incapable of giving informed consent
- Any ovarian or abdominal abnormalities could interfere with an adequate sonographic evaluation
- Use of the following medication:
- Clonidine
- Anticoagulants (before the anovulant pre-treatment)
- Anticonvulsants
- Oral or insulin hypoglycemia drugs
- Hypertension drugs (beta blockers)
- Aminocaproic acid
- Beta mimetics (isoproterenol)
- Prednisone
- Ciclosporin
- Meperidine
- Phenothiazine and reserpine
- Chlordiazepoxide, Lorazepam, Oxazepam, Diazepam (during the anovulant pre-treatment)
- Theophylline
- Clomipramine
- Vitamin B12
- Hypericum perforatum-based products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Using the Nuvaring on the Level of Satisfaction, Stress on Users and on Coordinating In Vitro Fertilization (IVF) Cycles: Randomized Public Study
Presently, a long protocol in an In Vitro Fertilization (IVF) cycle, patients need to take Marvelon, a drug that inhibits the follicular development at the beginning of the cycle in order to better control and also plan the onset of the ovary stimulation with gonadotropin.
Marvelon is taken daily as soon as menstruation starts for a period of 14 to 21 days. Ideally, it has to be taken at the same time everyday and not be forgotten. This may cause higher stress level for some users. Presently on the market, there is a ring-shaped contraceptive device inserted in the vagina at day 1 of the cycle called NuvaRing. The purpose of this device is similar to an oral contraceptive. However, the benefit of NuvaRing is that it can be left in place for a period of up to 35 days without any other manipulation and keep an adequate rate of hormone for contraception. Moreover, NuvaRing shows better hormone stability in the blood. Although the side effects and the benefits are comparable for the two treatments, some studies have shown that more patients would respect the treatment with NuvaRing and that the level of satisfaction would be higher in women using NuvaRing when contraception is needed.
The purpose of the study is to compare the rate of satisfaction as well as the level of stress in women using Marvelon daily or NuvaRing with single insertion in a long protocol. Moreover, this study allow us to verify if using NuvaRing, a vaginal contraceptive releasing constant daily doses for up to 35 days will allow us to facilitate the planning of In Vitro Fertilization cycles in long protocol.
Read the detailed description
For the purpose of this randomized, controlled, open-label study, women will be selected from those undergoing in vitro fertilization treatments with a long protocol prescription. This study will compare two treatment groups, one using Marvelon, the other using the NuvaRing. Patients on Marvelon will be taking the medication for a period ranging from 14 to 21 days. This period will be determined by the administrative nurse. In contrast, patients in the NuvaRing group will be inserting the vaginal ring for a period specified by the administrative nurse, ranging from 14 to 35 days.
During the medical consultation, the couple will be assessed and a primary or secondary infertility diagnosis will be established. Before treatment starts, the couple will have to undergo a series of tests as per the standard of care in order to allow a diagnosis to be made and to determine whether In Vitro Fertilization is the right treatment. The couple will receive all the information they need on an In Vitro Fertilization cycle. If the patient is eligible for In Vitro Fertilization cycle according to initial assessment of the physician, the patient will be informed by the physician about the research project. After a period of consideration and once their questions have been answered, the couple will sign a consent form to start In Vitro Fertilization treatment under the study protocol
After signing the consent form, if the subject is eligible for the research project, the research nurse will meet with the patient. The study will be explained in detail and all questions will be answered. In addition, the nurse will record any information on the patient's medical history including medical history, medication and any previous surgery. The subject will be screened for eligibility prior to randomization. Once the subject is deemed eligible and is interested in participating in the study, the research nurse will meet with the subject in order to sign the informed consent form and to determine the randomization group she will be participating in. In order to determine which group will be allocated for a subject, a randomized envelope will be given to the patient containing the patient number will be opened to assign her to one of the two groups - either the Marvelon or the NuvaRing group. She will open it on site The randomization will be carried out using an envelope system to be identified initially by its randomization number. The envelopes will be prepared in advance in such a way that nobody can know their content.
- Conditions
- Infertility
- Being tested
- Contraceptives, Oral, Contraceptive, Vaginal ring
- Keywords
- In Vitro Fertilization long protocol, NuvaRing, Marvelon, In vitro fertilization
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contraceptives, OralDrug
Also called Marvelon
0.150 mg desogestrel and 0.030 mg ethinyl estradiol tablets, USP. One tablet per day at the same time each day, from the beginning of the menstrual cycle.
Contraceptive, Vaginal ringDrug
Also called NuvaRing
etogestrel/ ethinyl estradiol slow release vaginal ring (11.4 mg/2.6 mg) to deliver 120 mcg etonogestrel/15 mcg ethinyl estradiol per day
| Study group | Role | What they receive |
|---|---|---|
| NuvaRing | Experimental | Patients in the NuvaRing group will be inserting the vaginal ring for a period specified by the administrative nurse, ranging from 14 to 35 days. Receives: Drug: Contraceptive, Vaginal ring |
| Marvelon | Active comparator | Patients on Marvelon will be taking the medication for a period ranging from 14 to 21 days. This period will be determined by the administrative nurse. Receives: Drug: Contraceptives, Oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of satisfaction in patients in relation to contraceptive medication
Measured: From date of the beginning of the In Vitro Fertilization cycle until the end of the cycle, assesses up to 65 days.
The level of stress experienced by patients in relation to contraceptive medication
Measured: From date of the beginning of the In Vitro Fertilization cycle until the end of the cycle, assesses up to 65 days.
Patient's adherence to the treatment
Measured: From date of the beginning of the In Vitro Fertilization cycle until the end of the cycle, assesses up to 65 days.
The number of patients who had bleeding during their contraceptive treatment
Measured: From date of the beginning of the In Vitro Fertilization cycle until the end of the cycle, assesses up to 65 days.
The level of satisfaction among administrative nurses in regards to planning the cycle.
Measured: From date of the beginning of the In Vitro Fertilization cycle until the end of the cycle, assesses up to 65 days.
Secondary outcomes (5)
The number of follicles at the last sonogram before the Human chorionic gonadotropin (hCG) injection
Measured: At time of the last sonogram before the Human chorionicgonadotropin (hCG) injection, approximately 20 days
The presence of cysts (diameter ≥ 15 mm)
Measured: From date of the beginning of the In Vitro Fertilization cycle until the end of the cycle, assesses up to 65 days.
The number of mature ova recovered
Measured: At the time of ova retrieval, approximately 20 days
The number of usable embryos
Measured: From the time of ova retrieval until the time of embryo transfer, up to 5 days.
The pregnancy rates
Measured: At the time of the pregnancy test, approximately 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Difficulty to recruit patient due to lack of eligible patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Ovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Jacques Kadoch, MD, Principal investigator, Clinique Ovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638767
- Sponsor's protocol ID
- OVO-10-03
- Status last verified
- Jul 2015
- First submitted
- 6 Jul 2012
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Timmer CJ, Mulders TM. Pharmacokinetics of etonogestrel and ethinylestradiol released from a combined contraceptive vaginal ring. Clin Pharmacokinet. 2000 Sep;39(3):233-42. doi: 10.2165/00003088-200039030-00005.
PubMed 11020137Roumen FJ, Apter D, Mulders TM, Dieben TO. Efficacy, tolerability and acceptability of a novel contraceptive vaginal ring releasing etonogestrel and ethinyl oestradiol. Hum Reprod. 2001 Mar;16(3):469-75. doi: 10.1093/humrep/16.3.469.
PubMed 11228213Novak A, de la Loge C, Abetz L, van der Meulen EA. The combined contraceptive vaginal ring, NuvaRing: an international study of user acceptability. Contraception. 2003 Mar;67(3):187-94. doi: 10.1016/s0010-7824(02)00514-0.
PubMed 12618252
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using the Nuvaring on the Level of Satisfaction, Stress on Users and on Coordinating In Vitro Fertilization (IVF) Cycles: Randomized Public Study
- ClinicalTrials.gov ID
- NCT01638767
- Acronym / sponsor ID
- OVO-10-03
- Conditions
- Infertility
- Keywords
- In Vitro Fertilization long protocol, NuvaRing, Marvelon, In vitro fertilization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty to recruit patient due to lack of eligible patient
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 12 Jul 2012 (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.
Presently, a long protocol in an In Vitro Fertilization (IVF) cycle, patients need to take Marvelon, a drug that inhibits the follicular development at the beginning of the cycle in order to better control and also plan the onset of the ovary stimulation with gonadotropin.
Marvelon is taken daily as soon as menstruation starts for a period of 14 to 21 days. Ideally, it has to be taken at the same time everyday and not be forgotten. This may cause higher stress level for some users. Presently on the market, there is a ring-shaped contraceptive device inserted in the vagina at day 1 of the cycle called NuvaRing. The purpose of this device is similar to an oral contraceptive. However, the benefit of NuvaRing is that it can be left in place for a period of up to 35 days without any other manipulation and keep an adequate rate of hormone for contraception. Moreover, NuvaRing shows better hormone stability in the blood. Although the side effects and the benefits are comparable for the two treatments, some studies have shown that more patients would respect the treatment with NuvaRing and that the level of satisfaction would be higher in women using NuvaRing when contraception is needed.
The purpose of the study is to compare the rate of satisfaction as well as the level of stress in women using Marvelon daily or NuvaRing with single insertion in a long protocol. Moreover, this study allow us to verify if using NuvaRing, a vaginal contraceptive releasing constant daily doses for up to 35 days will allow us to facilitate the planning of In Vitro Fertilization cycles in long protocol.
Detailed description
For the purpose of this randomized, controlled, open-label study, women will be selected from those undergoing in vitro fertilization treatments with a long protocol prescription. This study will compare two treatment groups, one using Marvelon, the other using the NuvaRing. Patients on Marvelon will be taking the medication for a period ranging from 14 to 21 days. This period will be determined by the administrative nurse. In contrast, patients in the NuvaRing group will be inserting the vaginal ring for a period specified by the administrative nurse, ranging from 14 to 35 days.
During the medical consultation, the couple will be assessed and a primary or secondary infertility diagnosis will be established. Before treatment starts, the couple will have to undergo a series of tests as per the standard of care in order to allow a diagnosis to be made and to determine whether In Vitro Fertilization is the right treatment. The couple will receive all the information they need on an In Vitro Fertilization cycle. If the patient is eligible for In Vitro Fertilization cycle according to initial assessment of the physician, the patient will be informed by the physician about the research project. After a period of consideration and once their questions have been answered, the couple will sign a consent form to start In Vitro Fertilization treatment under the study protocol
After signing the consent form, if the subject is eligible for the research project, the research nurse will meet with the patient. The study will be explained in detail and all questions will be answered. In addition, the nurse will record any information on the patient's medical history including medical history, medication and any previous surgery. The subject will be screened for eligibility prior to randomization. Once the subject is deemed eligible and is interested in participating in the study, the research nurse will meet with the subject in order to sign the informed consent form and to determine the randomization group she will be participating in. In order to determine which group will be allocated for a subject, a randomized envelope will be given to the patient containing the patient number will be opened to assign her to one of the two groups - either the Marvelon or the NuvaRing group. She will open it on site The randomization will be carried out using an envelope system to be identified initially by its randomization number. The envelopes will be prepared in advance in such a way that nobody can know their content.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NuvaRing | Experimental | Drug: Contraceptive, Vaginal ringPatients in the NuvaRing group will be inserting the vaginal ring for a period specified by the administrative nurse, ranging from 14 to 35 days. |
| Marvelon | Active comparator | Drug: Contraceptives, OralPatients on Marvelon will be taking the medication for a period ranging from 14 to 21 days. This period will be determined by the administrative nurse. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Signed consent form
- Age 18 or above at the time of selection
- In Vitro Fertilization referral
- Complete and normal pre-In Vitro Fertilization check-up
- Long protocol prescription
Key exclusion criteria (27 listed)
- Simultaneous participation in another interventional research project
- Contraindications of being pregnant or carrying a pregnancy to full term
- Contraindications of taking standard medication for long protocol
- Contraindications of taking Marvelon or using NuvaRing (Uncontrolled high blood pressure, uncontrolled diabetes, active hepatic infection, benign or malignant hepatic tumors, diagnosed breast cancer, diagnosed or suspected estrogen-dependant neoplasia, ocular or suspected lesion, history of thrombophlebitis, cardiac arrest, coronary heart disease.)
- Patient presenting vaginal abnormalities could be unable to insert the NuvaRing
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 |
|---|---|---|
| Contraceptives, OralAlso: Marvelon0.150 mg desogestrel and 0.030 mg ethinyl estradiol tablets, USP. One tablet per day at the same time each day, from the beginning of the menstrual cycle. | Drug | Marvelon |
| Contraceptive, Vaginal ringAlso: NuvaRingetogestrel/ ethinyl estradiol slow release vaginal ring (11.4 mg/2.6 mg) to deliver 120 mcg etonogestrel/15 mcg ethinyl estradiol per day | Drug | NuvaRing |
Primary outcome
The level of satisfaction in patients in relation to contraceptive medication
Time frame: From date of the beginning of the In Vitro Fertilization cycle until the end of the cycle, assesses up to 65 days.
The level of stress experienced by patients in relation to contraceptive medication
Time frame: From date of the beginning of the In Vitro Fertilization cycle until the end of the cycle, assesses up to 65 days.
Patient's adherence to the treatment
Time frame: From date of the beginning of the In Vitro Fertilization cycle until the end of the cycle, assesses up to 65 days.
The number of patients who had bleeding during their contraceptive treatment
Time frame: From date of the beginning of the In Vitro Fertilization cycle until the end of the cycle, assesses up to 65 days.
The level of satisfaction among administrative nurses in regards to planning the cycle.
Time frame: From date of the beginning of the In Vitro Fertilization cycle until the end of the cycle, assesses up to 65 days.
5 secondary outcomes
The number of follicles at the last sonogram before the Human chorionic gonadotropin (hCG) injection
Time frame: At time of the last sonogram before the Human chorionicgonadotropin (hCG) injection, approximately 20 days
The presence of cysts (diameter ≥ 15 mm)
Time frame: From date of the beginning of the In Vitro Fertilization cycle until the end of the cycle, assesses up to 65 days.
The number of mature ova recovered
Time frame: At the time of ova retrieval, approximately 20 days
The number of usable embryos
Time frame: From the time of ova retrieval until the time of embryo transfer, up to 5 days.
The pregnancy rates
Time frame: At the time of the pregnancy test, approximately 20 days
Results and safety
The study was stopped early (reason given: Difficulty to recruit patient due to lack of eligible patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
- Background: PubMed 11020137Timmer CJ, Mulders TM. Pharmacokinetics of etonogestrel and ethinylestradiol released from a combined contraceptive vaginal ring. Clin Pharmacokinet. 2000 Sep;39(3):233-42. doi: 10.2165/00003088-200039030-00005.
- Background: PubMed 11228213Roumen FJ, Apter D, Mulders TM, Dieben TO. Efficacy, tolerability and acceptability of a novel contraceptive vaginal ring releasing etonogestrel and ethinyl oestradiol. Hum Reprod. 2001 Mar;16(3):469-75. doi: 10.1093/humrep/16.3.469.
- Background: PubMed 12618252Novak A, de la Loge C, Abetz L, van der Meulen EA. The combined contraceptive vaginal ring, NuvaRing: an international study of user acceptability. Contraception. 2003 Mar;67(3):187-94. doi: 10.1016/s0010-7824(02)00514-0.
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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.
Jacques Kadoch, MD principal investigator
Clinique Ovo
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 Contraceptives, Oral and Contraceptive, Vaginal ring in people with Infertility, run by Clinique Ovo at 1 site in Canada.
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 6 inclusion and 27 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 27 Jul 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 Canada. 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 was stopped early (reason given: Difficulty to recruit patient due to lack of eligible patient). Results are not available in the source record.
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?
The level of satisfaction in patients in relation to contraceptive medication (time frame: From date of the beginning of the In Vitro Fertilization cycle until the end of the cycle, assesses up to 65 days.). The study lists 5 primary outcomes in all. 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 NCT01638767, which also lists 3 linked publications.
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 27 Jul 2015.