NuvaRing Versus Marvelon in the Coordination of In Vitro Fertilization Cycles
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|ClinicalTrials.gov Identifier: NCT01638767|
Recruitment Status : Terminated (Difficulty to recruit patient due to lack of eligible patient)
First Posted : July 12, 2012
Last Update Posted : July 27, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: Contraceptives, Oral Drug: Contraceptive, Vaginal ring||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
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.
Drug: Contraceptive, Vaginal ring
etogestrel/ ethinyl estradiol slow release vaginal ring (11.4 mg/2.6 mg) to deliver 120 mcg etonogestrel/15 mcg ethinyl estradiol per day
Other Name: NuvaRing
Active Comparator: Marvelon
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.
Drug: Contraceptives, Oral
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.
Other Name: Marvelon
- 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. ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638767
|Montreal, Quebec, Canada, H4P 2S4|
|Principal Investigator:||Jacques Kadoch, MD||OVO R & D|