NuvaRing Versus Marvelon in the Coordination of In Vitro Fertilization Cycles

Infertility Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01638767
• Other study ID #: OVO-10-03
• Status: Terminated
• Phase: Phase 4
• First received: July 6, 2012
• Last updated: July 24, 2015
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: July 2015
• Source: OVO R & D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Infertility

Intervention

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.
• 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

Locations

Country	Name	City	State
Canada	Clinique Ovo	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
OVO R & D	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Novák 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. — View Citation

Roumen 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. — View Citation

Timmer CJ, Mulders TM. Pharmacokinetics of etonogestrel and ethinylestradiol released from a combined contraceptive vaginal ring. Clin Pharmacokinet. 2000 Sep;39(3):233-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of satisfaction in patients in relation to contraceptive medication		From date of the beginning of the In Vitro Fertilization cycle until the end of the cycle, assesses up to 65 days.	No
Primary	The level of stress experienced by patients in relation to contraceptive medication		From date of the beginning of the In Vitro Fertilization cycle until the end of the cycle, assesses up to 65 days.	No
Primary	Patient's adherence to the treatment		From date of the beginning of the In Vitro Fertilization cycle until the end of the cycle, assesses up to 65 days.	No
Primary	The number of patients who had bleeding during their contraceptive treatment		From date of the beginning of the In Vitro Fertilization cycle until the end of the cycle, assesses up to 65 days.	Yes
Primary	The level of satisfaction among administrative nurses in regards to planning the cycle.		From date of the beginning of the In Vitro Fertilization cycle until the end of the cycle, assesses up to 65 days.	No
Secondary	The number of follicles at the last sonogram before the Human chorionic gonadotropin (hCG) injection		At time of the last sonogram before the Human chorionicgonadotropin (hCG) injection, approximately 20 days	No
Secondary	The presence of cysts (diameter = 15 mm)		From date of the beginning of the In Vitro Fertilization cycle until the end of the cycle, assesses up to 65 days.	Yes
Secondary	The number of mature ova recovered		At the time of ova retrieval, approximately 20 days	No
Secondary	The number of usable embryos		From the time of ova retrieval until the time of embryo transfer, up to 5 days.	No
Secondary	The pregnancy rates		At the time of the pregnancy test, approximately 20 days	No