NuvaRing Versus Marvelon in the Coordination of In Vitro Fertilization Cycles

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinique Ovo; OVO R & D
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Contraceptive Agents; Contraceptives, Oral; Desogestrel; Ethinyl Estradiol; NuvaRing

Criteria

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