drugset / Trial / NCT01638767

NuvaRing Versus Marvelon in the Coordination of In Vitro Fertilization Cycles

NCT01638767

Phase 4 Terminated 7 enrolled Clinique Ovo Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupOpen-label

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.

Timeline

Start
2012-07
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Desogestrel Small molecule 0.15 mg Oral
Subject Etonogestrel Unknown 0.12 mg Other
Comparator ethinyl estradiol Small molecule 0.015 mg Oral
Comparator ethinyl estradiol Small molecule 0.03 mg Oral

Indications