NuvaRing Versus Marvelon in the Coordination of In Vitro Fertilization Cycles

NCT01638767 | Terminated Phase 4

• 1 other identifier: OVO-10-03
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility

Keywords

In Vitro Fertilization long protocol; NuvaRing; Marvelon; In vitro fertilization

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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.

Secondary Outcomes (5)

• 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

• 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.

• The number of mature ova recovered

  At the time of ova retrieval, approximately 20 days

• The number of usable embryos

  From the time of ova retrieval until the time of embryo transfer, up to 5 days.

• The pregnancy rates

  At the time of the pregnancy test, approximately 20 days

Study Arms (2)

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.

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.

Drug: Contraceptives, Oral

Interventions

Contraceptives, Oral DRUG

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.

Also known as: Marvelon

Marvelon

Contraceptive, Vaginal ring DRUG

etogestrel/ ethinyl estradiol slow release vaginal ring (11.4 mg/2.6 mg) to deliver 120 mcg etonogestrel/15 mcg ethinyl estradiol per day

Also known as: NuvaRing

NuvaRing

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Ovo: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Location

Related Publications (3)

• 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.

  PMID: 11020137 BACKGROUND

• 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. doi: 10.1093/humrep/16.3.469.

  PMID: 11228213 BACKGROUND

• Novak 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.

  PMID: 12618252 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Contraceptives, Oral; Desogestrel; Contraceptive Agents; Contraceptive Devices, Female; NuvaRing

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Contraceptive Devices; Equipment and Supplies

Study Officials

• Jacques Kadoch, MD

  Clinique Ovo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 12, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 27, 2015

Record last verified: 2015-07

Locations

CA (1)