NuvaRing vs. Oral Contraceptive Pills (OCP) for In-Vitro Fertilization (IVF) Pre-treatment

NCT01298128 | Terminated Results

• 1 other identifier: CFRH- 001
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

The newly designed contraceptive ring, Nuvaring has a lower total steroid dose, and medications are delivered locally. It has been proven to be as safe and effective as the combined OCP in ovarian suppression and preventing ovulation with fewer side effects due to minimal systemic absorption. Following a single vaginal insertion, steroid concentrations remain stable for up to 4 weeks. It is hypothesized that Nuvaring may, therefore lead to better compliance, tolerability and acceptance by patients requiring ovarian suppression prior to COH for IVF.

Conditions

Infertility; In-vitro Fertilization

Outcome Measures

Primary Outcomes (1)

• Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description)

  abnormal bleeding, intermittent bleeding, headache, breast discomfort, bloating, mood swings, nausea, vaginal discharge, vomitting, weight gain

  patients were followed for the duration of an in-vitro fertilization cycle- 2 months

Study Arms (2)

NuvaRing

EXPERIMENTAL

NuvaRing for IVF pre-treatment

Drug: NuvaRing

Combined oral contraceptive pill

ACTIVE COMPARATOR

OCP for IVF pre-treatment

Drug: marvelon

Interventions

NuvaRing DRUG

NuvaRIng 21 days for IVF pre-treatment.

NuvaRing

marvelon DRUG

marvelon 21 daily

Combined oral contraceptive pill

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients less than 38 years of age.
• Healthy women starting their first IVF/ICSI cycle.
• No contraindication to Combined Oral Contraceptive (COC) use. Appendix 1
• Consent to randomization.

You may not qualify if:

• Any contraindication to COC use.
• Hypersensitivity to Nuva ring or any of its components.
• Language barrier to consent.

Sponsors & Collaborators

• University of Toronto: lead

Related Publications (1)

• Liu KE, Alhajri M, Greenblatt E. A randomized controlled trial of NuvaRing versus combined oral contraceptive pills for pretreatment in in vitro fertilization cycles. Fertil Steril. 2011 Sep;96(3):605-8. doi: 10.1016/j.fertnstert.2011.06.073.

  PMID: 21880278 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

NuvaRing; Desogestrel

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

early termination due to poor recruitment

Results Point of Contact

• Title: Dr. Kimberly Liu
• Organization: Mount Sinai Hospital

kliu@mtsinai.on.ca

416-586-5367

Study Officials

• Kimberly E Liu, MD

  Mount Sinai Hospital, Toronto ON

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: February 17, 2011
• Study Start: February 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 5, 2012
• Results First Posted: July 17, 2012

Record last verified: 2012-10