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

Primary Purpose

Infertility, In-vitro Fertilization

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NuvaRing
marvelon
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    NuvaRing

    Combined oral contraceptive pill

    Arm Description

    NuvaRing for IVF pre-treatment

    OCP for IVF pre-treatment

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 15, 2011
    Last Updated
    October 1, 2012
    Sponsor
    University of Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01298128
    Brief Title
    NuvaRing vs. Oral Contraceptive Pills (OCP) for In-Vitro Fertilization (IVF) Pre-treatment
    Official Title
    A Randomized Controlled Trial of NuvaRing® Versus Combined Oral Contraceptive Pills for Pre-treatment in In-Vitro Fertilization (IVF) Cycles
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Terminated
    Study Start Date
    February 2006 (undefined)
    Primary Completion Date
    March 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Toronto

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility, In-vitro Fertilization

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    NuvaRing
    Arm Type
    Experimental
    Arm Description
    NuvaRing for IVF pre-treatment
    Arm Title
    Combined oral contraceptive pill
    Arm Type
    Active Comparator
    Arm Description
    OCP for IVF pre-treatment
    Intervention Type
    Drug
    Intervention Name(s)
    NuvaRing
    Intervention Description
    NuvaRIng 21 days for IVF pre-treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    marvelon
    Intervention Description
    marvelon 21 daily
    Primary Outcome Measure Information:
    Title
    Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description)
    Description
    abnormal bleeding, intermittent bleeding, headache, breast discomfort, bloating, mood swings, nausea, vaginal discharge, vomitting, weight gain
    Time Frame
    patients were followed for the duration of an in-vitro fertilization cycle- 2 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    38 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: Any contraindication to COC use. Hypersensitivity to Nuva ring or any of its components. Language barrier to consent.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kimberly E Liu, MD
    Organizational Affiliation
    Mount Sinai Hospital, Toronto ON
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21880278
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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