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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Kimberly Liu, University of Toronto
ClinicalTrials.gov Identifier:
NCT01298128
First received: February 15, 2011
Last updated: October 1, 2012
Last verified: October 2012

February 15, 2011
October 1, 2012
February 2006
March 2010   (final data collection date for primary outcome measure)
Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description) [ Time Frame: patients were followed for the duration of an in-vitro fertilization cycle- 2 months ] [ Designated as safety issue: No ]
abnormal bleeding, intermittent bleeding, headache, breast discomfort, bloating, mood swings, nausea, vaginal discharge, vomitting, weight gain
Side effects [ Designated as safety issue: Yes ]
Side effects of OCP
Complete list of historical versions of study NCT01298128 on ClinicalTrials.gov Archive Site
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NuvaRing vs. Oral Contraceptive Pills (OCP) for In-Vitro Fertilization (IVF) Pre-treatment
A Randomized Controlled Trial of NuvaRing® Versus Combined Oral Contraceptive Pills for Pre-treatment in In-Vitro Fertilization (IVF) Cycles

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.

Not Provided
Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Infertility
  • In-vitro Fertilization
  • Drug: NuvaRing
    NuvaRIng 21 days for IVF pre-treatment.
  • Drug: marvelon
    marvelon 21 daily
    Other Name: Marvelon
  • Experimental: NuvaRing
    NuvaRing for IVF pre-treatment
    Intervention: Drug: NuvaRing
  • Active Comparator: Combined oral contraceptive pill
    OCP for IVF pre-treatment
    Intervention: Drug: marvelon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
70
December 2010
March 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years to 38 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01298128
CFRH- 001
No
Kimberly Liu, University of Toronto
University of Toronto
Not Provided
Principal Investigator: Kimberly E Liu, MD Mount Sinai Hospital, Toronto ON
University of Toronto
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP