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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
  Purpose

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.


Condition Intervention
Infertility
In-vitro Fertilization
Drug: NuvaRing
Drug: marvelon

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of NuvaRing® Versus Combined Oral Contraceptive Pills for Pre-treatment in In-Vitro Fertilization (IVF) Cycles

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • 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


Enrollment: 70
Study Start Date: February 2006
Study Completion Date: December 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NuvaRing
NuvaRing for IVF pre-treatment
Drug: NuvaRing
NuvaRIng 21 days for IVF pre-treatment.
Active Comparator: Combined oral contraceptive pill
OCP for IVF pre-treatment
Drug: marvelon
marvelon 21 daily
Other Name: Marvelon

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298128

Sponsors and Collaborators
University of Toronto
Investigators
Principal Investigator: Kimberly E Liu, MD Mount Sinai Hospital, Toronto ON
  More Information

No publications provided

Responsible Party: Kimberly Liu, Physician, University of Toronto
ClinicalTrials.gov Identifier: NCT01298128     History of Changes
Other Study ID Numbers: CFRH- 001
Study First Received: February 15, 2011
Results First Received: August 17, 2011
Last Updated: October 1, 2012
Health Authority: Canada: Mount Sinai Hospital, Research Ethics Board

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Contraceptive Agents, Female
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014