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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01298128
First Posted: February 17, 2011
Last Update Posted: October 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kimberly Liu, University of Toronto
  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
Intervention Model: Parallel Assignment
Masking: None (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

Further study details as provided by Kimberly Liu, 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 ]
    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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298128


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kimberly Liu, Physician, University of Toronto
ClinicalTrials.gov Identifier: NCT01298128     History of Changes
Other Study ID Numbers: CFRH- 001
First Submitted: February 15, 2011
First Posted: February 17, 2011
Results First Submitted: August 17, 2011
Results First Posted: July 17, 2012
Last Update Posted: October 5, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Contraceptive Agents
Desogestrel
Contraceptives, Oral
Contraceptives, Oral, Combined
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Progestins


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