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

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. Identifier: NCT01298128
Recruitment Status : Terminated
First Posted : February 17, 2011
Results First Posted : July 17, 2012
Last Update Posted : October 5, 2012
Information provided by (Responsible Party):
Kimberly Liu, University of Toronto

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Infertility
In-vitro Fertilization
Interventions: Drug: NuvaRing
Drug: marvelon

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
NuvaRing NuvaRing for IVF pre-treatment
Combined Oral Contraceptive Pill OCP for IVF pre-treatment

Participant Flow:   Overall Study
    NuvaRing   Combined Oral Contraceptive Pill
STARTED   35   35 
COMPLETED   26   27 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
NuvaRing NuvaRing for IVF pre-treatment
Combined Oral Contraceptive Pill OCP for IVF pre-treatment
Total Total of all reporting groups

Baseline Measures
   NuvaRing   Combined Oral Contraceptive Pill   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   35   70 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   35   35   70 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 33.6  (2)   32.8  (2)   33  (2) 
[Units: Participants]
Female   35   35   70 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
Canada   35   35   70 

  Outcome Measures

1.  Primary:   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 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
early termination due to poor recruitment

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Kimberly Liu
Organization: Mount Sinai Hospital
phone: 416-586-5367

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Kimberly Liu, University of Toronto 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