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
Results First Received: August 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Infertility
In-vitro Fertilization
Interventions: Drug: NuvaRing
Drug: marvelon

  Participant Flow
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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
  Description
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  
NOT COMPLETED     9     8  



  Baseline Characteristics
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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
  Description
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  
Number of Participants  
[units: participants]
  35     35     70  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     35     35     70  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  33.6  ± 2     32.8  ± 2     33  ± 2  
Gender  
[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
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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
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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
e-mail: kliu@mtsinai.on.ca


No publications provided


Responsible Party: Kimberly Liu, 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