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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01298128
Other study ID # CFRH- 001
Secondary ID
Status Terminated
Phase N/A
First received February 15, 2011
Last updated October 1, 2012
Start date February 2006
Est. completion date December 2010

Study information

Verified date October 2012
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority Canada: Mount Sinai Hospital, Research Ethics Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 70
Est. completion date December 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 38 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
NuvaRing
NuvaRIng 21 days for IVF pre-treatment.
marvelon
marvelon 21 daily

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Toronto

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description) abnormal bleeding, intermittent bleeding, headache, breast discomfort, bloating, mood swings, nausea, vaginal discharge, vomitting, weight gain patients were followed for the duration of an in-vitro fertilization cycle- 2 months No
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