Infertility Clinical Trial
Official title:
A Randomized Controlled Trial of NuvaRing® Versus Combined Oral Contraceptive Pills for Pre-treatment in In-Vitro Fertilization (IVF) Cycles
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Toronto |
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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