A Randomized Controlled Trial of NuvaRing® Versus Combined Oral Contraceptive Pills for Pre-treatment in In-Vitro Fertilization (IVF) Cycles
Overview
- Phase
- Not Applicable
- Intervention
- marvelon
- Conditions
- Infertility
- Sponsor
- University of Toronto
- Enrollment
- 70
- Primary Endpoint
- Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description)
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief 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.
Investigators
Kimberly Liu
Physician
University of Toronto
Eligibility 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.
Arms & Interventions
Combined oral contraceptive pill
OCP for IVF pre-treatment
Intervention: marvelon
NuvaRing
NuvaRing for IVF pre-treatment
Intervention: NuvaRing
Outcomes
Primary Outcomes
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