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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01298128
• Other study ID #: CFRH- 001
• 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

• In-vitro Fertilization
• Infertility

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