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

NCT ID: NCT01298128

Last Updated: 2012-10-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility In-vitro Fertilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NuvaRing

NuvaRing for IVF pre-treatment

Group Type EXPERIMENTAL

NuvaRing

Intervention Type DRUG

NuvaRIng 21 days for IVF pre-treatment.

Combined oral contraceptive pill

OCP for IVF pre-treatment

Group Type ACTIVE_COMPARATOR

marvelon

Intervention Type DRUG

marvelon 21 daily

Interventions

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NuvaRing

NuvaRIng 21 days for IVF pre-treatment.

Intervention Type DRUG

marvelon

marvelon 21 daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Kimberly Liu

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kimberly E Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Hospital, Toronto ON

References

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Liu KE, Alhajri M, Greenblatt E. A randomized controlled trial of NuvaRing versus combined oral contraceptive pills for pretreatment in in vitro fertilization cycles. Fertil Steril. 2011 Sep;96(3):605-8. doi: 10.1016/j.fertnstert.2011.06.073.

Reference Type DERIVED
PMID: 21880278 (View on PubMed)

Other Identifiers

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CFRH- 001

Identifier Type: -

Identifier Source: org_study_id