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

• Sponsor: University of Toronto (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01298128
• Collaborator: (none)
• Enrollment: 70
• Arms: 2
• Duration (Months): 58

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility; In-vitro Fertilization	Drug: NuvaRing; Drug: marvelon	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial of NuvaRing® Versus Combined Oral Contraceptive Pills for Pre-treatment in In-Vitro Fertilization (IVF) Cycles
• Study Start Date: Feb 1, 2006
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NuvaRing NuvaRing for IVF pre-treatment	Drug: NuvaRing; NuvaRIng 21 days for IVF pre-treatment.
Active Comparator: Combined oral contraceptive pill OCP for IVF pre-treatment	Drug: marvelon; marvelon 21 daily

Outcome Measures

Primary Outcome Measures

1. Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description) [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 38 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Toronto

Investigators

• Principal Investigator: Kimberly E Liu, MD, Mount Sinai Hospital, Toronto ON

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kimberly Liu, Physician, University of Toronto
• ClinicalTrials.gov Identifier: NCT01298128
• Other Study ID Numbers: CFRH- 001
• First Posted: Feb 17, 2011
• Last Update Posted: Oct 5, 2012
• Last Verified: Oct 1, 2012

• Additional relevant MeSH terms: Infertility; NuvaRing; Desogestrel

Study Results

Participant Flow

Arm/Group Title	NuvaRing	Combined Oral Contraceptive Pill
Arm/Group Description	NuvaRing for IVF pre-treatment	OCP for IVF pre-treatment
Period Title: Overall Study
STARTED	35	35
COMPLETED	26	27
NOT COMPLETED	9	8

Baseline Characteristics

Arm/Group Title	NuvaRing	Combined Oral Contraceptive Pill	Total
Arm/Group Description	NuvaRing for IVF pre-treatment	OCP for IVF pre-treatment	Total of all reporting groups
Overall Participants	35	35	70
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	35 100%	35 100%	70 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.6 (2)	32.8 (2)	33 (2)
Sex: Female, Male (Count of Participants)
Female	35 100%	35 100%	70 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Canada	35 100%	35 100%	70 100%

Outcome Measures

1. Primary Outcome

Title	Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description)
Description	abnormal bleeding, intermittent bleeding, headache, breast discomfort, bloating, mood swings, nausea, vaginal discharge, vomitting, weight gain
Time Frame	patients were followed for the duration of an in-vitro fertilization cycle- 2 months

Outcome Measure Data

Analysis Population Description

70 patients were recruited and randomized. 53 patients completed the study. 11 patients did not then undergo an ivf cycle after recruitment. 6 patients withdrew from the study after recruitment.

Arm/Group Title	NuvaRing	Combined Oral Contraceptive Pill
Arm/Group Description	NuvaRing for IVF pre-treatment	OCP for IVF pre-treatment
Measure Participants	26	27
Number [participants]	3 8.6%	4 11.4%

Adverse Events

Arm/Group Title	NuvaRing		Combined Oral Contraceptive Pill
Arm/Group Description	NuvaRing for IVF pre-treatment		OCP for IVF pre-treatment
All Cause Mortality
	NuvaRing		Combined Oral Contraceptive Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	NuvaRing		Combined Oral Contraceptive Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	NuvaRing		Combined Oral Contraceptive Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)

Limitations/Caveats

early termination due to poor recruitment

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.