Trial Outcomes & Findings for NuvaRing vs. Oral Contraceptive Pills (OCP) for In-Vitro Fertilization (IVF) Pre-treatment (NCT NCT01298128)

Last Updated: 2012-10-05

Results Overview

abnormal bleeding, intermittent bleeding, headache, breast discomfort, bloating, mood swings, nausea, vaginal discharge, vomitting, weight gain

Recruitment status

TERMINATED

Study phase

Target enrollment

70 participants

Primary outcome timeframe

patients were followed for the duration of an in-vitro fertilization cycle- 2 months

Results posted on

2012-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	NuvaRing NuvaRing for IVF pre-treatment	Combined Oral Contraceptive Pill OCP for IVF pre-treatment
Overall Study STARTED	35	35
Overall Study COMPLETED	26	27
Overall Study NOT COMPLETED	9	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NuvaRing n=35 Participants NuvaRing for IVF pre-treatment	Combined Oral Contraceptive Pill n=35 Participants OCP for IVF pre-treatment	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	33.6 years STANDARD_DEVIATION 2 • n=5 Participants	32.8 years STANDARD_DEVIATION 2 • n=7 Participants	33 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: patients were followed for the duration of an in-vitro fertilization cycle- 2 months

Population: 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.

abnormal bleeding, intermittent bleeding, headache, breast discomfort, bloating, mood swings, nausea, vaginal discharge, vomitting, weight gain

Outcome measures

Outcome measures
Measure	NuvaRing n=26 Participants NuvaRing for IVF pre-treatment	Combined Oral Contraceptive Pill n=27 Participants OCP for IVF pre-treatment
Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description)	3 participants	4 participants

Adverse Events

NuvaRing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Combined Oral Contraceptive Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kimberly Liu

Mount Sinai Hospital

Phone: 416-586-5367

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place