Infertility, In-vitro Fertilization
Conditions
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.
Sponsors
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NuvaRing NuvaRing for IVF pre-treatment | 35 |
| Combined Oral Contraceptive Pill OCP for IVF pre-treatment | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Combined Oral Contraceptive Pill | NuvaRing | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 35 Participants | 70 Participants |
| Age Continuous | 32.8 years STANDARD_DEVIATION 2 | 33.6 years STANDARD_DEVIATION 2 | 33 years STANDARD_DEVIATION 2 |
| Region of Enrollment Canada | 35 participants | 35 participants | 70 participants |
| Sex: Female, Male Female | 35 Participants | 35 Participants | 70 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 27 |
Outcome results
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
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NuvaRing | Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description) | 3 participants |
| Combined Oral Contraceptive Pill | Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description) | 4 participants |