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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NuvaRing | Experimental | NuvaRing for IVF pre-treatment |
|
| Combined oral contraceptive pill | Active Comparator | OCP for IVF pre-treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NuvaRing | Drug | NuvaRIng 21 days for IVF pre-treatment. |
| |
| marvelon |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly E Liu, MD | Mount Sinai Hospital, Toronto ON | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21880278 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NuvaRing | NuvaRing for IVF pre-treatment |
| FG001 | Combined Oral Contraceptive Pill | OCP for IVF pre-treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NuvaRing | NuvaRing for IVF pre-treatment |
| BG001 | Combined Oral Contraceptive Pill | OCP for IVF pre-treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Number | participants | patients were followed for the duration of an in-vitro fertilization cycle- 2 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NuvaRing | NuvaRing for IVF pre-treatment |
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early termination due to poor recruitment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kimberly Liu | Mount Sinai Hospital | 416-586-5367 | kliu@mtsinai.on.ca |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C516519 | NuvaRing |
| D017135 | Desogestrel |
| ID | Term |
|---|---|
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 |
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| Drug |
marvelon 21 daily |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
OCP for IVF pre-treatment |
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Combined Oral Contraceptive Pill | OCP for IVF pre-treatment | 0 | 27 | 0 | 26 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |