TriangleNCT01185782 · OUTCOME
Single Follicle Maturation Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percent single follicle maturation
- Interval / dispersion
- Not reported
- Time frame
- Start of treatment period until Day 1 of post-treatment assessment period
What was measured
Single follicle maturation was defined as the presence of the dominant follicle with a mean diameter of 18 mm or greater without concurrent presence of other follicles of 14 mm or larger in diameter.
Analysis population: FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.
Groups in this outcome
SJ-0021
SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
u-hFSH
Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
| Group | Source count |
|---|---|
| SJ-0021 | 129 |
| u-hFSH | 132 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SJ-0021 | 33.3 | Not reported | Not reported | Not reported | Not reported |
| u-hFSH | 43.2 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.102
- statistical Method
- Chi-squared
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.102
- statistical Method
- Chi-squared
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 33.3
- group Id
- OG001
- value
- 43.2
- denoms
- counts
- group Id
- OG000
- value
- 129
- group Id
- OG001
- value
- 132
- units
- Participants
- description
- Single follicle maturation was defined as the presence of the dominant follicle with a mean diameter of 18 mm or greater without concurrent presence of other follicles of 14 mm or larger in diameter.
- groups
- description
- SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
- id
- OG000
- title
- SJ-0021
- description
- Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
- id
- OG001
- title
- u-hFSH
- param Type
- NUMBER
- population Description
- FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.
- reporting Status
- POSTED
- time Frame
- Start of treatment period until Day 1 of post-treatment assessment period
- title
- Single Follicle Maturation Rate
- type
- SECONDARY
- unit Of Measure
- percent single follicle maturation
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice