Trial Outcomes & Findings for Maximal Stimulation and Delayed Fertilization for Diminished Ovarian Reserve: a Randomized Pilot Study (NCT NCT01921166)
NCT ID: NCT01921166
Last Updated: 2024-08-02
Results Overview
Number of oocytes retrieved
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
23 participants
Primary outcome timeframe
up to 24 months
Results posted on
2024-08-02
Participant Flow
Participant milestones
| Measure |
Clomiphene Plus Gonadotropins
clomiphene plus gonadotropins
clomiphene plus gonadotropins: clomiphene plus gonadotropin ovulation induction
|
Leuprolide Flare
Leuprolide flare
Leuprolide flare: Leuprolide flare ovulation induction
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
15
|
|
Overall Study
COMPLETED
|
8
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Maximal Stimulation and Delayed Fertilization for Diminished Ovarian Reserve: a Randomized Pilot Study
Baseline characteristics by cohort
| Measure |
Leuprolide Flare
n=15 Participants
Leuprolide flare
Leuprolide flare: Leuprolide flare ovulation induction
|
Total
n=23 Participants
Total of all reporting groups
|
Clomiphene Plus Gonadotropins
n=8 Participants
clomiphene plus gonadotropins
clomiphene plus gonadotropins: clomiphene plus gonadotropin ovulation induction
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 24 monthsNumber of oocytes retrieved
Outcome measures
| Measure |
Clomiphene Plus Gonadotropins
n=19 oocytes
clomiphene plus gonadotropins
clomiphene plus gonadotropins: clomiphene plus gonadotropin ovulation induction
|
Leuprolide Flare
n=47 oocytes
Leuprolide flare
Leuprolide flare: Leuprolide flare ovulation induction
|
|---|---|---|
|
Oocytes
|
19 oocytes
|
47 oocytes
|
SECONDARY outcome
Timeframe: up to 24 monthsOutcome measures
| Measure |
Clomiphene Plus Gonadotropins
n=8 Participants
clomiphene plus gonadotropins
clomiphene plus gonadotropins: clomiphene plus gonadotropin ovulation induction
|
Leuprolide Flare
n=15 Participants
Leuprolide flare
Leuprolide flare: Leuprolide flare ovulation induction
|
|---|---|---|
|
Number of Oocytes Vitrified
|
19 oocytes
|
47 oocytes
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 24 monthsper ovarian stimulation treatment protocol
Outcome measures
Outcome data not reported
Adverse Events
Clomiphene Plus Gonadotropins
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Leuprolide Flare
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
Bradley Hurst, M.D., Director of Assisted Reproduction
AtriumHealth
Phone: 704-355-3149
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place