Trial Outcomes & Findings for Delayed Start to Ovarian Stimulation (NCT NCT01614067)
NCT ID: NCT01614067
Last Updated: 2021-06-15
Results Overview
Developmental competence (fertilization of oocytes) through standard in vitro fertilization (estimated time frame to be between 8-24 hours following IVF). This percentage will be calculated as the number of fertilized eggs ( 2PN stage) per total number of eggs collected from the egg retrieval.
TERMINATED
PHASE4
30 participants
8 to 24 hours after in vitro fertilization, oocytes will be checked for fertilization
2021-06-15
Participant Flow
With a goal of enrolling a total of 114 subjects, 330 potential candidates were screened for eligibility. 300 candidates were either not eligible or declined participation. 30 subjects were found eligible to participate and enrolled in the study.
Participant milestones
| Measure |
Delayed Start
Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.
Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist
|
Conventional Start
Ovarian stimulation with standard antagonist protocols (no delay).
Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
15
|
15
|
Reasons for withdrawal
| Measure |
Delayed Start
Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.
Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist
|
Conventional Start
Ovarian stimulation with standard antagonist protocols (no delay).
Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist
|
|---|---|---|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Physician Decision
|
6
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Study terminated early by sponsor and was unable to collect data
|
8
|
9
|
Baseline Characteristics
Delayed Start to Ovarian Stimulation
Baseline characteristics by cohort
| Measure |
Delayed Start
n=15 Participants
Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.
Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist
|
Conventional Start
n=15 Participants
Ovarian stimulation with standard antagonist protocols (no delay).
Ganirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist
|
Total
n=30 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
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 to 24 hours after in vitro fertilization, oocytes will be checked for fertilizationPopulation: The study was terminated early and no data were collected for this outcome measure
Developmental competence (fertilization of oocytes) through standard in vitro fertilization (estimated time frame to be between 8-24 hours following IVF). This percentage will be calculated as the number of fertilized eggs ( 2PN stage) per total number of eggs collected from the egg retrieval.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: up to 1 hour after oocytes retrievedPopulation: The study was terminated early and no data were collected for this outcome measure
The egg retrieval procedure will be performed 36 hours after the ovulation trigger. The procedure is estimated to take up to 1 hour at study visit as part of routine care. The number of retrieved eggs will be counted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One hour on day 2 or 3 (following IVF procedure)Population: The study was terminated early and no data were collected for this outcome measure
Embryo quality will be assessed by the embryologist on days 2 or 3 (Cleavage stage) following IVF using standard embryo grading criteria. Embryos grading is based on three criteria: the number of blastomere cells present in the embryo, the degree of observed cell fragmentation and the degree of observed symmetry of the cells.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 to 3 weeks following embryo transferPopulation: The study was terminated early and no data were collected for this outcome measure
Beta HCG levels will be assessed at 2 weeks and 3 weeks after embryo transfer. A positive pregnancy is defined as two positive beta HCG levels (a value \> 5 mIU/ml ) observed over the time frame.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: average of 1 to 2 hours on the Day of RetrievalPopulation: The study was terminated early and no data were collected for this outcome measure
Quality of oocytes will be assessed for developmental stages (Germinal Vesicles, Meiosis I, or Meiosis II)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 1 hour (during the Transvaginal Ultrasound before Retrieval of Oocytes)Population: The study was terminated early and no data were collected for this outcome measure
Maturation of follicles will be assessed by measuring the size of follicles (mature \> 13mm) prior to (or at the time of) oocytes retrieval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 1 hours after oocyte retrievalPopulation: The study was terminated early and no data were collected for this outcome measure
The number of oocytes recovered at the time of oocyte retrieval following ovarian stimulation.
Outcome measures
Outcome data not reported
Adverse Events
Delayed Start
Conventional Start
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mitchell Rosen, MD
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place