Trial Outcomes & Findings for Double Pick up in Poor Prognosis Women (NCT NCT03846544)
NCT ID: NCT03846544
Last Updated: 2024-05-21
Results Overview
number of mature (or metaphase II, MII) oocytes retrieved during oocyte retrieval
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
48 participants
Primary outcome timeframe
1 month
Results posted on
2024-05-21
Participant Flow
Participant milestones
| Measure |
Control Group
conventional stimulation group
|
Double Pick up Group
CFA-double pick up: In the study group, 225 IU of rFSH will continue after the first oocyte retrieval (OR). Antagonist administration will be initiated when at least one follicle measuring ≥14 mm will be present in the ultrasound. If one or more follicles ≥17 mm are observed, patients will undergo a second triggering with hCG 5000 IU and a second OR will be performed. In case of patients with no follicular development following 10 additional days of rFSH post-OR
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Double Pick up in Poor Prognosis Women
Baseline characteristics by cohort
| Measure |
Control Group
n=24 Participants
A single injection of 150mcg of corifollitropin alfa was administrated at day 2/3 of the cycle, followed by 225IU of recombinant FSH (rFSH) in a fixed antagonist protocol. Group A (control group) underwent conventional triggering with hCG 5000 IU and a single oocyte retrieval (OR)
|
Double Pick up Group
n=24 Participants
A single injection of 150mcg of corifollitropin alfa was administrated at day 2/3 of the cycle, followed by 225IU of recombinant FSH (rFSH) in a fixed antagonist protocol. Group B (study group) underwent triggering with GnRHagonist. 225 IU of rFSH was continued after the first oocyte retrieval (OR). Antagonist administration was initiated when at least one follicle measuring ≥14 mm was present on the ultrasound. If one or more follicles ≥17 mm were observed, patients underwent a second triggering with hCG 5000 IU and a second OR was performed. In case of patients with no follicular development following 13 additional days of rFSH.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
36.3 years
STANDARD_DEVIATION 3.6 • n=99 Participants
|
35.6 years
STANDARD_DEVIATION 2.9 • n=107 Participants
|
36 years
STANDARD_DEVIATION 3.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Body Mass index (BMI)
|
24.3 kg/m^2
STANDARD_DEVIATION 3.7 • n=99 Participants
|
24.5 kg/m^2
STANDARD_DEVIATION 5.0 • n=107 Participants
|
24.4 kg/m^2
STANDARD_DEVIATION 4.3 • n=206 Participants
|
|
Anti-Müllerian hormone (AMH)
|
0.5 ng/ml
STANDARD_DEVIATION 0.2 • n=99 Participants
|
0.6 ng/ml
STANDARD_DEVIATION 0.3 • n=107 Participants
|
0.55 ng/ml
STANDARD_DEVIATION 0.27 • n=206 Participants
|
|
antral follicle count (AFC)
|
6.6 number of follicles
STANDARD_DEVIATION 3.3 • n=99 Participants
|
5.7 number of follicles
STANDARD_DEVIATION 2.8 • n=107 Participants
|
6.1 number of follicles
STANDARD_DEVIATION 3.1 • n=206 Participants
|
|
basal FSH
|
9.7 IU/L
STANDARD_DEVIATION 3.6 • n=99 Participants
|
9.8 IU/L
STANDARD_DEVIATION 3.4 • n=107 Participants
|
9.8 IU/L
STANDARD_DEVIATION 3.4 • n=206 Participants
|
|
infertility duration
|
2.4 years
STANDARD_DEVIATION 1.8 • n=99 Participants
|
3.7 years
STANDARD_DEVIATION 7.0 • n=107 Participants
|
3.1 years
STANDARD_DEVIATION 5.1 • n=206 Participants
|
PRIMARY outcome
Timeframe: 1 monthnumber of mature (or metaphase II, MII) oocytes retrieved during oocyte retrieval
Outcome measures
| Measure |
Control Group
n=23 Participants
A single injection of 150mcg of corifollitropin alfa was administrated at day 2/3 of the cycle, followed by 225IU of recombinant FSH (rFSH) in a fixed antagonist protocol. Group A (control group) underwent conventional triggering with hCG 5000 IU and a single oocyte retrieval (OR)
|
Double Pick up Group
n=23 Participants
A single injection of 150mcg of corifollitropin alfa was administrated at day 2/3 of the cycle, followed by 225IU of recombinant FSH (rFSH) in a fixed antagonist protocol. Group B (study group) underwent triggering with GnRHagonist. 225 IU of rFSH was continued after the first oocyte retrieval (OR). Antagonist administration was initiated when at least one follicle measuring ≥14 mm was present on the ultrasound. If one or more follicles ≥17 mm were observed, patients underwent a second triggering with hCG 5000 IU and a second OR was performed. In case of patients with no follicular development following 13 additional days of rFSH.
|
|---|---|---|
|
Number of MII Oocytes Retrieved Between the Two Arms
|
4.1 number of oocytes
Standard Deviation 2.4
|
3.0 number of oocytes
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 1 monthnumber of follicles ≥11m on the day of final oocyte maturation trigger
Outcome measures
| Measure |
Control Group
n=23 Participants
A single injection of 150mcg of corifollitropin alfa was administrated at day 2/3 of the cycle, followed by 225IU of recombinant FSH (rFSH) in a fixed antagonist protocol. Group A (control group) underwent conventional triggering with hCG 5000 IU and a single oocyte retrieval (OR)
|
Double Pick up Group
n=23 Participants
A single injection of 150mcg of corifollitropin alfa was administrated at day 2/3 of the cycle, followed by 225IU of recombinant FSH (rFSH) in a fixed antagonist protocol. Group B (study group) underwent triggering with GnRHagonist. 225 IU of rFSH was continued after the first oocyte retrieval (OR). Antagonist administration was initiated when at least one follicle measuring ≥14 mm was present on the ultrasound. If one or more follicles ≥17 mm were observed, patients underwent a second triggering with hCG 5000 IU and a second OR was performed. In case of patients with no follicular development following 13 additional days of rFSH.
|
|---|---|---|
|
Number of Preovulatory Follicles
|
5.4 number of follicles
Standard Deviation 2.2
|
5.0 number of follicles
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 1 monthnumber of COCs retrieved at oocyte retrieval
Outcome measures
| Measure |
Control Group
n=23 Participants
A single injection of 150mcg of corifollitropin alfa was administrated at day 2/3 of the cycle, followed by 225IU of recombinant FSH (rFSH) in a fixed antagonist protocol. Group A (control group) underwent conventional triggering with hCG 5000 IU and a single oocyte retrieval (OR)
|
Double Pick up Group
n=23 Participants
A single injection of 150mcg of corifollitropin alfa was administrated at day 2/3 of the cycle, followed by 225IU of recombinant FSH (rFSH) in a fixed antagonist protocol. Group B (study group) underwent triggering with GnRHagonist. 225 IU of rFSH was continued after the first oocyte retrieval (OR). Antagonist administration was initiated when at least one follicle measuring ≥14 mm was present on the ultrasound. If one or more follicles ≥17 mm were observed, patients underwent a second triggering with hCG 5000 IU and a second OR was performed. In case of patients with no follicular development following 13 additional days of rFSH.
|
|---|---|---|
|
Number of Cumulus Oocyte Complexes (COCs) Retrieved
|
5.3 number of oocytes
Standard Deviation 2.7
|
3.3 number of oocytes
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 1 monthnumber of fertilized oocytes at day 1 after oocyte retrieval
Outcome measures
| Measure |
Control Group
n=23 Participants
A single injection of 150mcg of corifollitropin alfa was administrated at day 2/3 of the cycle, followed by 225IU of recombinant FSH (rFSH) in a fixed antagonist protocol. Group A (control group) underwent conventional triggering with hCG 5000 IU and a single oocyte retrieval (OR)
|
Double Pick up Group
n=23 Participants
A single injection of 150mcg of corifollitropin alfa was administrated at day 2/3 of the cycle, followed by 225IU of recombinant FSH (rFSH) in a fixed antagonist protocol. Group B (study group) underwent triggering with GnRHagonist. 225 IU of rFSH was continued after the first oocyte retrieval (OR). Antagonist administration was initiated when at least one follicle measuring ≥14 mm was present on the ultrasound. If one or more follicles ≥17 mm were observed, patients underwent a second triggering with hCG 5000 IU and a second OR was performed. In case of patients with no follicular development following 13 additional days of rFSH.
|
|---|---|---|
|
Number of Oocytes Fertilized
|
3.7 number of fertilized oocytes
Standard Deviation 2.4
|
2.3 number of fertilized oocytes
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 1 monthnumber of available embryos at day 3 or day 5 after oocyte retrieval, good quality and therefore transferable
Outcome measures
| Measure |
Control Group
n=23 Participants
A single injection of 150mcg of corifollitropin alfa was administrated at day 2/3 of the cycle, followed by 225IU of recombinant FSH (rFSH) in a fixed antagonist protocol. Group A (control group) underwent conventional triggering with hCG 5000 IU and a single oocyte retrieval (OR)
|
Double Pick up Group
n=23 Participants
A single injection of 150mcg of corifollitropin alfa was administrated at day 2/3 of the cycle, followed by 225IU of recombinant FSH (rFSH) in a fixed antagonist protocol. Group B (study group) underwent triggering with GnRHagonist. 225 IU of rFSH was continued after the first oocyte retrieval (OR). Antagonist administration was initiated when at least one follicle measuring ≥14 mm was present on the ultrasound. If one or more follicles ≥17 mm were observed, patients underwent a second triggering with hCG 5000 IU and a second OR was performed. In case of patients with no follicular development following 13 additional days of rFSH.
|
|---|---|---|
|
Total Number of Available Embryos
|
1.5 number of embryos
Standard Deviation 0.9
|
1.4 number of embryos
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 1 monthnumber of days of ovarian stimulation
Outcome measures
| Measure |
Control Group
n=23 Participants
A single injection of 150mcg of corifollitropin alfa was administrated at day 2/3 of the cycle, followed by 225IU of recombinant FSH (rFSH) in a fixed antagonist protocol. Group A (control group) underwent conventional triggering with hCG 5000 IU and a single oocyte retrieval (OR)
|
Double Pick up Group
n=23 Participants
A single injection of 150mcg of corifollitropin alfa was administrated at day 2/3 of the cycle, followed by 225IU of recombinant FSH (rFSH) in a fixed antagonist protocol. Group B (study group) underwent triggering with GnRHagonist. 225 IU of rFSH was continued after the first oocyte retrieval (OR). Antagonist administration was initiated when at least one follicle measuring ≥14 mm was present on the ultrasound. If one or more follicles ≥17 mm were observed, patients underwent a second triggering with hCG 5000 IU and a second OR was performed. In case of patients with no follicular development following 13 additional days of rFSH.
|
|---|---|---|
|
Duration of Ovarian Stimulation
|
9.9 days
Standard Deviation 2.7
|
9.9 days
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 4 monthsclinical pregnancy rate
Outcome measures
| Measure |
Control Group
n=23 Participants
A single injection of 150mcg of corifollitropin alfa was administrated at day 2/3 of the cycle, followed by 225IU of recombinant FSH (rFSH) in a fixed antagonist protocol. Group A (control group) underwent conventional triggering with hCG 5000 IU and a single oocyte retrieval (OR)
|
Double Pick up Group
n=23 Participants
A single injection of 150mcg of corifollitropin alfa was administrated at day 2/3 of the cycle, followed by 225IU of recombinant FSH (rFSH) in a fixed antagonist protocol. Group B (study group) underwent triggering with GnRHagonist. 225 IU of rFSH was continued after the first oocyte retrieval (OR). Antagonist administration was initiated when at least one follicle measuring ≥14 mm was present on the ultrasound. If one or more follicles ≥17 mm were observed, patients underwent a second triggering with hCG 5000 IU and a second OR was performed. In case of patients with no follicular development following 13 additional days of rFSH.
|
|---|---|---|
|
Clinical Pregnancy Rates
|
7 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 12 monthsnumber of live births
Outcome measures
| Measure |
Control Group
n=23 Participants
A single injection of 150mcg of corifollitropin alfa was administrated at day 2/3 of the cycle, followed by 225IU of recombinant FSH (rFSH) in a fixed antagonist protocol. Group A (control group) underwent conventional triggering with hCG 5000 IU and a single oocyte retrieval (OR)
|
Double Pick up Group
n=23 Participants
A single injection of 150mcg of corifollitropin alfa was administrated at day 2/3 of the cycle, followed by 225IU of recombinant FSH (rFSH) in a fixed antagonist protocol. Group B (study group) underwent triggering with GnRHagonist. 225 IU of rFSH was continued after the first oocyte retrieval (OR). Antagonist administration was initiated when at least one follicle measuring ≥14 mm was present on the ultrasound. If one or more follicles ≥17 mm were observed, patients underwent a second triggering with hCG 5000 IU and a second OR was performed. In case of patients with no follicular development following 13 additional days of rFSH.
|
|---|---|---|
|
Live Birth Rates
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 24 monthsdefined as the first live birth following the transfer of fresh and subsequent frozen-thawed embryos
Outcome measures
Outcome data not reported
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Double Pick up Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place