Trial Outcomes & Findings for Continuous Double Ovarian Stimulation. (NCT NCT05815719)
NCT ID: NCT05815719
Last Updated: 2025-05-18
Results Overview
To investigate the total number of oocytes retrieved through ovarian stimulation in double ovarian stimulation cycles (DUOSTIM) utilizing weekly subcutaneous injections of Corifollitropin alfa (study group) vs. daily injections of gonadotropins (control group).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
Through study completion, an average of four weeks
Results posted on
2025-05-18
Participant Flow
Enrolled patients all had to comply with the entry criteria and were all assiged to the "study group". The "control group" subjects were selected restrospectively by also complying with the criteria and with similar characteristics (such as AMH level, BMI, age) to the "study group" ones.
Participant milestones
| Measure |
Study Group
Patients to carry out an experimental double ovarian stimulation and to receive 4 weekly injections of Corifollitropin alfa. Prospective group.
Corifollitropin Alfa: 150 micrograms per dose
|
Control Group
Patients to carry out a conventional double ovarian stimulation and to receive daily injections of gonadotropins. Retrospective group (data retrieved from strictly selected treatments carried out in our institution within the 24 months prior to the inclusion of the first patient in the study group and according to the standard guideline of the clinic).
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Continuous Double Ovarian Stimulation.
Baseline characteristics by cohort
| Measure |
Study Group
n=15 Participants
Patients to carry out an experimental double ovarian stimulation and to receive 4 weekly injections of Corifollitropin alfa. Prospective group.
Corifollitropin Alfa: 150 micrograms per dose
|
Control Group
n=15 Participants
Patients to carry out a conventional double ovarian stimulation and to receive daily injections of gonadotropins. Retrospective group (data retrieved from strictly selected treatments carried out in our institution within the 24 months prior to the inclusion of the first patient in the study group and according to the standard guideline of the clinic).
Follitropin Alfa: Variable dose.
Follitropin Alfa Biosimilar: Variable dose.
Urinary Human follicle stimulating hormone: Variable dose.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
15 participants
n=93 Participants
|
15 participants
n=4 Participants
|
30 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of four weeksTo investigate the total number of oocytes retrieved through ovarian stimulation in double ovarian stimulation cycles (DUOSTIM) utilizing weekly subcutaneous injections of Corifollitropin alfa (study group) vs. daily injections of gonadotropins (control group).
Outcome measures
| Measure |
Study Group
n=15 Participants
Patients to carry out an experimental double ovarian stimulation and to receive 4 weekly injections of Corifollitropin alfa. Prospective group.
Corifollitropin Alfa: 150 micrograms per dose
|
Control Group
n=15 Participants
Patients that have carried out standard double ovarian stimulation and received daily injections of gonadotropins. Retropective group.
|
|---|---|---|
|
Total Number of Retrieved Oocytes
|
13.33 oocytes
Standard Deviation 6.904
|
11.87 oocytes
Standard Deviation 6.105
|
PRIMARY outcome
Timeframe: Through study completion, an average of four monthsTo compare the total number of MII oocytes obtained in double stimulation cycles in study vs control groups
Outcome measures
| Measure |
Study Group
n=15 Participants
Patients to carry out an experimental double ovarian stimulation and to receive 4 weekly injections of Corifollitropin alfa. Prospective group.
Corifollitropin Alfa: 150 micrograms per dose
|
Control Group
n=15 Participants
Patients that have carried out standard double ovarian stimulation and received daily injections of gonadotropins. Retropective group.
|
|---|---|---|
|
Number of MII Oocytes
|
10.4 oocytes
Standard Deviation 6.3
|
9.2 oocytes
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Through study completion, an average of four monthsTotal days of follicular and luteal phases
Outcome measures
| Measure |
Study Group
n=15 Participants
Patients to carry out an experimental double ovarian stimulation and to receive 4 weekly injections of Corifollitropin alfa. Prospective group.
Corifollitropin Alfa: 150 micrograms per dose
|
Control Group
n=15 Participants
Patients that have carried out standard double ovarian stimulation and received daily injections of gonadotropins. Retropective group.
|
|---|---|---|
|
Duration of Ovarian Stimulation
|
24.4 days
Standard Deviation 3.5
|
25.2 days
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Through study completion, an average of four monthsNumber of injections during the DUOSTIM cycle
Outcome measures
| Measure |
Study Group
n=15 Participants
Patients to carry out an experimental double ovarian stimulation and to receive 4 weekly injections of Corifollitropin alfa. Prospective group.
Corifollitropin Alfa: 150 micrograms per dose
|
Control Group
n=15 Participants
Patients that have carried out standard double ovarian stimulation and received daily injections of gonadotropins. Retropective group.
|
|---|---|---|
|
Number of Injections
|
4.5 injections
Standard Deviation 1.4
|
35.2 injections
Standard Deviation 12.2
|
Adverse Events
Study Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control 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