Fertility Issues
Conditions
Keywords
OVARIAN STIMULATION
Brief summary
To evaluate the efficacy of the weekly use of corifollitropin alfa in double ovarian stimulation process and to compare it to the conventional protocol with daily medication administration.
Detailed description
The purpose of this pilot study is to evaluate the efficacy of the weekly use of corifollitropin alfa in terms of ovarian stimulation results and its biological outcomes (total number of oocytes retrieved) in case of ovarian stimulation cycles in double stimulation modality (DUOSTIM) and in comparison with the conventional DUOSTIM protocol: daily administration of gonadotropins.
Interventions
DRUGCorifollitropin Alfa
150 micrograms per dose
DRUGFollitropin Alfa
Variable dose.
DRUGFollitropin Alfa Biosimilar
Variable dose.
DRUGUrinary Human follicle stimulating hormone
Variable dose.
Sponsors
Instituto Bernabeu
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with indication for DUOSTIM protocol * Maximum age of 43 years (up to one day before their 44th birthday) at the beginning of the stimulation process. * Ability to participate and comply with the study protocol. * To have given written consent
Exclusion criteria
* Finding of ovarian pathology at the time of initiation of stimulation: e.g. ovarian cysts. * Concurrent participation in another study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Retrieved Oocytes | Through study completion, an average of four weeks | 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). |
| Number of MII Oocytes | Through study completion, an average of four months | To compare the total number of MII oocytes obtained in double stimulation cycles in study vs control groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Ovarian Stimulation | Through study completion, an average of four months | Total days of follicular and luteal phases |
| Number of Injections | Through study completion, an average of four months | Number of injections during the DUOSTIM cycle |
Countries
Spain
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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).
Follitropin Alfa: Variable dose.
Follitropin Alfa Biosimilar: Variable dose.
Urinary Human follicle stimulating hormone: Variable dose. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Study Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 30 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 15 Participants | 30 Participants |
| Region of Enrollment Spain | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Number of MII Oocytes
To compare the total number of MII oocytes obtained in double stimulation cycles in study vs control groups
Time frame: Through study completion, an average of four months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group | Number of MII Oocytes | 10.4 oocytes | Standard Deviation 6.3 |
| Control Group | Number of MII Oocytes | 9.2 oocytes | Standard Deviation 4.6 |
Primary
Total Number of Retrieved Oocytes
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).
Time frame: Through study completion, an average of four weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group | Total Number of Retrieved Oocytes | 13.33 oocytes | Standard Deviation 6.904 |
| Control Group | Total Number of Retrieved Oocytes | 11.87 oocytes | Standard Deviation 6.105 |
Secondary
Duration of Ovarian Stimulation
Total days of follicular and luteal phases
Time frame: Through study completion, an average of four months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group | Duration of Ovarian Stimulation | 24.4 days | Standard Deviation 3.5 |
| Control Group | Duration of Ovarian Stimulation | 25.2 days | Standard Deviation 4.9 |
Secondary
Number of Injections
Number of injections during the DUOSTIM cycle
Time frame: Through study completion, an average of four months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group | Number of Injections | 4.5 injections | Standard Deviation 1.4 |
| Control Group | Number of Injections | 35.2 injections | Standard Deviation 12.2 |