The overall objective of this trial is to compare the ovarian response in assisted reproductive technology (ART) subjects administered GONAL f® according to the 'Consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment' (CONSORT) calculator versus given a standard GONAL f® dose of 150 International Unit (IU) per day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
GONAL f® doses starting at minimum of 112.5 IU per day and a maximum of 450 IU per day for 1 cycle only
GONAL f® standard treatment arm (150 IU of GONAL f® per day) up to Day 5 of stimulation after which the dose can be adjusted based upon the subject's ovarian response and according to the center's standard practice.
Research Site
Geneva, Switzerland
Number of Oocytes Retrieved Per Participant
Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.
Time frame: 34-38 hours post-recombinant human choriogonadotropin (hCG) (OPU)
Total GONAL-f® Dose
Time frame: Start of treatment until end of stimulation cycle (approximately 28 days)
Mean GONAL-f® Daily Dose
Time frame: Start of treatment until end of stimulation cycle (approximately 28 days)
Total Number of GONAL-f® Stimulation Treatment Days
Time frame: Start of treatment until end of stimulation cycle (approximately 28 days)
Number of Participants With Cancelled Cycles Due to Excessive or Inadequate Response to Treatment
Number of participants with cancelled cycles due to excessive or inadequate response was evaluated. An excessive response: greater than or equal to 25 oocytes which could put the participant at risk of OHSS; An inadequate response: defined as 3 or less follicles of greater than or equal to 12 millimeter (mm) developing following at least 7 days of GONAL-f® treatment.
Time frame: Start of treatment until Day 15-20 post-hCG
Percentage of Participants With Biochemical Pregnancies
Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum and that does not develop into a clinical pregnancy.
Time frame: Start of treatment until Day 15-20 Post-hCG
Number of Participants With Fetal Sacs and Fetal Hearts
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Number of participants with fetal sacs and fetal hearts (with activity) as seen on an ultrasound scan to confirm clinical pregnancy.
Time frame: Day 35-42 Post-hCG
Implantation Rate
Implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.
Time frame: Day 35-42 Post-hCG
Number of Participants With Multiple Pregnancies
Multiple pregnancy was defined as 2 or more fetal hearts with activity.
Time frame: Day 35-42 Post-hCG
Serum Progesterone (P4) Levels
Time frame: End of stimulation cycle (approximately 28 days)
Percentage of Participants With Clinical Pregnancy
Clinical pregnancy is defined by the number of sacs and hearts with activity per ultrasound scan performed on Day 35-42 post-hCG.
Time frame: Day 35-42 Post-hCG
Number of Participants With OHSS
OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.
Time frame: Start of treatment until Day 15-20 Post-hCG
Pregnancy Outcome - Number of Participants With Pregnancy and Their Outcome
Pregnancy outcomes are live outcome (live infant) and non-live outcome (non-live infant) or unknown outcome (subject lost to follow-up).
Time frame: up to 9 month (following the end of treatment)