Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Number of Oocytes Retrieved |
The number of oocytes retrieved was recorded at the oocyte retrieval visit. |
On day of oocyte retrieval (up to 22 days after start of stimulation) |
|
Secondary |
Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response |
For each participant, the reason for cycle cancellation was recorded |
At end-of-stimulation (up to 20 days) |
|
Secondary |
Proportion of Subjects With Blastocyst Transfer Cancellation After Oocyte Retrieval Due to (Risk of) Ovarian Hyperstimulation Syndrome (OHSS) |
For each participant, the reason for blastocyst transfer cancellation was recorded. |
At end of transfer (up to 4 weeks) |
|
Secondary |
Number of Follicles |
The total number of follicles and the number of follicles per size category will be reported |
On stimulation day 6 and at end-of-stimulation (up to 20 days) |
|
Secondary |
Proportion of Subjects With <4, 4-7, 8-14, 15-19 and =20 Oocytes Retrieved |
Grouped according to number of oocytes |
On day of oocyte retrieval (up to 22 days after start of stimulation) |
|
Secondary |
Number of Metaphase II Oocytes |
Only applicable for those inseminated using ICSI |
On day of oocyte retrieval (up to 22 days after start of stimulation) |
|
Secondary |
Fertilization Rate |
Measured by the number of pronuclei. Fertilized oocytes with 2 pronuclei were regarded as correctly fertilized |
On day 1 after oocyte retrieval (up to 23 days after start of stimulation) |
|
Secondary |
Number of Embryos |
The number of embryos (total and good-quality) was reported. Embryo quality is determined by combined assessment of cleavage stage (number of blastomeres/compaction status) and embryo morphology parameters |
On day 3 after oocyte retrieval (up to 25 days after start of stimulation) |
|
Secondary |
Number of Blastocysts |
The number of blastocysts (total and good-quality) was reported. Blastocyst quality is assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring is based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cells) |
On day 5 after oocyte retrieval (up to 27 days after start of stimulation) |
|
Secondary |
Circulating Concentrations of Follicle-stimulating Hormone (FSH) |
Blood samples for analysis of circulating concentrations of FSH were drawn. |
On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation) |
|
Secondary |
Circulating Concentrations of Luteinizing Hormone (LH) |
Blood samples for analysis of circulating concentrations of LH were drawn |
On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation) |
|
Secondary |
Circulating Concentrations of Estradiol |
Blood samples for analysis of circulating concentrations of estradiol were drawn |
On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation) |
|
Secondary |
Circulating Concentrations of Progesterone |
Blood samples for analysis of circulating concentrations of progesterone were drawn |
On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation) |
|
Secondary |
Circulating Concentrations of Inhibin B |
Blood samples for analysis of circulating concentrations of Inhibin B were drawn |
On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation) |
|
Secondary |
Total Gonadotropin Dose |
Calculated by start dates, end dates and daily dose of investigational medicinal product |
Up to 20 days |
|
Secondary |
Number of Stimulation Days |
Calculated by start dates and end dates |
Up to 20 days |
|
Secondary |
Positive Beta Human Chorionic Gonadotropin (ßhCG) Rate |
Defined as positive serum ßhCG test |
13-15 days after transfer (up to approximately 1.5 months after start of stimulation) |
|
Secondary |
Implantation Rate |
Defined as the number of gestational sacs after transfer divided by number of blastocysts transferred |
5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation) |
|
Secondary |
Clinical Pregnancy Rate |
Defined as at least one gestational sac |
5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation) |
|
Secondary |
Vital Pregnancy Rate |
Defined as at least one intrauterine gestational sac with fetal heart beat |
5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation) |
|
Secondary |
Ongoing Pregnancy Rate |
At least one intrauterine viable fetus |
10-11 weeks after transfer (up to approximately 4 months after start of stimulation) |
|
Secondary |
Ongoing Implantation Rate |
Defined as number of intrauterine viable fetuses divided by the number of blastocysts transferred |
10-11 weeks after transfer (up to approximately 4 months after start of stimulation) |
|
Secondary |
Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) |
Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe. |
Up to 9 days after triggering of final follicular maturation |
|
Secondary |
Proportion of Subjects With Late OHSS (Including OHSS of Moderate/Severe Grade) |
Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe. |
>9 days after triggering of final follicular maturation |
|
Secondary |
Frequency of Adverse Events |
Any untoward medical occurrence |
From time of signing informed consent until the end-of-trial (approximately 7 months) |
|
Secondary |
Intensity of Adverse Events |
Categorized as mild, moderate or severe |
From time of signing informed consent until the end-of-trial (approximately 7 months) |
|
Secondary |
Technical Malfunctions of the Pre-filled Injection Pen |
Incidences of technical malfunctions of the pre-filled injection pen were recorded |
Up to 20 days |
|