This trial is investigating the efficacy and safety of highly purified human chorionic gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of final follicular maturation in women undergoing controlled ovarian stimulation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
176
Instituto Ideia Fértil de Saúde Reproductive (there may be other sites in this country)
São Paulo, Brazil
Number of Oocytes Retrieved
Oocyte retrieval took place 36 h (±2h) after hCG administration. At oocyte retrieval the number of oocytes retrieved was recorded.
Time frame: Approximately 36 hours after hCG administration
Number of Metaphase II (MII) Oocytes
Only applicable for insemination using intracytoplasmic sperm injection (ICSI). The MII oocytes were counted prior to insemination.
Time frame: Prior to insemination (within 6 hours after oocyte retrieval)
Number of Fertilized (2 Pronuclei (2PN)) Oocytes
Fertilization was assessed by counting the number of pronuclei, which was recorded as 0, 1, 2 or \>2. Correct fertilization was defined as oocytes with 2PN.
Time frame: One day after oocyte retrieval
Positive β Unit of Human Chorionic Gonadotropin (βhCG) Rate
Defined as percentage of subjects with positive beta hCG. A positive β hCG was confirmed by a blood test obtained 13-15 days after transfer.
Time frame: 13-15 days after transfer
Clinical Pregnancy Rate
Defined as percentage of subjects with clinical pregnancy. Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer.
Time frame: 5-6 weeks after transfer
Frequency of Adverse Events (AEs)
The number of treatment-emergent AEs (TEAEs) in each treatment group will be presented.
Time frame: AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented
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Intensity of AEs
The intensity of an TEAE would be classified using the following 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity \[disturbing\]) or severe (inability to work or perform usual activities \[unacceptable\]).
Time frame: AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented.