This was a prospective, open, non-comparative study to evaluate the safety and efficacy of recombinant human luteinizing hormone (rhLH, Luveris) administered subcutaneously (s.c.) in follicular development during ovulation induction in 31 Chinese female subjects with hypogonadotropic hypogonadism.
The objective of this prospective, open, non-comparative study was to assess the safety and efficacy of rhLH (Luveris) administered subcutaneously in follicular development during ovulation induction in Chinese female subjects with hypogonadotropic hypogonadism. The study was organized on an outpatient basis involving a single cycle of treatment. Prior to entry into the study, the diagnosis of hypogonadotropic hypogonadism was confirmed by history, by the presence or absence of specific clinical features and by measuring serum gonadotropin levels. Once a subject has signed the informed consent form and after satisfying all eligibility criteria, the subject received a combination of daily injection of recombinant human follicle-stimulating hormone (rhFSH) 150 international units (IU) plus rhLH 75 IU. After adequate follicular response, ovulation induction was triggered by an injection of 10,000 IU human chorionic gonadotropin (hCG). Luteal phase function was assessed by serum progesterone level determination.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
One r-hLH (75 International Units \[IU\]) injection s.c. once daily.
One r-hFSH (150 IU) injection s.c. once daily.
After adequate follicular response, ovulation induction was triggered by an injection of 10,000 IU hCG.
Peking Union Medical College Hospital
Beijing, China
Number of Participants Who Met Both Index 1 and Index 2
The three indices were defined as; Index 1: diameter of at least one follicle is greater than 17 mm; Index 2: serum oestradiol (E2) level in blood serum above 109 picogram/ milliliter (pg/mL) on human chorionic gonadotropin (hCG) injection day; Index 3: participant refuses to take hCG injection for the concern of ovarian hyperstimulation syndrome (OHSS) or participant is pregnant. A subset of these participants met Index 3.
Time frame: Day 14
Number of Participants Who Had at Least One Follicle Greater Than 17mm in Diameter
Time frame: Day 14
Number of Participants With E2 Level in Blood Serum Above 109 pg/mL on the Day of hCG Injection
Time frame: Day 14
Number of Participants Who Refused to Take hCG Injection
Participant refused to take hCG injection for the concern of OHSS or the participant was pregnant.
Time frame: Day 14
Mean Number of Follicles With Diameter in the Range of 10-17 mm on the Day of hCG Injection in Treatment Cycle
Time frame: Day 14
Mean Number of Follicles With the Diameter Above 17 mm on the Day of hCG Injection in Treatment Cycle
Time frame: Day 14
Average Change of E2 Level in Participants Per Day up to Day 14
The average change was calculated by assessing the E2 levels on 4 timepoints until day 14 (day 1, day 5, day 10, day 14 \[hCG administration day\]).
Time frame: up to Day 14
Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies
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Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy. Clinical pregnancy was defined as a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.
Time frame: Day 14
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.
Time frame: Day 14