This is a prospective, multicenter, open-label, comparative and parallel-group study of ovulation induction evaluating tailoring of Recombinant follicle stimulating hormone (FSH) treatment using the Gonal-f® prefilled pen in World Health Organization (WHO) Type 2 anovulatory subjects who have previously failed to conceive with clomifene treatment.
Subjects will enter a screening period of up to one month before being randomized at the Baseline Visit, which will occur on Day 1 of the subject's menstrual cycle. Each subject will then receive up to 4 weeks treatment with Gonal-f®. If adequate follicular development (assessed by transvaginal ultrasound) is achieved, the subject will proceed to administration of human chorionic gonadotropin (hCG) within 24-48hrs of last Gonal-f® injection (or according to standard site practice). Following administration of hCG, subjects will attempt to become pregnant via intercourse or intrauterine insemination. The method of conception will be determined by the subject's requirements and standard practice at the clinic site. All subjects will be followed up appropriately until confirmation of biochemical pregnancy (hCG + minimum 14 days) and clinical pregnancy (hCG + minimum 42 days, for subjects with positive biochemical pregnancy test).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Research Site
Cork, Ireland
Research Site
Dublin, Ireland
Research Site
Galway, Ireland
Research Site
Cambridge, United Kingdom
Percentage of Cycles With Monofollicular Development
The monofollicular development was defined as the number of cycles with monofollicular development only one Follicle Greater Than or Equal (\>= to 17 millimeter (mm) and no other follicles Greater than or equal to 14 mm following up to 4 weeks Gonal-f treatment.
Time frame: Baseline up to 4 weeks
Percentage of Cycles With Bifollicular Development
The bifollicular development was defined as the number of cycles with bifollicular development of only two follicles greater than or equal to 17 millimeter.
Time frame: Baseline up to 4 weeks
Percentage of Cycles With Multifollicular Development
The multifollicular development was defined as the number of cycles with multifollicular development of three or more follicles greater than or equal to 14 millimeter
Time frame: Baseline up to 4 weeks
Percentage of Ovulatory Cycles
Ovulation was defined as a serum progesterone (P4 ) level greater than or equal to 10 nanogram per milliliter (ng/mL) or Clinical Pregnancy. Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.
Time frame: Baseline up to 42 days post human chorionic gonadotrophin (hCG) administration
Percentage of Cycles Wherein Human Chorionic Gonadotropin (hCG) Was Not Administered
Time frame: Baseline up to 4 weeks
Percentage of Cycles Resulting in Clinical Pregnancy
Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.
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Research site
Cheshunt, United Kingdom
Research Site
Derby, United Kingdom
Research Site
Edinburgh, United Kingdom
Research Site
Glasgow, United Kingdom
Research site
London, United Kingdom
Research Site
Nottingham, United Kingdom
Time frame: 35-42 days post hCG administration
Number of Multiple Pregnancy
Multiple pregnancy is a pregnancy where more than one fetus develops simultaneously in the womb. There are two types of twinning-identical and fraternal. Identical twins represent the splitting of a single fertilized zygote (union of two gametes or male/female sex cells that produce a developing fetus) into two separate individuals.
Time frame: 35-42 days post hCG administration
Number of Fetuses
Time frame: 35-42 days post hCG administration
Number of Miscarriages After Confirmation of Clinical Pregnancy
Miscarriages were calculated per clinical pregnancy, and clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or confirmed by clinical signs of pregnancy. It excludes ectopic pregnancy.
Time frame: 35-42 days post hCG administration
Number of Subjects With Ovarian Hyper Stimulation Syndrome (OHSS)
OHSS was defined as an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations, classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, hemodynamic and metabolic complications.
Time frame: up to 42 days post hCG administration
Duration of Recombinant Follicle Stimulating Hormone (rFSH) Stimulation
Time frame: Baseline up to 4 weeks
Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH) Administered Per Cycle
Time frame: Baseline up to 4 weeks
Change From Baseline in Anti-Mullerian Hormone (AMH) Levels at Week 4
Time frame: Baseline, Week 4
Testosterone Levels
Time frame: Baseline
Sex Hormone Binding Globulin (SHBG) Levels
Time frame: Baseline