Evaluation of Efficacy and Safety of Highly Purified Urofollitropin for Ovulation Induction in Chinese Females

Study Overview
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Brief Summary
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Evaluate the Efficacy and Safety of Highly Purified Urofollitropin for Injection Compared to Recombinant Human Follitropin Alfa for Injection for Ovulation Induction in Chinese females

Official Title
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A Randomized, Assessor-blinded, Parallel Group, Multi-center, Non-inferiority Study Investigating the Efficacy and Safety of Highly Purified Urofollitropin for Injection Compared to Recombinant Human Follitropin Alfa for Injection for Ovulation Induction Using a Low-dose, Step-up Protocol in Chinese Females With WHO Group II Anovulatory Infertility Failing to Conceive on Clomiphene Citrate

Conditions
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Anovulation

Intervention / Treatment
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* Drug: Highly Purified Urofollitropin
* Drug: Recombinant Human Follitropin Alfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent form prior to screening evaluations Chinese females between the ages of 20-39 years Infertility for at least 1 year before screening Women WHO type II anovulatory infertility with chronic anovulation (defined as amenorrhoea (i.e., no menstrual bleeding for 6 months or more) or oligoamenorrhoea (i.e., cycles of more than 35 days) ) with progestogen induced withdrawal bleeding or spontaneous menstrual bleeding Failure to conceive after at least one cycle of ovulation induction with clomiphene citrate Bilateral tubal patency documented by a hysterosalpingography or sonohysterography or laparoscopy within 2 years prior to screening Normal pelvis documented by a transvaginal ultrasound with respect to uterus, Fallopian tubes and ovaries within 3 months prior to screening Early follicular phase serum levels of FSH within normal limits (1-12 IU/L,) (results obtained within 2 months prior to randomization) LH (Luteinizing hormone), prolactin , E2 (estradiol), progesteron, total testosterone, and TSH (thyrotropin) levels within normal limits for the clinical laboratory Male partner with a semen analysis obtained within 12 months prior to randomisation and showing acceptable values for semen according to the local laboratory, or showing more than 2.000.000 progressive motile sperm per mL after capacitation (in case of IUI (intrauterine insemination)) BMI (Body mass index) is ≥ 18.5 and < 30 kg/m2 Exclusion Criteria: Any known clinically significant systemic disease Known past or current thrombophlebitis or thromboembolism including venous thrombosis disease and active or recent arterial thrombosis disease Any known endocrine or metabolic abnormalities which can compromise participation in the trial with the exception of controlled thyroid function disease Any known concomitant medications that would interfere with evaluation of study medications. Specifically, any non-study hormonal therapy (except for thyroid medication), anti-psychotics, anxiolytics, hypnotics and sedatives, and need for continuous use of prostaglandin inhibitors (non-steroid anti- inflammatory drugs (NSAIDs), including aspirin) at the time of study entry. Known history of 12 or more unsuccessful (no pregnancy achieved) ovulation induction cycles Any known treatment with clomiphene citrate, metformin, gonadotropins or GnRH analogues within one month prior to randomisation Ovarian cysts with a mean diameter ≥ 15 mm that have persisted for more than one cycle or ovarian endometrioma on ultrasound Known at least one previous cycle experienced luteinized unruptured follicle syndrome Known abnormal results of cervical examination of clinical significance obtained within 1 years prior to screening Abnormal vaginal bleeding of undetermined origin Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus Known malformations of the sexual organs incompatible with pregnancy Known current or past (last 12 months) abuse of alcohol or drugs Known history of chemotherapy (except for gestational conditions) or radiotherapy Finding of any clinically relevant abnormal laboratory value Use of any non registered investigational drugs during 3 months before screening or previous participation in the study Pregnancy, lactation or contraindication to pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br> | Drug: Highly Purified Urofollitropin<br>* for Injection<br>* Other names: Bravelle®;|
| Active Comparator: Comparator Group<br> | Drug: Recombinant Human Follitropin Alfa<br>* for Injection<br>* Other names: Gonal-F®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ovulation rate defined as the percentage of subjects who present ovulation |  | From 6 days up to 7 weeks post hCG (human chorionic gonadotropin) administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The positive serum progesterone rate |  | 6 9 days post hCG administration | 
| The positive serum β-hCG/hCG rate |  | 18 22 days post hCG administration | 
| The clinical pregnancy rate | Regardless of fetal heart beat | 6 7 weeks post hCG administration | 
| The clinical pregnancy rate | With fetal heart beat | 6 7 weeks post hCG administration | 
| The ongoing pregnancy rate |  | 11 12 weeks post hCG administration | 
| The follicular development |  | On the day of hCG administration | 
| Endometrial thickness |  | On the day of hCG administration | 
| Total FSH (Follicle-stimulating hormone) dose administered |  | On the day of hCG administration | 
| Number of FSH treatment days |  | On the day of hCG administration | 
| Frequency and severity of adverse events |  | Expected maximum of 6 months | 
| Frequency and severity of injection site reactions |  | Day 1 up to Day 28 of the ovarian stimulation period | 
| Serum estradiol (E2) levels |  | On the day of hCG administration |