Evaluation of Efficacy and Safety of Highly Purified Urofollitropin for Ovulation Induction in Chinese Females
Phase 3
Completed
- Conditions
- Anovulation
- Interventions
- Registration Number
- NCT01923194
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 215
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comparator Group Recombinant Human Follitropin Alfa - Test Group Highly Purified Urofollitropin -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Frequency and severity of injection site reactions Day 1 up to Day 28 of the ovarian stimulation period Endometrial thickness On the day of hCG administration The positive serum progesterone rate 6~9 days post hCG administration Total FSH (Follicle-stimulating hormone) dose administered On the day of hCG administration The clinical pregnancy rate 6~7 weeks post hCG administration With fetal heart beat
The follicular development On the day of hCG administration The ongoing pregnancy rate 11~12 weeks post hCG administration The positive serum β-hCG/hCG rate 18~22 days post hCG administration Frequency and severity of adverse events Expected maximum of 6 months Number of FSH treatment days On the day of hCG administration Serum estradiol (E2) levels On the day of hCG administration
Trial Locations
- Locations (12)
Navy General Hospital
🇨🇳Beijing, Beijing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital with Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Sun Yat-sen Memorial Hospital Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The Third Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Tongji Hospital Tongji Medical College of HUST Tongji Medical College Huazhong University of Science & Technology
🇨🇳Wuhan, Hubei, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
ShengJing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China