Evaluation of Efficacy and Safety of Highly Purified Urofollitropin in Chinese Females Undergoing an Assisted Reproductive Technology (ART) Program

NCT01922193 | Completed Phase 3

• 1 other identifier: 000089
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 11

Brief Summary

Evaluate the efficacy and safety of of Highly Purified Urofollitropin for Injection Compared to Recombinant Human Follitropin Alfa for Injection in Chinese Females Undergoing an Assisted Reproductive Technology (ART) Program.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• The number of retrieved oocytes per cycle

  About 36 hours post hCG (human chorionic gonadotrophin)

Secondary Outcomes (12)

• The follicles development

  At day 5 of FSH preparation stimulation and the day of hCG administration

• The fertilization rate

  20h (± 1h) after insemination

• Implantation rate

  5-6 weeks post embryo transfer

• Cycle cancellation rate

  36 hours post hCG

• The positive serum β-hCG/hCG rate

  13-15 days after embryo transfer

Study Arms (2)

Test Group

EXPERIMENTAL

Drug: Highly Purified Urofollitropin

Control Group

ACTIVE COMPARATOR

Drug: Recombinant Human Follitropin Alfa

Interventions

Highly Purified Urofollitropin DRUG

for injection

Also known as: Bravelle®

Test Group

Recombinant Human Follitropin Alfa DRUG

for injection

Also known as: Gonal-F®

Control Group

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent form, prior to screening evaluations
• In good physical and mental health
• Chinese Females between the ages of 20-39 years.
• Body mass index (BMI) is ≥ 18.5 and \< 28 kg/m2
• Female diagnosed for at least one year (i.e., before screening) with tubal infertility, unexplained infertility, male factor infertility
• Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory
• Documented evidence of at least one of the following within ninety (90) days prior to down regulation treatment:
• mid-luteal phase serum progesterone level \> 5ng/mL, or
• late luteal phase endometrial biopsy with \< 3 days lag, or
• biphasic basal body temperature chart, or
• mid-cycle urinary LH (Luteinizing hormone)surge
• Early follicular phase (day 2-3), serum levels of FSH within limits (1-12IU/L)(results obtained within 90 days prior to down regulation treatment)
• LH, PRL (prolactin), E2 (Estradiol), P (progesterone), total testosterone levels within normal range for the clinical laboratory or considered not clinically significant by the investigator (results obtained within 90 days prior to down regulation treatment)
• TSH (thyrotropin) levels within normal limits for the clinical laboratory or considered not clinically significant by the investigator, or secondary to exogenous thyroid medication (results obtained within 90 days prior to down regulation treatment)
• Negative serum Human Immunodeficiency Virus (HIV) antibody, and TPPA (Treponema Pallidum antibodies)/ RPR (Rapid Plasma Reagin) tests (results obtained within 90 days prior to down regulation treatment)

You may not qualify if:

• Any pregnancy within last three (3) months prior to screening
• Known past or current thrombophlebitis or thromboembolism including venous thrombosis disease and active or recent arterial thrombosis disease
• Three or more controlled ovarian stimulation cycles for IVF/ICSI (In vitro fertilization/Intracytoplasmic sperm injection) prior to screening
• Previous IVF or ART failure related to a sperm/fertilization problem which resulted in unsuccessful fertilization and no related medical conditions improved
• Known history of poor ovarian response in a previous controlled ovarian stimulation cycle for IVF/ICSI
• Known history of excessive ovarian response in a previous controlled ovarian stimulation cycle for IVF/ICSI
• Known severe OHSS (Ovarian hyperstimulating syndrome) in a previous controlled ovarian stimulation cycle.
• Known history of polycystic ovary disease (PCOD) associated with anovulation
• Known endometriosis
• Known abnormal results of cervical examination of clinical significance obtained within 1 year prior to screening
• Abnormal vaginal bleeding of undetermined origin
• Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
• Known current active pelvic inflammatory disease
• Known history of recurrent miscarriage
• Known malformations of the sexual organs incompatible with pregnancy

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (11)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

Sun Yat-sen Memorial Hospital Sun Yat-sen University

Guangzhou, Guangdong, China

Location

The third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Tongji Hospital Tongji Medical College of HUST Tongji Medical College Huazhong University of Science & Technology

Wuhan, Hubei, China

Location

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Location

ShengJing Hospital of China Medical University

Shenyang, Liaoning, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Infertility

Interventions

Urofollitropin; follitropin alfa

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Menotropins; Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: August 14, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 16, 2015

Record last verified: 2015-06

Locations

CN (11)