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

August 20, 2015 updated by: Ferring Pharmaceuticals

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
215

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Peking Union Medical College Hospital
      • Beijing, Beijing, China
        • Peking University First Hospital
      • Beijing, Beijing, China
        • Chinese PLA General Hospital
      • Beijing, Beijing, China
        • Navy General Hospital
      • Beijing, Beijing, China
        • Peking University People's Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • Sun Yat-sen Memorial Hospital Sun Yat-sen University
      • Guangzhou, Guangdong, China
        • The Third Affiliated Hospital of Guangzhou Medical University
    • Hubei
      • Wuhan, Hubei, China
        • Tongji Hospital Tongji Medical College of HUST Tongji Medical College Huazhong University of Science & Technology
    • Jiangsu
      • Nanjing, Jiangsu, China
        • The First Affiliated Hospital with Nanjing Medical University
    • Liaoning
      • Shenyang, Liaoning, China
        • Shengjing Hospital of China Medical University
    • Sichuan
      • Chengdu, Sichuan, China
        • Sichuan Provincial People's Hospital
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Medical University General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test Group
Drug: Highly Purified Urofollitropin
for Injection
Other Names:
  • Bravelle®
Active Comparator: Comparator Group
Drug: Recombinant Human Follitropin Alfa
for Injection
Other Names:
  • Gonal-F®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The ovulation rate defined as the percentage of subjects who present ovulation
Time Frame: From 6 days up to 7 weeks post hCG (human chorionic gonadotropin) administration
From 6 days up to 7 weeks post hCG (human chorionic gonadotropin) administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The positive serum progesterone rate
Time Frame: 6~9 days post hCG administration
6~9 days post hCG administration
The positive serum β-hCG/hCG rate
Time Frame: 18~22 days post hCG administration
18~22 days post hCG administration
The clinical pregnancy rate
Time Frame: 6~7 weeks post hCG administration
Regardless of fetal heart beat
6~7 weeks post hCG administration
The clinical pregnancy rate
Time Frame: 6~7 weeks post hCG administration
With fetal heart beat
6~7 weeks post hCG administration
The ongoing pregnancy rate
Time Frame: 11~12 weeks post hCG administration
11~12 weeks post hCG administration
The follicular development
Time Frame: On the day of hCG administration
On the day of hCG administration
Endometrial thickness
Time Frame: On the day of hCG administration
On the day of hCG administration
Total FSH (Follicle-stimulating hormone) dose administered
Time Frame: On the day of hCG administration
On the day of hCG administration
Number of FSH treatment days
Time Frame: On the day of hCG administration
On the day of hCG administration
Frequency and severity of adverse events
Time Frame: Expected maximum of 6 months
Expected maximum of 6 months
Frequency and severity of injection site reactions
Time Frame: Day 1 up to Day 28 of the ovarian stimulation period
Day 1 up to Day 28 of the ovarian stimulation period
Serum estradiol (E2) levels
Time Frame: On the day of hCG administration
On the day of hCG administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 000055

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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