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InfertilityPhase 3NCT01922193

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

A Phase 3 study testing Highly Purified Urofollitropin and Recombinant Human Follitropin Alfa in people with Infertility, run by Ferring Pharmaceuticals at 11 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 39 years, women only
Conditions the study is for
Infertility
What is being tested?
Highly Purified Urofollitropin and Recombinant Human Follitropin Alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
263 participants
Where
11 sitesChina
Study dates
Oct 2013to Apr 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 39 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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)
  • Early follicular phase total antral follicle (diameter 2-10 mm) count ≥ 6 and ≤ 25 for both ovaries combined (results obtained within 3 months prior to down regulation treatment)
  • Transvaginal ultrasound documenting presence and adequate visualisation of both ovaries, uterus and adnexa without evidence of significant abnormality (e.g.no endometrioma greater than 3 cm, no ovarian cysts > 35 mm or enlarged ovaries which would contraindicate the use of down regulation treatment, no hydrosalpinx) within ninety (90) days prior to down regulation treatment
  • Hysterosalpingography, hysteroscopy, saline infusion sonography or transvaginal ultrasound documenting a uterus consistent with expected normal function (e.g.no evidence of clinically interfering uterine fibroids defined as submucous or intramural fibroids larger than 3 cm in diameter, no polyps and no congenital structural abnormalities which are incompatible with pregnancy) within 1 year prior to down regulation treatment. This also includes women who have been diagnosed with any of the above medical conditions but have had them surgically corrected.
  • A minimum of one cycle without treatment with fertility modifiers (e.g., oral contraceptives) during the last menstrual cycle before down regulation treatment
  • Willing to accept a maximum of two embryos transferred in the fresh cycle
  • Willing to use an adequate barrier method of contraception or refrain from intercourse from 2 weeks before start of down regulation and throughout the down regulation period

Who cannot join

  • 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
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  • 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
  • According to the judgment of the investigator, abnormal laboratory value of renal or hepatic function is clinically significant
  • Known current (3 months prior to screening) or past (1 year prior to screening) abuse of alcohol or drugs, and/or current or past smoking habit of more than 10 cigarettes per day
  • Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the trial with the exception of controlled thyroid function disease
  • Known history of chemotherapy (except for gestational conditions) or radiotherapy
  • According to the judgment of the investigator, abnormal laboratory value is clinically relevant
  • Use of any non-registered investigational drugs during 3 months before screening or previous participation in the study

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • Peking University First Hospital

    Beijing, Beijing Municipality

  • Peking University People's Hospital

    Beijing, Beijing Municipality

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan

  • Sun Yat-sen Memorial Hospital Sun Yat-sen University

    Guangzhou, Guangdong

  • The third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu

  • ShengJing Hospital of China Medical University

    Shenyang, Liaoning

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality

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

    Wuhan, Hubei

Other trials in China

About this study

Official title: 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 in Controlled Ovarian Stimulation in Chinese Females Undergoing an Assisted Reproductive Technology (ART) Program

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
Being tested
Highly Purified Urofollitropin, Recombinant Human Follitropin Alfa
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Highly Purified UrofollitropinDrug

    Also called Bravelle®

    for injection

  • Recombinant Human Follitropin AlfaDrug

    Also called Gonal-F®

    for injection

Study groups in NCT01922193
Study groupRoleWhat they receive
Test GroupExperimentalNot described
Receives: Drug: Highly Purified Urofollitropin
Control GroupActive comparatorNot described
Receives: Drug: Recombinant Human Follitropin Alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of retrieved oocytes per cycle

    Measured: About 36 hours post hCG (human chorionic gonadotrophin)

Secondary outcomes (12)

  1. The follicles development

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

  2. The fertilization rate

    Measured: 20h (± 1h) after insemination

  3. Implantation rate

    Measured: 5-6 weeks post embryo transfer

  4. Cycle cancellation rate

    Measured: 36 hours post hCG

  5. The positive serum β-hCG/hCG rate

    Measured: 13-15 days after embryo transfer

  6. The clinical pregnancy rate

    Regardless of fetal heart beat

    Measured: 5-6 weeks after embryo transfer

  7. The clinical pregnancy rate

    With fetal heart beat

    Measured: 5-6 weeks after embryo transfer

  8. The ongoing pregnancy rate

    Measured: 10-11 weeks after embryo transfer

  9. Total gonadotropin dose administered and the duration of gonadotropin treatment

    Measured: Up to day 16 (in the stimulation period)

  10. Serum E2 (Estradiol) concentrations

    Measured: On the day of hCG administration

  11. Frequency and severity of adverse events

    Measured: Expected maximum of 7 months

  12. Frequency and severity of injection site reactions

    Injection site reactions (in terms of "redness", "pain", "itching", "swelling" and "bruising")

    Measured: Day 1 up to day 16 of the controlled ovarian stimulation period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionFeb 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
263 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01922193
Sponsor's protocol ID
000089
Status last verified
Jun 2015
First submitted
24 Jul 2013
Last updated
16 Jun 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Highly Purified Urofollitropin and Recombinant Human Follitropin Alfa in people with Infertility, run by Ferring Pharmaceuticals at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of retrieved oocytes per cycle (time frame: About 36 hours post hCG (human chorionic gonadotrophin)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01922193.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.

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