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CompletedNCT02335879Updated Jan 12, 2015

Phase III Clinical Study of Domestic Recombinant Human Follitropin for Injection to Treat WHO Class II Anovulation

A Phase 3 interventional study of Gonal-F in Anovulation, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. Completed. Open to female participants aged 21 Years to 38 Years. Per ClinicalTrials.gov, last updated 2015-01-12.

Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
534
Allocation
Not applicable
Ages
21 Years to 38 Years
Sex
Female
01

Study summary

The purpose of this study is to evaluate the efficacy and safety of Domestic Recombinant Human Follitropin (Gonal-F) for Injection for treatment of WHO Ⅱ anovulation (including polycystic ovarian syndrome [PCOS] subjects).

02

Conditions studied

  • Anovulation

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03

In context

Anovulation

75 studies on the registry are indexed under Anovulation; 7 are open to participants now.

This study's enrollment of 534 is above the median of 80 across 52 interventional studies indexed under Anovulation.

Browse Anovulation studies →

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd. is the lead sponsor of 111 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 38 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Married infertile women at the age of 21-38.
  • \<28kg/m2.
  • According to the detection level of serum estradiol (E2), prolactin (PRL), progesterone (P), testosterone (T), luteinizing hormone (LH), follicle stimulating hormone (FSH), subjects were diagnosed of WHO class II anovulation or oligo-ovulation, and the above hormone level of the subject is normal or normal after treatment at the beginning of study, and FSH\<10IU/L.
  • Bilateral fallopian tubes are unobstructed proved by hysterosalpingograph or laparoscopic examination within one year, no history of abortion or pelvic infection after the examination, the researcher decide whether the above examination need to repeat. If the subject had salpingoplasty under laparoscope, and the bilateral fallopian tubes are unobstructed after the surgery, there is no need to have the hysterosalpingograph. If it can not be confirmed, it must be done again to prove that the bilateral fallopian tubes are unobstructed.
  • Vaginal B-ultrasound examination shows that there is no ovarian pathological tumor, no hysteromyoma or hysteromyoma\<4cm, and does not affect the endometrial function.
  • Two examinations of spouse semen are normal within six months, or comply with the IUI standard.
  • No history of drug abuse.
  • Voluntarily sign the form and agree with medication and accepting evaluation according to the requirements of the research protocol.

Exclusion criteria

Exclusion Criteria:

  • The subject use gonadotropin therapy within the past three months (regardless the result of treatment).
  • The uterine factors affect pregnancy and other tumors.
  • Pregnancy , such as genetic diseases, mental diseases, drug abuse, sexually transmitted diseases, severe heart disease and hepatic and kidney function insufficiency.
  • Obscure vaginal bleeding.
  • Subjects are allergic to the application of FSH/HMG and HCG in the past.
  • Other conditions that the researchers think they are not suitable for the clinical trials.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
534 participants (actual)

Study arms

  • Experimental
    Recombinant Human Follitropin

    Biological: Gonal-F

Interventions

06

What researchers measure

Primary outcomes

  1. The efficiency reached mature follicle (the diameter of follicular ≥18mm by type-B ultrasonic) within the start period on the day of HCG day.

    Time frame: participants will be followed within the HCG day, an expected average of 14±2 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02335879
Collaborators
Peking University People's Hospital, Peking University First Hospital, Reproductive & Genetic Hospital of CITIC-Xiangya, Qilu Hospital of Shandong University, Wuhan Union Hospital, China, Second Hospital of Jilin University, Shengjing Hospital, The First Affiliated Hospital of Dalian Medical University, Second Affiliated Hospital of Wenzhou Medical University
Responsible party
Sponsor
First posted
Jan 12, 2015
Start date
May 2008
Primary completion
Aug 2009
Last update
Jan 12, 2015
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Follitropin alfa

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