NCT02335879

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
534

participants targeted

Target at P75+ for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 12, 2015

Completed
Last Updated

January 12, 2015

Status Verified

January 1, 2015

Enrollment Period

1.3 years

First QC Date

January 5, 2015

Last Update Submit

January 9, 2015

Conditions

Anovulation

Outcome Measures

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.

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

Study Arms (1)

Recombinant Human Follitropin

EXPERIMENTAL
Biological: Gonal-F

Interventions

Gonal-FBIOLOGICAL
Recombinant Human Follitropin

Eligibility Criteria

Age21 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Married infertile women at the age of 21-38.
  • BMI\<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 informed consent form and agree with medication and accepting evaluation according to the requirements of the research protocol.

You may not qualify if:

  • The subject use gonadotropin therapy within the past three months (regardless the result of treatment).
  • The uterine factors affect pregnancy and other tumors.
  • Pregnancy contraindication, 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anovulation

Interventions

follitropin alfa

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2015

First Posted

January 12, 2015

Study Start

May 1, 2008

Primary Completion

August 1, 2009

Last Updated

January 12, 2015

Record last verified: 2015-01