NCT03506243

Brief Summary

This study is for evaluating safety and efficacy of Recombinant human follicle-stimulating hormone (Follitrope) injection compared with Gonal-F® Pen undergoing controlled ovarian hyper stimulation in vitro fertilization - embryo transfer (IVF-ET) in China

Trial Health

87
On Track

Trial Health Score

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

Enrollment
451

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

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

April 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 24, 2018

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

1.4 years

First QC Date

April 11, 2018

Last Update Submit

April 22, 2018

Conditions

Infertility, Female

Keywords

IVF, rhFSH

Outcome Measures

Primary Outcomes (1)

  • The total number of oocytes retrieved

    The total number of oocytes retrieved

    15 days after using FSH

Secondary Outcomes (5)

  • Total dose and duration of FSH administration

    Throughout the study completion (e.g., 10 days)

  • No. of follicles with diameter equal or more than 14 mm on hGH injection day

    The day of hGH injection

  • No. of embryo transferred

    3 days after the ovum pick-up

  • Clinical pregnancy rate

    5 weeks after the embryo transfer

  • On-going pregnancy rate

    10 weeks after the embryo transfer

Study Arms (2)

Test group

EXPERIMENTAL

Follitrope PFS

Biological: Follitrope PFS

Control group

ACTIVE COMPARATOR

Gonal-F pen

Biological: Gonal-f pen

Interventions

Follitrope PFSBIOLOGICAL

Follitrope PFS

Test group
Gonal-f penBIOLOGICAL

Gonal-f pen

Control group

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Infertile adult women between 20 and 39 years at screening.
  • Infertile adult women with regular menstrual cycles of 25 to 35 days at screening.
  • Normal basal serum FSH, LH, E2, and P levels at the early follicular phase at screening.
  • If the cause of infertility is due to following reasons:
  • Tubal factor
  • Unknown reason
  • Male infertility
  • Combined factors
  • Willing to give voluntary written informed consent.

You may not qualify if:

  • Patients with a clinically significant systemic disease, endocrine or metabolic abnormalities.
  • Body Mass Index \> 30 (BMI; kg/m2) at screening.
  • Patients with a uterine (fibroids (diameter greater than or equal to 2CM endometrium), endometrial polyps, intrauterine adhesions, uterine malformations), ovaries (polycystic ovary, ovarian cysts) or adnexa (hydrosalpinx) abnormalities at screening.
  • patients with uterine, ovarian surgery treatment
  • Patients who experienced of severe ovarian hyperstimulation symptoms (OHSS) in previous IVF cycles.
  • Patients who have shown poor response with gonadotropin hormone therapy.
  • \*At least two of the following three features must be present:
  • ① A previous POR(≤3 retrieved oocyte with a conventional stimulation protocol)
  • ② An abnormal ovarian reserve test (i.e. AFC \< 5 follicles) at screening.
  • Abnormal metrorrhagia due to unknown reason at screening.
  • At least one of husband and wife to accept donor sperm or donor eggs or PGD subject
  • Subjects who are positive for HIV or syphilis at screening.
  • Significant known psychiatric disorder or who unable to understand the objectives and methods, etc. of this clinical trial and unable to comply with the study procedures at screening.
  • Presence of elicit alcohol, smoke or drug abuse habit at screening.
  • History of hypersensitivity to rhFSH or other pharmaceutical excipients of this drug.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangzhou Yuyuan Bioscience Technology Co.,Ltd

Hangzhou, Zhejiang, 310018, China

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Ying Pu Sun

    The First Affiliated Hospital of Zhengzhou University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2018

First Posted

April 24, 2018

Study Start

April 1, 2015

Primary Completion

September 1, 2016

Study Completion

May 1, 2017

Last Updated

April 24, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)