NCT01107470

Brief Summary

Age-related variability of the efficacy and tolerability of alternative pituitary suppression regimens in follicular stimulation for assisted reproduction purposes. A randomised, prospective, multi-centre clinical trial

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

March 26, 2012

Status Verified

April 1, 2010

Enrollment Period

3 years

First QC Date

April 20, 2010

Last Update Submit

March 22, 2012

Conditions

Keywords

Infertility IVF ART

Study Arms (4)

Group A1

Age 18-34y (with short protocol)

Drug: hFSH(Fostimon)

Group A2

age 35-42y ( with short protocol)

Drug: hFSH(Fostimon)

Group B1

age 18-34y ( with long protocol)

Drug: hFSH(Fostimon)

Group B2

age 35-42y ( with long protocol)

Drug: hFSH(Fostimon)

Interventions

After down-regulation (short protocol), all patients will be stimulated with hFSH (human-derived FSH).

Group A1

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients addressed to follicular stimulation for in vitro fertilisation purposes will constitute the study population.

You may qualify if:

  • Age 18 to 42
  • First IVF attempt
  • BMI 18 to 25
  • Basal FSH less than 12 for subjects below the age of 35 or less than 15 for subjects aged more than 35
  • Informed consent

You may not qualify if:

  • Genital malformation
  • Hypersensitivity to study drugs
  • Major illnesses (to be specified)
  • PCOS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong University reproductive medicine researche center

Jinan, Shandong, 250000, China

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Zijiang Chen, Professor

    Director of Shandong University reproductive medicine study center

    STUDY DIRECTOR

Central Study Contacts

Zijiang Chen, professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 20, 2010

First Posted

April 21, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

March 26, 2012

Record last verified: 2010-04

Locations