NCT02430740

Brief Summary

The study objective is to develop a tailored based strategy for ovarian stimulation in IVF patients using AMH, BMI, antral follicle count (AFC). 300 patients will be randomized in 2 arms:

  1. 1.control group: standard care rec FSH.
  2. 2.study group: modified dose of Rec FSH based on AFC with a correction factor based on BMI and basal AMH level.

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
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_4

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

First Submitted

Initial submission to the registry

April 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

7.9 years

First QC Date

April 27, 2015

Last Update Submit

April 11, 2023

Conditions

Infertility

Keywords

Fertilization in Vitroantagonist protocolantral follicle countAnti-Mullerian HormoneReproductive Techniques, Assisted

Outcome Measures

Primary Outcomes (3)

  • number of mature follicles

    2 years

  • number of oocytes retrieved

    2 years

  • rec FSH dose used

    2 years

Secondary Outcomes (5)

  • fertilization rate

    2 years

  • cleavage rate

    2 years

  • clinical pregnancy rate

    2 years

  • AMH level during stimulation

    2 years

  • Inhibin B level during stimulation

    2 years

Study Arms (2)

control group

OTHER

standard care recFSH

Drug: recFSH

study group

EXPERIMENTAL

modified dosage of recFSH for controlled ovarian stimulation based on AMH, BMI and AFC

Drug: recFSH

Interventions

recFSHDRUG
Also known as: Gonal F, Puregon, Fostimon
control groupstudy group

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • female infertile patients eligible for IVF treatment

You may not qualify if:

  • polycystic ovaries
  • untreated thyroid pathology
  • hypogonadotropic hypogonadism
  • untreaed hyperprolactinemia
  • study drug hypersensitivity
  • previous OHSS
  • unilateral ovariectomy
  • genital malformation
  • BMI\>40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

InfertilityHelping Behavior

Interventions

follitropin alfafollitropin beta

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesSocial BehaviorBehavior

Central Study Contacts

Christine Wyns, MD, PhD

CONTACT

003227649501christine.wyns@uclouvain.be

Céline Pirard, Md, PhD

CONTACT

003227644116celine.pirard@uclouvain.be

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 27, 2015

First Posted

April 30, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)