Elonva in Combination With Hp-FSH Versus Elonva With Low Dose hCG

February 1, 2021 updated by: Dr. Decleer Wim, AZ Jan Palfijn Gent

Prospective Randomized Trial Comparing Ovarian Stimulation in IVF-patients With Corifollitropin Alfa in Combination With Hp-FSH Versus Corifollitropin Alfa in Combination With Low Dose hCG

The study compares in a randomized controlled way two stimulation methods. One of these stimulation methods implements a new insight in ovarian follicular growth. If this novel method of stimulation proves to be as efficient as the classical stimulation protocols, there might be a dramatic reduction of the costs of the medical therapy in IVF, thus reducing also the overall IVf costs significantly.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • AZ Jan Palfijn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • IVF/ICSI patients
  • Cycle 1, 2, 3, 4

Exclusion Criteria:

  • PCOS
  • Endocrinological diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low dose hCG (Pregnyl)
Corifollitropin Alfa (Elonva) dosage depending on weight once administered first day of ovarian stimulation in combination 150IU low dose hCG from day 7 until final oocyte maturation.
Drug: low dose hCG
Other Names:
  • Pregnyl
Drug: Corifollitropin Alfa

Corifollitropin Alfa (Elonva) dosage depending on weight, once administered first day of ovarian stimulation for all subjects, and on day 7 they proceed with the treatment of the allocated group.

<60 kg: Elonva 100 MCG > 60 kg: Elonva 150 MCG

Other Names:
  • Elonva
Active Comparator: hp-FSH (Menopur)
Corifollitropin Alfa (Elonva) dosage depending on weight once administered first day of ovarian stimulation in combination with hp-FSH until final oocyte maturation.
Drug: Corifollitropin Alfa

Corifollitropin Alfa (Elonva) dosage depending on weight, once administered first day of ovarian stimulation for all subjects, and on day 7 they proceed with the treatment of the allocated group.

<60 kg: Elonva 100 MCG > 60 kg: Elonva 150 MCG

Other Names:
  • Elonva
Drug: hp-FSH
Other Names:
  • Menopur

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The financial costs of the stimulation in both groups
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
pregnancy rate
Time Frame: 5 weeks
5 weeks
The number of MII oocytes obtained at the occasion of the oocyte retrieval
Time Frame: 3 weeks
3 weeks
duration of the stimulation
Time Frame: one month
one month
hormonal levels reached at time of induction of final maturation of the oocyte
Time Frame: 3 weeks
3 weeks
the number of clinical OHSS patients
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AZ Jan Palfijn Gent

Collaborators

Onze Lieve Vrouw Hospital

Investigators

  • Principal Investigator: Wim Decleer, MD, FERTILITY CENTER AZ JAN PALFIJN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

May 7, 2014

First Submitted That Met QC Criteria

July 3, 2017

First Posted (Actual)

July 6, 2017

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-005676-34

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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