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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT03208972 (opens ClinicalTrials.gov in a new tab)Other id2012-005676-34
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
107 participants (actual)
Sponsor
AZ Jan Palfijn Gent · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Belgium

Start
Oct 2014
Primary completion
Nov 2015
Completion
Nov 2015
First posted
6 Jul 2017
Last update posted
3 Feb 2021
Conditions
Infertility

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 4

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

    NCT03208972

    Oct 2014 to Nov 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • low dose hCGDrug
  • hp-FSHDrug
  • Corifollitropin AlfaDrug

Arms2

  • 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.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The financial costs of the stimulation in both groups

    Time frame · 1 year

Secondary outcomes(5)

  1. The number of MII oocytes obtained at the occasion of the oocyte retrieval

    Time frame · 3 weeks

  2. pregnancy rate

    Time frame · 5 weeks

  3. duration of the stimulation

    Time frame · one month

  4. hormonal levels reached at time of induction of final maturation of the oocyte

    Time frame · 3 weeks

  5. the number of clinical OHSS patients

    Time frame · one month

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 38 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * IVF/ICSI patients * Cycle 1, 2, 3, 4 Exclusion Criteria: * PCOS * Endocrinological diseases

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