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

NCT ID: NCT03208972

Last Updated: 2021-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

low dose hCG

Intervention Type DRUG

Corifollitropin Alfa

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

hp-FSH

Intervention Type DRUG

Corifollitropin Alfa

Intervention Type DRUG

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

Interventions

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low dose hCG

Intervention Type DRUG

hp-FSH

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Pregnyl Menopur Elonva

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* PCOS
* Endocrinological diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Onze Lieve Vrouw Hospital

OTHER

Sponsor Role collaborator

AZ Jan Palfijn Gent

OTHER

Sponsor Role lead

Responsible Party

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Dr. Decleer Wim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wim Decleer, MD

Role: PRINCIPAL_INVESTIGATOR

FERTILITY CENTER AZ JAN PALFIJN

Locations

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AZ Jan Palfijn

Ghent, Oost-Vlaanderen, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2012-005676-34

Identifier Type: -

Identifier Source: org_study_id

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