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

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: low dose hCG; Drug: hp-FSH; Drug: Corifollitropin Alfa

• Registration Number: NCT03208972
• Lead Sponsor: AZ Jan Palfijn Gent

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2014-05-07
• Study Start: 2014-10
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-06
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 107

Inclusion Criteria

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

Exclusion Criteria

• PCOS
• Endocrinological diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low dose hCG (Pregnyl)	low dose hCG	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.
hp-FSH (Menopur)	hp-FSH	Corifollitropin Alfa (Elonva) dosage depending on weight once administered first day of ovarian stimulation in combination with hp-FSH until final oocyte maturation.
low dose hCG (Pregnyl)	Corifollitropin Alfa	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.
hp-FSH (Menopur)	Corifollitropin Alfa	Corifollitropin Alfa (Elonva) dosage depending on weight once administered first day of ovarian stimulation in combination with hp-FSH until final oocyte maturation.

Primary Outcome Measures

Name	Time	Method
The financial costs of the stimulation in both groups	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AZ Jan Palfijn; 🇧🇪 Gent, Oost-Vlaanderen, Belgium