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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03208972
• Other study ID #: 2012-005676-34
• Status: Completed
• Phase: Phase 4
• Start date: October 2014
• Est. completion date: November 2015

Study information

• Verified date: February 2021
• Source: AZ Jan Palfijn Gent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

Inclusion Criteria:

• IVF/ICSI patients

• Cycle 1, 2, 3, 4

Exclusion Criteria:

• PCOS

• Endocrinological diseases

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• low dose hCG

• hp-FSH

• 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

Locations

Country	Name	City	State
Belgium	AZ Jan Palfijn	Gent	Oost-Vlaanderen

Sponsors (2)

Lead Sponsor	Collaborator
AZ Jan Palfijn Gent	Onze Lieve Vrouw Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The financial costs of the stimulation in both groups		1 year
Secondary	The number of MII oocytes obtained at the occasion of the oocyte retrieval		3 weeks
Secondary	pregnancy rate		5 weeks
Secondary	duration of the stimulation		one month
Secondary	hormonal levels reached at time of induction of final maturation of the oocyte		3 weeks
Secondary	the number of clinical OHSS patients		one month