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

AZ Jan Palfijn Gent

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: hp-FSH; Drug: low dose hCG; Drug: Corifollitropin Alfa

Study type: Interventional

Funder types: Other

Identifiers

NCT03208972

2012-005676-34

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• PCOS
• Endocrinological diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

low dose hCG (Pregnyl)

Experimental group

Description:

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.

Treatment:

Drug: low dose hCG

Drug: Corifollitropin Alfa

hp-FSH (Menopur)

Active Comparator group

Description:

Corifollitropin Alfa (Elonva) dosage depending on weight once administered first day of ovarian stimulation in combination with hp-FSH until final oocyte maturation.

Treatment:

Drug: Corifollitropin Alfa

Drug: hp-FSH