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

NCT03208972 | Completed Phase 4

• 1 other identifier: 2012-005676-34
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

IVF; ovarian stimulation; low dose hCG; hp-FSH; Corifollitropin Alfa; costs of IVF

Outcome Measures

Primary Outcomes (1)

• The financial costs of the stimulation in both groups

  1 year

Secondary Outcomes (5)

• The number of MII oocytes obtained at the occasion of the oocyte retrieval

  3 weeks

• pregnancy rate

  5 weeks

• duration of the stimulation

  one month

• hormonal levels reached at time of induction of final maturation of the oocyte

  3 weeks

• the number of clinical OHSS patients

  one month

Study Arms (2)

low dose hCG (Pregnyl)

EXPERIMENTAL

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.

Drug: low dose hCG; Drug: Corifollitropin Alfa

hp-FSH (Menopur)

ACTIVE COMPARATOR

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

Drug: hp-FSH; Drug: Corifollitropin Alfa

Interventions

low dose hCG DRUG

Also known as: Pregnyl

low dose hCG (Pregnyl)

hp-FSH DRUG

Also known as: Menopur

hp-FSH (Menopur)

Corifollitropin Alfa 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

Also known as: Elonva

hp-FSH (Menopur); low dose hCG (Pregnyl)

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• PCOS
• Endocrinological diseases

Sponsors & Collaborators

• AZ Jan Palfijn Gent: lead
• Onze Lieve Vrouw Hospital: collaborator

Study Sites (1)

AZ Jan Palfijn

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Infertility

Interventions

Chorionic Gonadotropin; Menotropins; follicle stimulating hormone, human, with HCG C-terminal peptide

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins; Gonadotropins, Pituitary; Pituitary Hormones, Anterior; Pituitary Hormones; Biological Products; Complex Mixtures

Study Officials

• Wim Decleer, MD

  FERTILITY CENTER AZ JAN PALFIJN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: July 6, 2017
• Study Start: October 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

BE (1)