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

Primary Purpose

Infertility

Status

Completed

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

low dose hCG

hp-FSH

Corifollitropin Alfa

About this trial

This is an interventional treatment trial for Infertility focused on measuring IVF, ovarian stimulation, low dose hCG, hp-FSH, Corifollitropin Alfa, costs of IVF

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

PCOS
Endocrinological diseases

Sites / Locations

AZ Jan Palfijn

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

low dose hCG (Pregnyl)

hp-FSH (Menopur)

Arm 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.

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

Outcomes

Primary Outcome Measures

The financial costs of the stimulation in both groups

Secondary Outcome Measures

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

pregnancy rate

duration of the stimulation

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

the number of clinical OHSS patients

Full Information

NCT ID

NCT03208972

First Posted

May 7, 2014

Last Updated

February 1, 2021

Sponsor

AZ Jan Palfijn Gent

Collaborators

Onze Lieve Vrouw Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03208972

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

AZ Jan Palfijn Gent

Collaborators

Onze Lieve Vrouw Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

107 (Actual)

8. Arms, Groups, and Interventions

Arm Title

low dose hCG (Pregnyl)

Arm Type

Experimental

Arm 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.

Arm Title

hp-FSH (Menopur)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

low dose hCG

Other Intervention Name(s)

Pregnyl

Intervention Type

Drug

Intervention Name(s)

hp-FSH

Other Intervention Name(s)

Menopur

Intervention Type

Drug

Intervention Name(s)

Corifollitropin Alfa

Other Intervention Name(s)

Elonva

Intervention Description

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

Primary Outcome Measure Information:

Title

The financial costs of the stimulation in both groups

Time Frame

1 year

Secondary Outcome Measure Information:

Title

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

Time Frame

3 weeks

Title

pregnancy rate

Time Frame

5 weeks

Title

duration of the stimulation

Time Frame

one month

Title

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

Time Frame

3 weeks

Title

the number of clinical OHSS patients

Time Frame

one month

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: IVF/ICSI patients Cycle 1, 2, 3, 4 Exclusion Criteria: PCOS Endocrinological diseases

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wim Decleer, MD

Organizational Affiliation

FERTILITY CENTER AZ JAN PALFIJN

Official's Role

Principal Investigator

Facility Information:

Facility Name

AZ Jan Palfijn

City

Gent

State/Province

Oost-Vlaanderen

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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