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
Sponsored by
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
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
No
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
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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