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

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ClinicalTrials.gov Identifier: NCT03208972
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Collaborator:
Onze Lieve Vrouw Hospital
Information provided by (Responsible Party):
Dr. Decleer Wim, AZ Jan Palfijn Gent

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: low dose hCG Drug: hp-FSH Drug: Corifollitropin Alfa Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
Experimental: low dose hCG (Pregnyl)
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
Other Name: Pregnyl

Drug: 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

Other Name: Elonva

Active Comparator: hp-FSH (Menopur)
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
Other Name: Menopur

Drug: 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

Other Name: Elonva




Primary Outcome Measures :
  1. The financial costs of the stimulation in both groups [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. The number of MII oocytes obtained at the occasion of the oocyte retrieval [ Time Frame: 3 weeks ]
  2. pregnancy rate [ Time Frame: 5 weeks ]
  3. duration of the stimulation [ Time Frame: one month ]
  4. hormonal levels reached at time of induction of final maturation of the oocyte [ Time Frame: 3 weeks ]
  5. the number of clinical OHSS patients [ Time Frame: one month ]


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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • PCOS
  • Endocrinological diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208972


Locations
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Belgium
AZ Jan Palfijn
Gent, Oost-Vlaanderen, Belgium, 9000
Sponsors and Collaborators
AZ Jan Palfijn Gent
Onze Lieve Vrouw Hospital
Investigators
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Principal Investigator: Wim Decleer, MD FERTILITY CENTER AZ JAN PALFIJN
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Responsible Party: Dr. Decleer Wim, MD, AZ Jan Palfijn Gent
ClinicalTrials.gov Identifier: NCT03208972    
Other Study ID Numbers: 2012-005676-34
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Keywords provided by Dr. Decleer Wim, AZ Jan Palfijn Gent:
IVF
ovarian stimulation
low dose hCG
hp-FSH
Corifollitropin Alfa
costs of IVF
Additional relevant MeSH terms:
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Infertility
Chorionic Gonadotropin
Menotropins
Reproductive Control Agents
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents