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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Infertility

Intervention / Treatment
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* Drug: low dose hCG
* Drug: hp-FSH
* Drug: Corifollitropin Alfa


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low dose hCG (Pregnyl)<br>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<br> <br> * Other names: Pregnyl;Drug: Corifollitropin Alfa<br>* 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<br>* Other names: Elonva;|
| Active Comparator: hp-FSH (Menopur)<br>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<br> <br> * Other names: Menopur;Drug: Corifollitropin Alfa<br>* 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<br>* Other names: Elonva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The financial costs of the stimulation in both groups |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, ovarian stimulation, low dose hCG, hp-FSH, Corifollitropin Alfa, costs of IVF