Comparison Between Recombinant Versus Urinary hCG for Ovulation Induction in High Responders

Study Overview
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Brief Summary
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The purpose of this study is to compare the clinical outcomes of recombinant human chorionic gonadotrophin (rHCG) and urinary HCG (uHCG) in patients undergoing IVF cycles.

Detailed Description
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Urinary human chorionic gonadotrophin (u-hCG) has been widely used to induce final oocyte maturation and to trigger ovulation in assisted conception. Recombinant technology has allowed the production of r-hCG inj which all urinary contaminants are absent. Hence, this would allow the safe subcutaneous administration of a compound with less batch-to-batch variation. This study will investigate the effectiveness of the recombinant hCG compared to the currently used urinary hCG.

Official Title
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Recombinant hCG (Ovitrelle) Vesrus Urinary hCG (Pregnyl) for Triggering Final Oocyte Maturation in High Responders

Conditions
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Infertility

Intervention / Treatment
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* Drug: rHCG 250ug
* Drug: uHCG 5000 IU
* Drug: uHCG 7500 IU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 14 follicles >11mm on the day of triggering final oocyte maturation Pretreated with GnRH antagonist protocol Exclusion Criteria: Poor responders Women with 25 or more follicles on the day of trigger

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 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 |
| --- | --- |
| Active Comparator: rHCG 250 ug<br>Injection of 250 ug Ovitrelle to trigger final oocyte maturation | Drug: rHCG 250ug<br>* Injection of 250 ug Ovitrelle to trigger final oocyte maturation<br>* Other names: Ovitrelle;|
| Active Comparator: uHCG 5000 IU<br>Injection of 5000 IU Pregnyl to trigger final oocyte maturation | Drug: uHCG 5000 IU<br>* Injection of 5000 IU Pregnyl to trigger final oocyte maturation<br>* Other names: Pregnyl 5000 IU;|
| Active Comparator: uHCG 7500 IU<br>Injection of 7500 IU Pregnyl to trigger final oocyte maturation | Drug: uHCG 7500 IU<br>* Injection of 7500 IU Pregnyl to trigger final oocyte maturation<br>* Other names: Pregnyl 7500 IU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of mature oocytes | Percentage MII/COCs | Day of oocyte retrieval (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive test per embryo transfer |  | 15 days post oocyte retrieval | 
| Clinical pregnancy per embryo transfer |  | 7 weeks of gestation | 
| Ongoing pregnancy per embryo transfer |  | 12 weeks of gestation | 
| Level of serum hCG on day of oocyte retrieval |  | Day of oocyte retrieval | 
| Number of oocytes (COC) retrieved |  | Day of oocyte retrieval | 
| Number of mature oocytes (MII) |  | Day of oocyte retrieval | 
| Oocyte retrieval rate | Number of oocytes retrieved/number of follicles on the day of triggering final oocyte maturation | Day of oocyte retrieval (Day 0) | 
| Incidence of severe early OHSS |  | up to Day 5 post oocyte retrieval | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recombinant hCG, urinary hCG