A Phase 2, Trial to Investigate the Dose-Response Relationship of a Single Injection of Org 36286 (Corifollitropin Alfa) to Initiate Multiple Follicular Growth in a Controlled Ovarian (Study 38826)(P06055)(COMPLETED)

Study Overview
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Brief Summary
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The primary objective of this trial is to investigate the dose -response relationship of a single injection of Org 38286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol for IVF or ICSI.

Official Title
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A Phase 2, Open Label, Randomized Trial to Investigate the Dose-Response Relationship of a Single Injection of Org 36286 (Corifollitropin Alfa) to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or ICSI.

Conditions
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Fertilization

Intervention / Treatment
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* Drug: corifollitropin alfa
* Drug: Follitropin beta injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females of couples with an indication for COH and IVF or ICSI; >=18 and <=39 years of age at the time of signing informed consent; BMI >=18 and <=29 kg/m^2; Normal menstrual cycle length: 24-35 days; Ejaculatory sperm (use of donated and/or frozen sperm is allowed); Willing and able to sign informed consent. Exclusion Criteria: History of/or any current (treated) endocrine abnormality; History of ovarian hyperstimulation syndrome (OHSS); History of/or current polycystic ovary syndrome (PCOS) or current polycystic ovaries according to USS (at least 10 follicles of 2-8 mm in each ovary); More than three unsuccessful COH cycles since the last established ongoing pregnancy (if applicable); History of non- or low ovarian response to FSH/hMG treatment; Any clinically relevant hormone value outside the reference range during the early follicular phase (menstrual cycle day 2-7) as measured by the local laboratory (FSH, LH, E2, P, total T, TSH and prolactin): Any clinically relevant abnormal laboratory value; Less than 2 ovaries; Any ovarian and/or abdominal abnormality interfering with ultrasound examination; Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts); Epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease; History of presence of alcohol or drug abuse within 12 months prior to signing informed consent; Previous use of Org 36286; Use of hormonal preparations within 1 month prior to randomization; Hypersensitivity to Org 32489 (Puregon®) and/or Org 37462 (Orgalutran®) and/or Pregnyl® or any of their components; Administration of investigational drugs within three months prior to signing informed consent.

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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No

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: 1<br>60 µg Org 36286 (corifollitropin alfa) | Drug: corifollitropin alfa<br>* On Cycle Day 2, a single injection of 60 μg, 120 μg, or 180 μg Org 36286 was administered. One week later (Treatment Day 8), treatment was continued with a fixed daily subcutaneous (SC) dose of 150 IU Puregon® up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and up to and including the Day of hCG. The maximum total treatment duration was 19 days.<br>* Other names: Org 36286;|
| Experimental: 2<br>120 µg Org 36286 (corifollitropin alfa) | Drug: corifollitropin alfa<br>* On Cycle Day 2, a single injection of 60 μg, 120 μg, or 180 μg Org 36286 was administered. One week later (Treatment Day 8), treatment was continued with a fixed daily subcutaneous (SC) dose of 150 IU Puregon® up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and up to and including the Day of hCG. The maximum total treatment duration was 19 days.<br>* Other names: Org 36286;|
| Experimental: 3<br>180 µg Org 36286 (corifollitropin alfa) | Drug: corifollitropin alfa<br>* On Cycle Day 2, a single injection of 60 μg, 120 μg, or 180 μg Org 36286 was administered. One week later (Treatment Day 8), treatment was continued with a fixed daily subcutaneous (SC) dose of 150 IU Puregon® up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and up to and including the Day of hCG. The maximum total treatment duration was 19 days.<br>* Other names: Org 36286;|
| Active Comparator: 4<br>Follitropin beta injection | Drug: Follitropin beta injection<br>* Starting on Cycle Day 2, a fixed daily dose of 150 IU Puregon® SC was administered for the entire stimulation period up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and given up to and including the day of hCG. The maximum total treatment duration was 19 days.<br>* Other names: Puregon®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cumulus-oocyte-complexes retrieved |  | 1 cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure rate |  | 1 cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In-vitro fertilization