Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment

Study Overview
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Brief Summary
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The purpose of this study is to show equivalence with regard to the number of oocytes retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing IVF/ICSI

Official Title
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Multicentre Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment

Conditions
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Infertility, Female

Intervention / Treatment
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* Drug: Follitropin alfa (Gonal-f)
* Drug: Follitropin alfa (Primapur)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infertility due to tubal factor and/or male factor Age between 20 and 35 years with regular menstrual cycles of 21-35 days First or second cycle in the present series of ART BMI (body mass index) ≥ 18 ≤ 30 kg/m2 Basal FSH (follicle stimulating hormone) < 10 IU/L (cycle day 2-5) E2 (estradiol) levels < 50pg/mL (cycle day 2) AMH (anti-mullerian hormone) ≥ 1.0 ng/ml Antral follicle ≥ 4 to ≤ 15 follicles (both ovaries) Presence of both ovaries and normal uterine cavity Informed consent Exclusion Criteria: Presence of pregnancy Hypersensitivity to follitropin alfa Ovarian cysts History of ≥2 succeeding ART (assisted reproductive technology) cycles IVF (in vitro fertilization) and/or ICSI (Intracytoplasmic sperm injection) before the study cycle Previous history of severe ovarian hyperstimulation syndrome Presence of polycystic ovaries (PCO) Presence of endometriosis and hydrosalpinx Presence of uterine disorders History of poor (< 4 oocytes) or hyper (> 25 oocytes) responses to FSH treatment at dose 150 IU and GnRH-antagonist (gonadotropin-releasing hormone) protocol Premature ovarian failure Ectopic pregnancy (3 month before the study cycle) Presence of clinically significant systemic disease Presence of chronic cardiovascular, hepatic, renal or pulmonary disease Presence of endocrine disorder Neoplasia Male infertility without mobile spermatozoa in the ejaculate, that need MESA (Microsurgical epididymal sperm aspiration)/TESE (testicular sperm extraction)/TESA (testicular sperm aspiration) Smoking > 10 cigarettes/day Narcomania, alcoholism Planned PGS (preimplantation genetic screeneing) /PGD (preimplantation genetic diagnosis)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primapur (Follitropin alfa)<br> | Drug: Follitropin alfa (Primapur)<br>* Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation<br>|
| Active Comparator: Gonal-f (Follitropin alfa)<br> | Drug: Follitropin alfa (Gonal-f)<br>* Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oocytes (Intention-to-Treat, ITT) | The total number of retrieved oocytes at the day of ovum pick-up. No more than 37 hours from the introduction of the trigger of ovulation (hCG or GnRH-agonist). The equivalence in the number of retrieved oocytes was tested using a predetermined equivalence margin of +/- 3.4 oocytes. | From date of randomization up to 18 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Follicles With Size ≥ 16 mm | The number of follicles 16 mm or over in diameter at the day of hCG (or GnRH-agonist) administration | From date of randomization up to 16 days | 
| Mature Oocytes | The number of mature oocytes (MII stage of development) | From date of randomization up to 18 days | 
| Fertilised Oocytes | The number of fertilised oocytes with the presence of two pronuclei: 2PN | From date of randomization up to 19 days | 
| Percentage of Patients With Embryo Transfer | The number of patients (and percentage) with embryo transfers on days 3 and 5 after ovum pick-up | From date of randomization up to 25 days | 
| Total Dose of Follitropin Alfa | The total dose of the follitropin alfa administrated during the ovarian hyperstimulation protocol (measured in International Units - IU) | From date of randomization up to 16 days | 
| Number of Days of Follitropin Alfa Treatment | The duration of ovarian hyperstimulation protocol (at the day of trigger of ovulation) | From date of randomization up to 16 days | 
| Number of Patients With Follitropin Alfa Dose Correction | The number of dose adjustments during the ovarian hyperstimulation protocol (increment 25-50 IU) | From date of randomization up to 16 days | 
| Number of Patients With Cycle Cancellation | The number of the ovarian hyperstimulation protocol cancellation (at the day of trigger of ovulation) | From date of randomization up to 16 days | 
| Number of No-responders | The number of patients with no response to follitropin alfa treatment (absence of growing follicles, no any oocytes obtained at the day of ovum pick-up) | From date of randomization up to 8 days | 
| Percentage of Patients With Serum hCG More Than 25 IU/l | Biochemical pregnancy test: serum hCG more than 25 IU/l (days 12-17 after embryo transfer) | From date of randomization up to 42 days | 
| Percentage of Patients With the Evidence for Clinical Pregnancy | Confirmation of clinical pregnancy: ultrasound detection of intrauterine gestational sac and heart activity | The 10th week after embryo transfer | 

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