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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-08

Study Completion Date

2018-08-17

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

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Detailed Description

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Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Primapur (Follitropin alfa)

Group Type EXPERIMENTAL

Follitropin alfa (Primapur)

Intervention Type DRUG

Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation

Gonal-f (Follitropin alfa)

Group Type ACTIVE_COMPARATOR

Follitropin alfa (Gonal-f)

Intervention Type DRUG

Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation

Interventions

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Follitropin alfa (Gonal-f)

Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation

Intervention Type DRUG

Follitropin alfa (Primapur)

Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation

Intervention Type DRUG

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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No