Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-12-31

Brief Summary

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The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations when administered to patients undergoing controlled ovarian stimulation for IVF.

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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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hMG-IBSA

New hMG preparation.

Group Type EXPERIMENTAL

Menotropins

Intervention Type DRUG

Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.

Menopur

Group Type ACTIVE_COMPARATOR

Menotropins

Intervention Type DRUG

Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.

Interventions

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Menotropins

Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.

Intervention Type DRUG

Menotropins

Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women undergoing ovarian stimulation for IVF with the following characteristics:

* Able and willing to sign the Patient Consent Form and adhere to the study visitation schedule
* \>18 and \<40 years old
* BMI between 18 and 30 kg/m2
* less than 3 previously completed IVF cycles (i.e. completed cycle = egg recovery)
* basal FSH \<10 IU/L and E2 \<80 pg/ml (\~290 pmol/l)
* Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or hysteroscopic examination
* Successful down-regulation performed with a standard GnRH-Agonist long protocol (Criteria for successful down-regulation: endometrial thickness \< 7mm or serum E2 level \<50 pg/ml (\~185 pmol/l).

Exclusion Criteria

* age \<18 and \>40 years
* primary ovarian failure or women known as poor responders (i.e. requiring more than 225 IU of hMG as a starting dose in previous treatment cycles or having less than 3 oocytes retrieved, or with a pre-ovulatory E2 serum concentration \<500pg/ml (\~1800 pmol/l))
* PCOS
* one or both ovaries inaccessible for oocyte retrieval
* ovarian cysts \>10 mm
* hydrosalpinx that have not been surgically removed or ligated;
* stage 3 or 4 endometriosis
* oocyte donation
* implantation of previously frozen embryos
* patients affected by pathologies associated with any contraindication of being pregnant
* hypersensitivity to the study medication
* abnormal bleeding of undetermined origin
* uncontrolled thyroid or adrenal dysfunction
* neoplasias
* severe impairment of renal and/or hepatic function
* use of concomitant medications that might interfere with study evaluations (e.g. non-study hormonal medications, prostaglandin inhibitors, psychotropic agents)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No