Clinical trial NCT01312766: Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients
Official title: Safety and Efficacy Study Comparing a New hMG Formulation (hMG-IBSA) to a Reference Product (Menopur®) in Patients Undergoing Ovarian Stimulation for in Vitro Fertilisation (IVF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Lead sponsor: IBSA Institut Biochimique SA
Sponsor class: INDUSTRY
First posted: 2011-03-11
Enrollment: 270
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Total Number of Oocytes Retrieved
timeFrame: up to 24 days after treatment start
Secondary outcomes:
measure: Mean hMG Dose (Total);
timeFrame: up to 22 days after treatment start
measure: Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)
timeFrame: up to 28 days after treatment start
measure: Positive b-hCG Test
timeFrame: up to 5 weeks after treatment start
measure: Controlled Ovarian Stimulation Duration (Days)
timeFrame: up to 23 days after treatment start
measure: 17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;
timeFrame: up to 23 days after treatment start
measure: Implantation Rate
timeFrame: 10-11 weeks after embryo transfer
measure: Clinical Pregnancy Rate,
timeFrame: 10 - 11 weeks after embryo transfer
measure: Number of Mature (Grade III Metaphase II) Oocytes Retrieved.
timeFrame: at the end of the stimulation.
measure: Ratio Mature/Total Number of Oocytes Retrieved.
timeFrame: at the end of the stimulation.
measure: Total Number of Inseminated Oocytes (IVF and ICSI)
timeFrame: on the day of oocyte retrieval
measure: Number of Cleaved Embryos
timeFrame: two days after insemination
measure: Live Birth Rate
timeFrame: 9 months after treatment
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Fertility clinic at Hvidovre Hospital
state: Copenhagen
city: Odense
country: Denmark
facility: Odense Universitetshospital
state: Odensee C
city: Paris
country: France
facility: Groupe Hospitalier Cochin - Saint Vincent de Paul
city: Budapest
country: Hungary
facility: First Dept. Obstetric and Gynaecology, Semmelweiss University
city: Basel
country: Switzerland
facility: Universitätsspital Basel
state: BS
city: Aldridge
country: United Kingdom
facility: Midland Fertility Services
state: West Midlands
Study officials:
affiliation: Hopital Cochin
name: Dominique De Ziegler, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: