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

Infertility Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312766
• Other study ID #: 10EU/hMG02
• Secondary ID: 2010-021021-13
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2011
• Last updated: July 23, 2015
• Start date: February 2011
• Est. completion date: December 2013

Study information

• Verified date: July 2015
• Source: IBSA Institut Biochimique SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: Medicines and Healthcare Products Regulatory AgencyDenmark: Danish Medicines AgencyHungary: National Institute of PharmacySwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: December 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Menotropins
Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
• Menotropins
Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.

Locations

Country	Name	City	State
Denmark	Fertility clinic at Hvidovre Hospital	Hvidovre	Copenhagen
Denmark	Odense Universitetshospital	Odense	Odensee C
France	Groupe Hospitalier Cochin - Saint Vincent de Paul	Paris
Hungary	First Dept. Obstetric and Gynaecology, Semmelweiss University	Budapest
Switzerland	Universitätsspital Basel	Basel	BS
United Kingdom	Midland Fertility Services	Aldridge	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
IBSA Institut Biochimique SA

Countries where clinical trial is conducted

Denmark,  France,  Hungary,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Number of Oocytes Retrieved		up to 24 days after treatment start	No
Secondary	Mean hMG Dose (Total);		up to 22 days after treatment start	No
Secondary	Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)	Assessed by counting the total number of embryos obtained, the number of embryos transferred, frozen and discarded.	up to 28 days after treatment start	No
Secondary	Positive b-hCG Test		up to 5 weeks after treatment start	No
Secondary	Controlled Ovarian Stimulation Duration (Days)		up to 23 days after treatment start	No
Secondary	17-ß Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;		up to 23 days after treatment start	No
Secondary	Implantation Rate	defined as the mean of the total number of implanted embryos (presence of gestational sac assessed by ultrasound) divided by the total number of transferred embryos x 100;	10-11 weeks after embryo transfer	No
Secondary	Clinical Pregnancy Rate,	defined as a pregnancy showing ultrasound embryonic heart activity at 10 - 11 weeks after embryo transfer;	10 - 11 weeks after embryo transfer	No
Secondary	Number of Mature (Grade III Metaphase II) Oocytes Retrieved.		at the end of the stimulation.	No
Secondary	Ratio Mature/Total Number of Oocytes Retrieved.	the percentage of mature oocytes in the total number of oocytes retrieved.	at the end of the stimulation.	No
Secondary	Total Number of Inseminated Oocytes (IVF and ICSI)	number of oocytes that were inseminated via IVF or injected via ICSI technique.	on the day of oocyte retrieval	No
Secondary	Number of Cleaved Embryos		two days after insemination	No
Secondary	Live Birth Rate		9 months after treatment	No