Overview

This trial is active, not recruiting.

Condition infertility
Treatments menotropins
Phase phase 3
Sponsor IBSA Institut Biochimique SA
Start date February 2011
End date April 2013
Trial size 272 participants
Trial identifier NCT01312766, 10EU/hMG02, 2010-021021-13

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
New hMG preparation.
menotropins
Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
(Active Comparator)
menotropins
Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.

Primary Outcomes

Measure
Total number of oocytes retrieved
time frame: up to 24 days after treatment start

Secondary Outcomes

Measure
Mean hMG dose (daily and total);
time frame: up to 22 days after treatement start
Oocyte quality
time frame: up to 24 days after treatement start
Embryo quality
time frame: up to 28 days after treatement start
Positive b-hCG test per oocyte retrieval and per embryo transfer;
time frame: up to 5 weeks after treatment start
Incidence of OHSS (according to Golan classification);
time frame: up to 5 weeks after treatment start
Number of days of hMG stimulation;
time frame: up to 22 days after treatment start
Number of follicles >16 mm on the day of hCG injection;
time frame: up to 23 days after treatment start
17-β estradiol (E2) serum concentration on the monitoring day before hCG injection;
time frame: up to 23 days after treatment start
Cancellation rate with reasons;
time frame: up to 23 days after treatment start
Implantation rate
time frame: 10-11 weeks after embryo transfer
Clinical pregnancy rate,
time frame: 10 - 11 weeks after embryo transfer
Adverse Events (AEs) (time of onset, severity, duration and action/treatment required);
time frame: up to 15 weeks after treatment start
Local tolerability at the injection site;
time frame: up to 23 days after treatment start
Overall assessment of health;
time frame: up to 23 days after treatment start

Eligibility Criteria

Female participants from 18 years up to 40 years old.

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)

Additional Information

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)
Principal investigator Dominique De Ziegler, MD, Prof
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by IBSA Institut Biochimique SA.