A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

Prospective open label, randomised, parallel group, comparative pilot.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Follicle Stimulating Hormone; Menotropins

Criteria

Female patients aged > or = 20 and < or = 35 years with a BMI of >18 and <32 kg/m2 who have received no more than two previous cycles of in vitro fertilisation (IVF) or other assisted reproductive technique (ART) and whose partners have normal sperm (according to WHO 1999 criteria).

Inclusion criteria:

• Signed informed consent;

• Subfertile premenopausal female patients eligible for IVF treatment;

• Aged >=20 and <=35 years;

• Body mass index of >18 and <32 kg/m2

• Normal endocrine assessment within the last 6 months;

• Normal pelvic ultrasound (showing two ovaries, no ovarian abnormalities and normal uterus) within the last 6 months;

• Receipt of no more than two previous cycles of IVF (or other ART);

• At least 3 consecutive ovulatory menstrual cycles of 24-35 days, and documented evidence of ovulatory cycles within the previous 12 months;

• No fertility-modifying treatment within the 3 months prior to this treatment cycle;

• Infertility attributable to or in association with either tubal factor, or unexplained causes;

• Sperm of partner classed as normal according to WHO 1999 criteria within the year prior to beginning therapy;

• Negative serum beta-HCG pregnancy test prior to beginning therapy;

• Clinically normal baseline haematology, clinical chemistry, and urinalysis parameter values, negative serum HBsAg and HIV antibody tests;

• Screening endocrine test results (estradiol, LH, FSH, progesterone, prolactin, TSH) in early follicular phase within the normal limits for the clinical laboratory.

Exclusion criteria

• Presence of any clinically relevant systemic disease(e.g. insulin- dependent diabetes mellitus);

• A history of or current endocrine disease, including polycystic ovary- like syndrome and hyperprolactinaemia;

• A history of coagulation disorders;

• Persistent ovarian cysts;

• Contraindications for the use of gonadotrophins or GnRH antagonists;

• A history of hypersensitivity to any of the constituents of the study medication or related compounds;

• Three or more previous cycles of IVF (or other ART);

• A history of alcohol abuse (more than 30 units per week on a regular basis);

• History of chemo- or radiotherapy;

• Currently breast-feeding, pregnant or with a contraindication to pregnancy;

• Diagnosed poor responders in prior IVF treatment;

• History of severe ovarian hyperstimulation syndrome (OHSS) (4 or 5) in former IVF treatment;

• Investigational drug within the 30 days prior to treatment;

• Any other condition or history that the investigator considers might increase the risk to the individual.