Subfertility MedDRA version: 12. Level: LLT Classification code 10042391 Term: Subfertility
Conditions
Interventions
Trade Name: Pergoveris
Product Name: Pergoveris
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: follitropin alfa
Sponsors
NHS Lothian
The University of Edinburgh
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - healthy female; - aged 21 – 38 years; - undergoing IVF treatment for unexplained, tubal or male factor subfertility; - regular menstrual cycles (24-35 days); - both ovaries present (no previous surgery on ovaries); - able to understand protocol; - able to give informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - polycystic ovarian syndrome - endometriosis (severe) requiring treatment; - serum AMH level 155 mm Hg; diastolic >90mmHg); - history of alcohol or drug abuse; - abnormal biochemistry/haematology results at screening; - administration of investigational drugs within 20 days of Screening - not able to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to investigate whether controlled ovarian stimulation using Pergoveris with early administration of Cetrorelix (from day 2 of period, i.e. day 1 of gonadotrophin stimulation) versus administration of cetrorelix starting on day 6 of stimulation will result in more top quality embryos.; Secondary Objective: - Number and size of follicles on day of hCG. - Number and quality of oocytes and transferable embryos. - Endocrine profiles on day of hCG (LH, oestradiol, and progesterone). - Prevention of premature LH surge. - Total dose per cycle of r-FSH (Pergoveris). - Number of days of administration of Pergoveris. - Ovarian cyst formation; - Outcome of treatment cycle and pregnancy rate; - Rate of cycle cancellation due to under-response or over-response (serum E2, LH and folliculogram will be available for review) - Rate of poor ovarian response (defined as 4 or less oocytes retrieved) ;Primary end point(s): number of top quality embryos resulted from the treatment cycle | — |
Countries
United Kingdom
Outcome results
None listed