Controlled ovarian stimulation in women with ovarian ageing PT: Assisted Fertilisation MedDRA version: 7.0 Level: PT Classification code 10003539
Conditions
Interventions
Trade Name: LUVERIS
Product Name: LUVERIS 75 UI
Product Code: Not Applicable
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Lutropin alfa
Other descriptive nam
Sponsors
SERONO ESPAÑA, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pre-menopausal woman, aged between 35 and 40 years of age inclusive, wishing to conceive. 2) Baseline (early follicular, day 2-5) FSH serum level £ 10 IU/l assessed within the past 6 months as well as LH and E2 levels within local normal range. 3) Having regular spontaneous menstrual cycle lasting 25-35 days. 4) Infertility justifying IVF/ET or ICSI treatment. 5) Controlled ovarian stimulation with r-hFSH under long GnRH agonist protocol. 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: 1) Known to be HIV, HBV/HCV positive. 2) Any clinically significant systemic disease; tumours of the hypothalamus and pituitary gland; ovarian, uterine or mammary cancer; hormonal abnormality and/or medical, biochemical, hematological condition which in the judgement of the investigator may interfere with gonadotropin treatment. 3) More than 2 previous ART cycles 4) Cancellation of two previous cycles. 5) Cryopreserved embryos from previous ART cycles
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of mid-follicular addition of r-hLH versus no addition of r-hLH, in patients aged between 35 and 40 undergoing controlled ovarian stimulation with r-hFSH priot to IVF / ICSI and ET, in terms of oocyte quality as well as follicular development, oocyte fertilization, embryo quality and pregnancy rates.;Secondary Objective: To assess the safety of using r-hLH in combination with r-hFSH in this indication, including incidence of ovarian hyperstimulation syndrome (OHSS) and adverse events as well as local tolerance;Primary end point(s): The proportion of metaphase II oocytes retrieved | — |
Countries
Spain
Outcome results
None listed