Females undergoing assisted reproductive technology (ART), in vitro fertilisation (IVF) or intra cytoplasmic sperm injection (ICSI) MedDRA version: 9.1 Level: LLT Classification code 10021930 Term: Infertility NOS
Conditions
Interventions
Trade Name: GONAL-f®
Product Name: GONAL-f®
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Follitropin alfa
Concentration unit: IU/ml international unit(s)/mil
Sponsors
Merck Serono International S.A., A branch of Laboratoires Serono S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Be between 30 and 39 years of age inclusive at the time of Informed Consent signature, • Have completed treatment with GONAL f® for an IVF or ICSI cycle within 6 months prior to informed consent signature (index cycle), • Have received a standard long GnRH agonist protocol (during the index cycle), • Both ovaries present, • Body mass index (BMI) =20 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Organic ovarian cysts >3cm during the index cycle including endometriomata, • Concomitant therapy to enhance GONAL-f® (steroids, growth hormone and LH except when LH has been used after Day 5, i.e. Day 6 or later, in subjects classified as suboptimal), • Major systemic disease (such as diabetes mellitus type 1 and 2), • Metformin therapy for infertility treatment within 2 months prior to or during GONAL-f® treatment (i.e., during the index cycle).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the relative importance of genetic markers identified in the literature predictive of ovarian response to GONAL f®. ;Secondary Objective: • To identify novel genetic markers predictive of ovarian response to GONAL f®. • To analytically describe the four groups of women who had various ovarian responses to GONAL f®. ;Primary end point(s): The primary endpoint for this trial is to determine the difference in the allele frequency of selected genetic markers between normal ovarian response and various responses (i.e., poor, suboptimal, OHSS) to GONAL f® stimulation. The specific genetic variations to be studied will include: Candidate genes: > FSHR: rs6166 (p.N680S), > BMP15: -673C/T, rs3810682 (-9C/G), rs3897937 (+905G/A), rs41308602 (p.N103S) > ESR1: rs2234693 (938C/T) > ESR2: rs4986938 (*39A/G) > LHB: rs1800447 (p.W8R), rs3434826 (p.I15T) > AMH: rs10407022 (p.I49S) > AMHR2: rs2002555 ( 482A/G) | — |
Countries
Austria, France, Spain, Sweden, United Kingdom
Outcome results
None listed