A mulitnational, multicenter, exploratory pharmacogenomics trial to test the importance of identified genetic markers, and potentially identify new markers of various ovarian responses to GONAL-f® treatment in women undergoing assisted reproduction technology (ART). - Pharmacogenomics trial of GONAL-f® in ART

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 1500

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 <30 kg/m2,
• Provided informed consent to enter the trial with the awareness that the genetic results of the trial will be kept anonymous, and that their medical specialist will not know their genetic results and thus, these will not influence their own future management.

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

• 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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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®.<br>• To analytically describe the four groups of women who had various ovarian responses to GONAL f®.<br>;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:<br> <br>Candidate genes: <br>> FSHR: rs6166 (p.N680S),<br>> BMP15: -673C/T, rs3810682 (-9C/G), rs3897937 (+905G/A), rs41308602 (p.N103S)<br>> ESR1: rs2234693 (938C/T)<br>> ESR2: rs4986938 (*39A/G)<br>> LHB: rs1800447 (p.W8R), rs3434826 (p.I15T)<br>> AMH: rs10407022 (p.I49S)<br>> AMHR2: rs2002555 ( 482A/G)<br>

Secondary Outcome Measures