A phase IV prospective, multicentre, randomized, open-label trial to assess the efficacy and safety of GONAL f® at a dose based on subject baseline characteristics determined according to the CONSORT calculator compared with a standard dose of GONAL f® 150 IU per day for ovarian stimulation in women undergoing assisted reproductive technology (ART)

Phase 4

Completed

• Conditions: infertility; fertillity problem; 10013356

• Registration Number: NL-OMON32275
• Lead Sponsor: Serono

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Be a female subject justifying an IVF/ET treatment,
Be between her 18th and 35th birthday (35 not included) at the time of the randomisation visit,
A body mass index (BMI) < 30 kg/m2 where the BMI is calculated
Have early follicular phase (day 2-4) serum level of basal FSH £ 12 IU/L measured in the centre*s local laboratory during the screening period (i.e. within 2 months prior to down regulation start),

Exclusion Criteria

Had >= 2 previous ART cycles with a poor response to gonadotrophin stimulation (defined as < 5 mature follicles and/or < 3 oocytes collected) or had >= 2 previous ART cycles with a hyper response (defined as ³ 25 oocytes retrieved),

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy endpoint will be measured by the total number of oocytes<br /><br>retrieved per subject following GONAL f® stimulation and human chorionic<br /><br>gonadotrophin (r hCG (Ovidrel®/Ovitrelle®) injection in both treatment arms.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary efficacy endpoints will be measured in both treatment arms by:<br /><br>total dose of GONAL f® used (in IU), mean daily dose of GONAL f® (in IU), total<br /><br>number of GONAL f® stimulation treatment days, cycle cancellation for excessive<br /><br>or inadequate response to GONAL f®, number of biochemical pregnancies (by serum<br /><br>b hCG level), Number of foetal sacs and foetal hearts with activity as seen on<br /><br>an US scan on Day 35-42 post r hCG (to confirm clinical pregnancy),<br /><br>implantation rate (sacs with heartbeat per total number of embryos<br /><br>transferred), total and clinical pregnancy rate per subject (per cycle started,<br /><br>and per ET), multiple pregnancy, levels of serum AMH (central laboratory<br /><br>analysis),serum levels of progesterone (central laboratory analysis), genetic<br /><br>variations associated with response to treatment.</p><br>