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Effect of recombinant FSH dosing following corifollitropin alfa in IVF/ICSI with GnRH antagonist
2018-002000-13Phase 4
Key facts
- Status
- Active
- Start
- Nov 2018
- Countries
- 1
- Sponsor
- UZ Brussel
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- female infertility
01
Overview
Phase 4, randomised trial of corifollitropin alfa and follitropin beta in female infertility (2 arms), sponsored by UZ Brussel. Primary endpoint: Mean serum progesterone level on hCG trigger day. Started Nov 2018; status: active.
02
Design
2 arms- Study design
- Randomized
Lower-dose recombinant FSH after corifollitropin alfa
GnRH antagonist IVF/ICSI protocol with standard corifollitropin alfa (Elonva) and lower-dose recombinant FSH (Puregon) supplementation.
Higher-dose recombinant FSH after corifollitropin alfa
GnRH antagonist IVF/ICSI protocol with standard corifollitropin alfa (Elonva) and higher-dose recombinant FSH (Puregon) supplementation.
03
Who it enrols
Adult women (18–37 years) with subfertility requiring IVF or IVF-ICSI treatment in a GnRH antagonist protocol; women with polycystic ovarian syndrome according to Rotterdam 2004 criteria are excluded.
04
Endpoints
Primary
Mean serum progesterone level on hCG trigger day
Secondary
Number of cumulus-oocyte complexes retrieved
Number of mature oocytes
Number of top-quality embryos on Day 3
Clinical pregnancy rate
Ongoing pregnancy rate
Miscarriage rate
Proportion of patients with serum progesterone > 1.5 ng/mL on hCG day
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