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. 2024 Jul;41(7):1851-1861.
doi: 10.1007/s10815-024-03146-1. Epub 2024 May 29.

The pregnancy outcomes among women receiving individualized algorithm dosing with follitropin delta: a systematic review of randomized controlled trials

Bogdan Doroftei  1   2   3 , Ovidiu-Dumitru Ilie  4 , Ana-Maria Dabuleanu  2   3 , Theodora Armeanu  1   2   3 , Radu Maftei  1   2   3
Affiliations

The pregnancy outcomes among women receiving individualized algorithm dosing with follitropin delta: a systematic review of randomized controlled trials

Bogdan Doroftei et al. J Assist Reprod Genet. 2024 Jul.

Abstract

Purpose: To investigate whether the ovarian stimulation with follitropin delta in an individualized algorithm-based manner is inferior to recombinant human-follicle stimulating's follitropin alfa or follitropin beta conventional dosing regarding a series of established primary endpoints.

Methods: We conducted a registered systematic review (CRD42024512792) on PubMed-MEDLINE, Web of Science™, Cochrane Database of Systematic Reviews, and Scopus. Our search was designed to cover all relevant literature, particularly randomized controlled trials. We critically and comparatively analyzed the outcomes for each primary endpoint based on the intervention, reflected by the positive βhCG test, clinical pregnancy, vital pregnancy, ongoing pregnancy, live birth, live birth at 4 weeks, and multiple pregnancies.

Results: Six randomized controlled trials were included in the quality assessment as priority manuscripts, revealing an 83.3% low risk of bias. Follitropin delta led to non-significant differences in each parameter of interest from positive βhCG test (691; 53.44% vs. 602; 46.55%), ongoing pregnancies (603; 53.79% vs. 518; 46.20%), clinical and vital pregnancies (1,073; 52.80% vs. 959; 47.19%), to live birth and at 4 weeks (595; 54.14% vs. 504; 45.85%) with only 2 losses, and even multiple pregnancies (8; 66.66% vs. 4; 33.33%). However, follitropin delta was well-tolerated among hypo- and hyper-responders without significant risk of ovarian hyperstimulation syndrome and/or preventive interventions in contrast with follitropin alfa or follitropin beta.

Conclusion: The personalized individualized-based algorithm dosing with follitropin delta is non-inferior to conventional follitropin alfa or follitropin beta. It is as effective in promoting a similar response in women without significant comparable adverse effects.

Keywords: FE 999049; Follitropin delta; ICSI; IVF; Infertility; Ovarian stimulation; Pregnancy; Rekovelle.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
PRISMA flow diagram of the systematic review
Fig. 2
Fig. 2
Overall assessment quality of the RTCs based on the ROB-2 tool
See this image and copyright information in PMC

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