P-667 Follitropin delta for ovarian stimulation in daily practice in a Dutch IVF centre
Authors: Boom P , Laven J 
Published: June 2022

Abstract

Study question
This study reports individualized follitropin delta dosing in a real life setting in patients undergoing IVF treatment.

Summary answer
The use of follitropin delta, in real-world clinical setting with a broad and varied patient population, shows results aligned with the ESTHER-1 registration trial (NCT01956110).

What is known already
Individualized follitropin delta dosing based on anti-Müllerian Hormone (AMH) and body weight (BW) is as effective as treatment with Chinese hamster ovary (CHO) derived follitropin alfa, and leads to a more predictable ovarian response and improved safety. Results of the ESTHER-1 trial show: similar pregnancy rates and less frequent excessive ovarian response compared to women treated with follitropin alfa. Moreover, the incidence of ovarian hyperstimulation syndrome (OHSS) was reduced, fewer poor responses occurred in women with AMH &lt;15 pmol/L and fewer excessive responses in women with AMH ≥ 15 pmol/L.

Study design, size, duration
Descriptive analysis from real-world data obtained in the Erasmus University Medical Centre. Since its introduction in 2017, 2369 treatment cycles have been performed with follitropin delta in our center. In 499 patients, with a regular ovulatory menstrual cycle, follitropin delta was used in a GnRH-antagonist protocol in their first IVF cycle in 2017. Subsequent fresh embryo transfers were done on day 5. EMC patients were compared to patients in the ESTHER-1 trial using follitropin delta.

Participants/materials, setting, methods
Women are prescribed follitropin delta according to the dose algorithm based on the patient’s BW and serum AMH levels as measured by the automated Elecsys® AMH plus immunoassay (Roche Diagnostics). Results of the treatment were collected from the clinical records. The outcomes of the first IVF cycles with follitropin delta are reported. Data were expressed as mean (SD) or percentages and statistically analyzed using t-test and chi-square test.

Main results and the role of chance
EMC patients were significantly older (33.9 (4.5) vs. 33.4 (3.9) years (p &lt; 0.01) and had higher AMH serum levels (21.5 (13.2) vs. 19.4 (14.6) pmol/l (p &lt; 0.001) compared to those in the ESTHER-1 trial. Less patients started IVF in a naïve cycle (75.4% vs. 100% (p &lt; 0.001) and BW was higher (68.6 (11.1) vs. 64.7 (10.7) kg (p &lt; 0.01).
Retrieved number of oocytes (10.6 (5.7) vs. 10.0 (5.6) (p &lt; 0.05), number of cleavage stage embryos (6.1 (3.6) vs. 5.4 (3.7) (p &lt; 0.001), number of cryopreserved embryos (2.3 (2.3) vs. 1.9 (2.4) (p &lt; 0.001) and proportion of women with embryos cryopreserved (72.4% vs. 63.4% (p &lt; 0.01) were all significantly higher in the EMC patients. Proportion of women with 8-14 oocytes was similar (47.3% vs. 43.3% of patients (NS). Women with AMH &lt;15 pmol/L had more oocytes retrieved (8.9 (4.5) vs. 8.0 (4.3) (p &lt; 0.01). Women with AMH ≥15 pmol//L had similar numbers of oocytes retrieved (11.4 (6.0) vs. 11.6 (5.9) (NS). More cycles were cancelled with an insufficient number of follicles in the overall population (7.4% vs. 3.8% (p &lt; 0.01). Hospitalization due to OHSS was similar (0.6% vs. 0.3% (NS).
Positive hCG test (40.7% vs. 38.6% (NS) and ongoing pregnancy rate per started cycle (32% vs. 30.7% (NS) were similar.

Limitations, reasons for caution
This is a retrospective analysis of the use of follitropin delta in patients in daily clinical practice. As this population was drawn from daily clinical practice, it is a heterogeneous population in which no strict in- or exclusion criteria were applied.

Wider implications of the findings
Individualized follitropin delta treatment of a broad patient population as presented here shows clinically similar results in ovarian response compared to the previously reported ESTHER-1 trial. Moreover, pregnancy rates were also similar even though patient characteristics were slightly different.

Trial registration number
not applicable