Ovovid trial: the effect of a probiotic micronutrients supplement on oocyte retrieval and quality in oocyte donors. A double blind, randomized controlled trial
摘要
To evaluate whether a micronutrients supplement combined with probiotics improves oocyte retrieval outcomes in normoresponder women undergoing controlled ovarian hyperstimulation for oocyte donation.
MethodsA multicenter, prospective, randomized, double-blind, controlled clinical trial was conducted between July 2022 and July 2024 with 196 normoresponder oocyte donors at three fertility centers in Spain. Participants received either study supplement or a placebo for at least 30 days before and during controlled ovarian hyperstimulation.
ResultsThe intention-to-treat analysis showed a significant increase in the total number of follicles (28.01 ± 10.4 vs. 24.7 ± 7.1; p = 0.0314) and follicles ≥ 16 mm (19.3 ± 8.6 vs. 15.8 ± 6.1; p = 0.0065) in the study group compared to the placebo group. Regarding the quality of MII oocytes, the mean number of good-quality oocytes showed no differences between groups (17.0 ± 7.7 (84.1%) vs. 15.4 ± 8.2 (81.4%); p = 0.2187). The per-protocol analysis (participants who completed the study and adhered fully to the supplement regimen, n = 79) revealed significantly higher total oocytes retrieved (27.7 ± 10.4 vs. 21.2 ± 7.9; p = 0.0045), MII oocytes (22.5 ± 8.89 vs. 17.3 ± 7.25; p = 0.0092), and good-quality MII oocytes (18.97 ± 7.7 vs. 13.42 ± 6.5; p = 0.0019) in the study group.
ConclusionsProbiotic micronutrients supplementation improved follicular development and oocyte yield, in normoresponder oocyte donors, especially when administered according to the recommended protocol. These findings suggest potential benefits for oocyte donation programs; however, further research is needed to establish definitive recommendations.
The study protocol was registered at ClinicalTrials.gov (TRN: NCT05473039) on June 27, 2022.