OBJECTIVE: to detect the impact of growth hormone (GH) co-treatment to the long down regulation protocol, on the outcomes of IVF/ICSI cycles in poor responders. STUDY DESIGN: this parallel open label randomized control trial was conducted in a university hospital. It included 240 females satisfying the bologna criteria for poor responders. The enrolled females were randomized into 2 groups: A (long/GH) receiving GH adjuvant therapy to the long protocol and group B (control) receiving the long protocol alone. The main outcome measure was the live birth rate (fresh, frozen and cumulative). RESULTS:GH supplementation improved the number of collected oocytes (5.4 ± 1.7 vs. 4.3 ± 2.1), MII oocytes (4.1 ± 2.1 vs. 2.1 ± 1.4), fertilized oocytes (4.0 ± 2.2 vs. 2.0 ± 1.2), transferred embryos (2.4 ± 0.9 vs. 1.6 ± 1.1) and cryopreserved (0.5 ± 0.7 vs. 0.2 ± 0.5). There was no significant difference in the live birth rate whether fresh (17.5% vs. 14.1%) or cumulative (18.3% vs. 14.7%). CONCLUSIONS: Further studies are needed to know the true impact of adding GH to the induction protocols in poor responders, as there was no difference in the live birth rates between the study groups, indicating a lack of trend toward benefit from GH supplementation in poor responders. CLINICAL TRIAL REGISTRATION: NCT02338206.
RCT Entities:
OBJECTIVE: to detect the impact of growth hormone (GH) co-treatment to the long down regulation protocol, on the outcomes of IVF/ICSI cycles in poor responders. STUDY DESIGN: this parallel open label randomized control trial was conducted in a university hospital. It included 240 females satisfying the bologna criteria for poor responders. The enrolled females were randomized into 2 groups: A (long/GH) receiving GH adjuvant therapy to the long protocol and group B (control) receiving the long protocol alone. The main outcome measure was the live birth rate (fresh, frozen and cumulative). RESULTS: GH supplementation improved the number of collected oocytes (5.4 ± 1.7 vs. 4.3 ± 2.1), MII oocytes (4.1 ± 2.1 vs. 2.1 ± 1.4), fertilized oocytes (4.0 ± 2.2 vs. 2.0 ± 1.2), transferred embryos (2.4 ± 0.9 vs. 1.6 ± 1.1) and cryopreserved (0.5 ± 0.7 vs. 0.2 ± 0.5). There was no significant difference in the live birth rate whether fresh (17.5% vs. 14.1%) or cumulative (18.3% vs. 14.7%). CONCLUSIONS: Further studies are needed to know the true impact of adding GH to the induction protocols in poor responders, as there was no difference in the live birth rates between the study groups, indicating a lack of trend toward benefit from GH supplementation in poor responders. CLINICAL TRIAL REGISTRATION: NCT02338206.