Effects and safety of Ding Kun Dan on IVF/ICSI-ET outcomes in patients with predicted poor ovarian response:A multicenter randomized clinical trial

Objective:To evaluate whether Ding Kun Dan(DKD)can improve the vitro fertilization/intracytoplasmic sperm injection and embryo transfer(IVF/ICSI-ET)outcomes in patients with predicted poor ovarian response(POR)safely and effectively.Methods:Prospective,multicenter,randomized controlled trial;A total of 278 POR patients were randomized in DKD group or immediate treatment group.Both groups received IVF or ICSI as a standard treatment while in the DKD group,DKD was administrated for 3 months before the IVF/ICSI cycle.The primary outcome was the ongoing pregnancy rate.The secondary outcomes include clinical pregnancy rate,biochemical pregnancy rate,total gonadotropin(Gn)dosage and duration,estradiol(E2)and progesterone(P)levels on human chorionic gonadotropin(hCG)trigger day,cycle cancellation rate,number of oocytes retrieved,high-quality embryo rate and any adverse events.Results:Compared to the immediate IVF treatment group,oral administration of DKD for 3 months before IVF led to a significant increase in ongoing pregnancy rate(30.0%v.s.17.6%,P<0.05),biochemical pregnancy rate(39.2%vs.25.2%,P<0.05),clinical pregnancy rate(36.7%vs.22.7%,P<0.05)and high-quality embryo rate(40.8%vs.32.4%,P<0.05),and a significant decrease in Gn duration(P<0.05).However,no significant differences were found in total dosage of Gn,number of retrieved oocytes,cycle cancellation rate,E2 level and P level on hCG trigger days(P>0.05).No serious adverse events occurred during the intervention period in either group.Conclusion:DKD is a safe and effective intervention to improve the IVF/ICSI-ET outcomes in patients with POR.

A preliminary observation on efficacy of growth hormone on poor ovarian responders in IVF/ICSI cycles

Objective To determine efficacy of gonadotropin （Gn） co-treated with growth hormone （GH） on poor ovarian response （POR） patients undergoing in vitro fertiliza- tion/intracytoplasmic sperm injection （1VF/ICSI）. Methods A total of 58 IVF/ICSI-embryo transfer （ET） cycles in POR patients were retrospectively identified. The POR criteria were defined by Bologna consensus. The cycles were divided into two groups： Gn co-treated with GH group （GH~ group, 25 cycles） and Gn only group （GH- group, 33 cycles）. Results of lVF/ICSI for these two groups were compared. Results The number of oocyte retrieved and the normal fertilization rate in the two groups were no difference （P〉O.05）. High-quality embryo rate and implantation rate in the GH＋ group were 39.6% and 38.5%, respectively, which were slightly higher than those in the GH group （35.9% and 25.0%）, but no difference was found on these two parameters （P〉0. 05）. Conclusion GH, to some extent, can improve the quality of embryo and the implantation rate. Whether GH co-therapy has a definite role in improving the outcome of POR patients still needs further evaluation.