No abstract

Study questions Does ICSI result in a higher live birth rate as compared with conventional IVF in couples with non-male factor infertility? What is known already ICSI is primarily indicated for severe male factor infertility. While the use of ICSI for couples with non-male factor infertility has been increasing worldwide, this is not supported by data from randomised controlled trials. Evidence from non-randomised studies suggest no benefit from ICSI compared with conventional IVF in non-male factor infertility, if not a harm. Study design, size, duration This randomised, open-label, multi-centre trial aims to compare the effectiveness of one ICSI cycle and one conventional IVF cycle in infertile couples with non-male factor infertility. A total of 1064 couples will be randomly allocated to an ICSI group and a conventional IVF group. The estimated duration of the study is 30 months. Participants/materials, setting, methods Eligible couples are those whose husbands’ total sperm count and motility are normal, have undergone ≤2 previous IVF/ICSI attempts, use antagonist protocol for ovarian stimulation, agree to have ≤2 embryos transferred and are not participating in another IVF study at the same time. Women undergoing IVM cycles, using frozen semen or having a poor fertilisation (≤25%) in previous cycle will not be eligible. Couples will be randomised to undergo ICSI or conventional IVF (1:1) with ongoing pregnancy resulting in live birth after the first embryo transfer of the started treatment cycle as the primary endpoint. All analyses will be conducted on an intention-to-treat basis. Effect sizes will be summarised as relative risk (RR), with precision evaluated by 95% CIs. STUDY FUNDING/COMPETING INTEREST(S) All authors declare having no conflict of interests with regards to this trial. This work was supported by a grant from MSD [MISP #57508]. Trial registration number NCT03428919. Trial registration date 8 February 2018. DATE OF FIRST PATIENT’S ENROLMENT 16 March 2018.

Background: Several studies have demonstrated that vitamin D (vitD) might play an important role in the reproductive system due to expression of vitD receptor and vitD-metabolizing enzymes in many reproductive tissues. VitD deficiency has been associated with increased risk of obstetric complications. However, the effect of vitD levels on in vitro fertilization (IVF)/ICSI outcomes is not fully understood. Evidence shows that women with adequate vitD levels might have higher pregnancy rates. This study evaluated the association between serum vitD levels and IVF/ICSI outcomes. Methods: This multicenter, retrospective cohort study was conducted at IVFMD, My Duc Hospital and IVFMDPN, My Duc Phu Nhuan Hospital, Ho Chi Minh City, Vietnam between November 2017 and July 2019. Vietnamese patients aged 18-40 years with serum vitD (25(OH)D) samples collected before starting controlled ovarian stimulation and undergoing embryo transfer were eligible. Patients were divided into four groups based on 25(OH)D levels: <10 ng/mL, 10 to <20 ng/mL, 20 to <30 ng/mL, and ≥30 ng/mL. The primary outcome was ongoing pregnancy rate. Results: Of 3779 patients recruited, 25(OH)D levels were <10 ng/mL in 564 (14.9%), 10 to <20 ng/mL in 436 (11.5%), 20 to <30 in 1,142 (30.2%), and ≥30 ng/mL in 1,637 (43.3%). Ongoing pregnancy rates were similar across the four subgroups (36%, 40%, 36%, and 36%, respectively; p 0.409). The number of oocytes retrieved, embryos, clinical pregnancy, implantation, and miscarriage rates did not differ significantly between subgroups. Conclusions: In this analysis, serum vitD levels did not appear to be correlated with pregnancy outcomes in patients undergoing IVF/ICSI.

No abstract

Background: Gonadotropins have been recommended to improve ovulation, pregnancy and live birth rates in polycystic ovary syndrome (PCOS) patients with anovulatory infertility and clomiphene citrate (CC) resistance. However, this could increase the risk of ovarian hyperstimulation syndrome (OHSS). Gonadotropin-releasing hormone agonist (GnRHa) triggering could significantly reduce the risk of OHSS in patients undergoing in vitro fertilisation. However, data on the use of GnRHa in intrauterine insemination (IUI) is limited. This study compared the effectiveness of GnRHa and human chorionic gonadotropin (hCG) for ovulation induction in PCOS patients undergoing IUI. Methods: This non-inferiority, single-centre, randomised controlled trial was conducted at IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam between April 2016 and May 2018. PCOS patients aged 18–37 years with CC resistance and [Formula: see text] 3 developing ([Formula: see text] 16 mm) follicles on trigger day after stimulation with gonadotropins were eligible. Those with uterine abnormalities or tubal damage or inseminated with frozen semen were excluded. Triptorelin 0.1 mg or hCG 5000 IU was used when there was [Formula: see text] 1 follicle of [Formula: see text] 17 mm. IUI was performed at 36 hours after triggering. Primary outcome was ongoing pregnancy. Secondary outcomes were clinical pregnancy, multiple pregnancy, miscarriage and OHSS. Results: A total of 380 patients were randomised (190 per group). Treatment groups had similar characteristics at baseline. Ongoing pregnancy rate was 23.7% in the GnRHa group versus 25.3% in the hCG group (Relative risk 0.94; 95% confidence interval, 0.66–1.34; p [Formula: see text] 0.81). Secondary outcome parameters were also not significantly different between the two groups. There were two cases of mild OHSS in the hCG group and none in the GnRHa group. Conclusion: 0.1 mg triptorelin was non-inferior to 5000 IU hCG IU in PCOS patients undergoing ovulation induction by hMG followed by IUI with respect to pregnancy outcomes.