Aim: To evaluate the impact of adding L-carnitine (LC) to usual endometrial preparation on endometrial receptivity in women with at least one prior implantation failure during intra-cytoplasmic sperm injection (ICSI)/frozen embryo transfer (FET) cycles. Methods: This prospective, double-blinded, placebo-controlled, randomized, parallel-group, concealed allocation, superiority trial was conducted at a private specialized IVF center at Benha, El-Qalubia, Egypt, between November 2015 and May 2017. The study included 124 infertile couples with at least one prior implantation failure (PIF) in ICSI/FET cycles ; they were allocated to receive usual endometrial preparation plus 3 gm LC/daily until transfer (62) or received placebo (62) plus usual estradiol valerate. Outcomes were endometrial thickness, implantation rate, chemical pregnancy rate, clinical pregnancy rate, ongoing implantation rate, ongoing pregnancy rate, live birth rate and live borne babies rate. Results: Infertile women with at least one prior implantation failure in ICSI/FET cycles co-treated with L-Carnitine showed significantly thicker endometrium (mm) 9.8 ± 1.2 in LC vs 8.4 ± 0.7 in non LC with ∆ (95% CI) = 1.4 (1.74, 1.05) and higher chemical pregnancy rate 46 (74.2%) in LC vs 22 (35.4%) in non LC with ∆PP (95% CI) = 38.8 (71.46; 52.96) and RR (95% CI) = 2.09 (1.44, 30.1) and NNT (95% CI) = 3 (2, 5). Also, higher clinical pregnancy rate was (34 (54.8%)) in LC vs 14 (22.6%) in non LC with ∆PP (95% CI) = 32.2% (15.13, 46.77) and RR (95% CI) = 2.4 (1.45, 40.5) and NNT (95% CI) = 4 (3-7) as well as higher live birth rate and live bone rate of singletons fetus (P < 0.05). Conclusion: Data presented in this trial supported the supplementation of LC to usual endometrial preparation in women with at least one prior implantation failure in ICSI/FET cycles as it improved endometrial receptivity indicated by improved implantation rate, clinical pregnancy rate and live birth rate.
Aim of work:To estimate serum 25-hydroxy vitamin D (25OH-VD) and insulin, and fasting blood glucose (FBG) early in pregnancy, determine the frequency and severity of insulin resistance (IR), gestational diabetes mellitus (GDM) and pre-eclampsia (PE) during pregnancy and the impact of VD supplemental therapy (VD-ST) on these effects. Patients and Methods: 494 pregnant women fulfilling the inclusion criteria were randomly divided into two equal groups: Study group received VD-ST as a daily oral dose of 1000 IU soft gels with meal since 6th week till delivery, while control group did not receive VD-ST. All women gave blood samples for colorimetric estimation of FBG and ELISA estimation of serum insulin and 25-OH-VD levels. Evaluated parameters included body mass index (BMI), VD sufficiency status and homeostasis model assessment IR (HOMA-IR) score. Oral glucose tolerance test for diagnosis of GDM was performed at the 20th, 28th and 36th week GA and blood pressure was measured regularly at follow-up visits for diagnosis of PE. Results: At time of enrolment, 405 women (81.9%) were overweight-obese, 86 women (17.4%) had IR and only 63 women (12.8%) had sufficient serum 25OH-VD level. At 3rd trimester, 68 women (13.8%) developed GDM, 71 women (14.4%) developed PE and 23 women (4.7%) developed both with significantly lower incidence in women who received VD-ST. Frequency of GDM and PE showed positive significant correlation with BMI and HOMA-IR score, while showed negative significant correlation with serum 25OH-VD. ROC curve analysis defined low 25OH-VD level and high HOMA-IR score as significant sensitive predictors for development of both GDM and PE ; while receiving VD-ST was the significant specific predictor for possibility of amelioration of such event. Kaplan-Meier regression curve defined a cumulative hazard for developing both GDM and PE of <20% with and 60% without VD-ST. Conclusion: VD deficiency-insufficiency is a problem that requires national evaluation for predisposition and progress. The triad of maternal hypovitaminosis D, obesity and IR is associated with development of GDM and/or PE. The proposed VD supplementation regimen effectively reduced the frequencies of pregnancy-associated or induced complications; so it is effective to break that triad.
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