The efficacy of vitamin D combined with clomiphene citrate in ovulation induction in overweight women with polycystic ovary syndrome: a double blind, randomized clinical trial.

PURPOSE: The aim of this study was to assess the effect of vitamin D supplementation on ovulation rate in overweight subfertile women with PCOS undergoing ovulation induction. METHODS: This was a single center, parallel-groups, double-blind, and placebo-controlled randomized trial involving 186 eligible women undergoing induction of ovulation with clomiphene citrate (Clomid®, Aventis) 50 mg tablet twice daily starting from the third day of menstrual cycle and for 5 days combined with either oral Vitamin D (ossofortin®, EVA PHARMA) 10,000 IU twice weekly and calcium (calciprex®, Marcyrl Pharmaceutical Industries) 1250 mg twice daily or to receive a placebo with calcium for three successive induction cycles. The vitamin D or placebo supplementation started 1 month before induction cycles (total four cycles). Cycles were monitored with ultrasound follicle tracking and mid-luteal serum progesterone measurement. The primary outcome was the ovulation rate after three induction cycles. RESULTS: The study was performed during the period between January 2018 and September 2018, Eighty six (92.5%) women in the treatment group and 73 (78.5%) in the control group had successful ovulation (p = 0.007). The absolute and relative risk reduction was 14% and 65% respectively. Biochemical and clinical pregnancy occurred in 61.3 and 50.5% in the treatment group, and in 49.5 and 39.8% in the control group (p = 0.105 and 0.141 respectively). CONCLUSION: In subfertile women with PCOS undergoing induction of ovulation, vitamin D supplementation significantly improved the ovulation rate; however, there was no effect on clinical or biochemical pregnancy.

Agreement between transvaginal ultrasound and saline contrast sonohysterography in evaluation of cesarean scar defect.

OBJECTIVES: to assess the agreement between saline contrast sonohysterography (SCSH) and transvaginal sonography (TVS) in the evaluation of cesarean section scar defect (CSD) regarding its width, depth, and shape and also in assessing the anterior myometrium, and residual myometrium related to the scar. MATERIAL AND METHODS: a prospective study during the period between August 2017 and January 2018 was conducted in which 102 consecutive participants underwent primary cesarean section in Ain Shams University Maternity Hospital were assessed six weeks after CS to evaluate for CSD presence by using both SCSH and TVS. RESULTS: CSD could be detected only in 59.8% of women by TVS and 70.5% by SCSH with good agreement strength (Cohen kappa = 0.805). TVS was 84.72% sensitive and 100.00% specific in identifying CSD diagnosed by SCSH. The PPV, NPV, and accuracy of TVS were 100.00%, 73.17%, and 89.21%, respectively. The mean anterior myometrial thickness (AMT) did not differ when assessed by both TVS and SCSH, while the mean niche width was 2.56 ± 1.98 mm with SCSH compared to 2.17 ± 1.63 mm with TVS(r = 0.954), and its mean depth was 2.76 ± 2.02 mm for SCSH and 1.57 ± 1.51 mm in TVS(r = 0.812). The mean residual myometrium was 10.09 ± 2.74 mm in SCSH while was 11.18 ± 2.50 mm for TVS(r = 0.914) CONCLUSION: cesarean scar defects in non-pregnant women are better evaluated at SCSH than at unenhanced TVS as more defects detected by SCSH and better evaluation of its shape, borders and size.

The effect of alpha lipoic acid on uterine wound healing after primary cesarean section: a triple-blind placebo-controlled parallel-group randomized clinical trial.

PURPOSE: To investigate the effect of alpha lipoic acid (ALA) on uterine wound healing after primary cesarean section (CS). METHODS: A parallel-group, triple-blind, placebo-controlled randomized clinical trial was conducted in Ain Shams University Maternity Hospital, Cairo, Egypt, involving 102 women undergoing pre-labor primary CS. The participants were randomly assigned using a computer-generated list of random numbers to receive oral ALA or a placebo twice daily for 6 weeks after CS. Allocation to either group was in a 1:1 ratio by an independent statistician (not involved in the treatment or data collection). The primary outcome was the presence of CS defect and measuring its depth and width. Secondary outcomes were measurements of the anterior myometrial and residual myometrium thicknesses, healing ratio and the presence of intrauterine adhesions. Assessment was done using saline contrast sonohysterography. RESULTS: Twenty (39.2%) women in the treatment group and ten (19.6%) controls had no niche (P value = 0.03, 95% CI - 0.388, - 0.0037). The absolute and relative risk reduction of forming a niche was 19.61% and 24.39%, respectively. The number of women needed to treat was five to avoid one niche formation. ALA use was associated with gastrointestinal upset in only three participants; however, none of the women withdrew during the study. CONCLUSION: In women undergoing primary CS, the administration of ALA for 6 weeks postpartum improved uterine healing and decreased the incidence of scar niche.

Combined oral prednisolone and heparin versus heparin: the effect on peripheral NK cells and clinical outcome in patients with unexplained recurrent miscarriage. A double-blind placebo randomized controlled trial.

PURPOSE: To evaluate the efficacy of the use of oral Prednisolone and heparin versus the use of heparin alone in treatment of patients with unexplained recurrent miscarriage. METHODOLOGY: The study was a double-blind placebo randomized control trial conducted on 160 patients with unexplained recurrent miscarriage. Patients recruited were randomized into two groups. The first group received oral Prednisolone in addition to low dose aspirin and heparin, while the other group received a placebo in addition to low dose aspirin and heparin. A peripheral venous blood sample was taken from all included patients before starting treatment and collected in heparinized tubes. Natural Killer (NK) cells were checked in each sample and then re-checked in another sample at 20 weeks of gestation. RESULTS: We found that in the prednisolone group, 70.3 % of women had successful outcome (defined as an ongoing pregnancy beyond 20 weeks gestation), while 29.7 % miscarried before this gestation. On the contrary, among women in the placebo group, 9.2 % had successful outcome while 90.8 % miscarried before 20 weeks, which was statistically significant. On the other hand, we found that there were no significant paired differences between initial serum levels of the NK cells markers CD16 and CD56 and their levels at 20 weeks gestation in both groups. CONCLUSION: The addition of prednisolone to heparin and low dose aspirin might be beneficial in patients with unexplained recurrent miscarriage, and this effect might be due to a suppressive effect of steroids on the peripheral CD16 NK cells concentration.