Background. Real-world evidence of the efficacy and safety of ferric carboxymaltose (FCM) infusion in Indian pregnant women with iron deficiency anemia (IDA) is lacking. Objective. To assess the efficacy and safety of intravenous (IV) FCM in Indian pregnant women with IDA in 4 weeks in a real-life scenario. Methods. This is a subgroup analysis of our previously conducted retrospective, multicenter, observational, real-world PROMISE study. Data on demographic and hematological parameters, patient-reported adverse events, and physicians’ clinical impressions of efficacy and safety were analysed at 4 ± 1 week. Results. This subgroup analysis included 1191 pregnant women in whom IV FCM resulted in a significant increase in hemoglobin (Hb) by 2.8 g/dL and serum ferritin by 30.03 μg/L at 4 weeks ( P < 0.001 for both). In 103 pregnant women with severe IDA, there was a significant increase in Hb by 3.6 g/dL ( P < 0.001 ), and serum ferritin by 16.96 μg/L ( P = 0.12 ). In 978 pregnant women with moderate IDA, significant improvement in Hb by 2.74 g/dL and serum ferritin by 33 μg/L ( P < 0.001 for both) was noted. Similarly, there was a significant increase in red blood cell count, hematocrit, mean corpuscular volume, and mean corpuscular hemoglobin ( P < 0.001 for all). In pregnant women with mild IDA (n = 26), Hb increased significantly by 1.99 g/dL ( P < 0.001 ). Adverse effects were reported in 8.6% of pregnant women. No new safety signals or serious adverse effects were observed. Based on physicians’ global assessment, good to very good efficacy and safety of IV FCM was noted in 99.2% and 98.6% of pregnant women, respectively. Conclusions. IV FCM rapidly corrected anemia in a short period of 4 weeks with favorable safety in the second and third trimester of pregnancy with all severities of IDA (severe, moderate, and mild). The physicians’ favorable global assessment of FCM’s efficacy and safety in pregnant women with IDA supports its use in daily clinical practice. This trial is registered with CTRI/2021/12/039065.
Rising number of infertile males in India provokes the need of evidence-based comprehensive formula addressing unattended causes of male infertility. There is an innovative product*, a combikit available in Indian market, containing 30 tablets of antioxidant, multivitamin, amino acid and mineral tablets, with documented evidence on ingredients in treatment of male infertility, and 25 tablets of clomiphene citrate which is a timetested drug in treatment of male infertility (in particular oligospermia and/or asthenospermia). In order to assess efficacy of the product in Indian infertile male patients, we undertook phase IV multicentric clinical study, at 18 centers across India in 100 patients.Very high couple pregnancy rate of 53% was reported. As first line treatment of male infertility (in particular oligospermia and/or asthenospermia), the use of this innovative product therefore holds a strong promise.
Background: With recent improvements in the assisted reproductive technology (ART), there has been a growing tendency that bypasses diagnostic laparohysteroscopy and proceeds directly to ART. Therefore, the value of diagnostic laparohysteroscopy in current fertility practice is under debate. In the present study, we evaluated the usefulness of diagnostic laparoscopy and hysteroscopy for patients with infertility.Methods: This retrospective study was conducted at Safal Hospital, Nagpur from January 2017 to July 2017. 80 patients were selected for this study who had undergone diagnostic laparohysteroscopy for infertility.Results: In present study, out of 80 patients studied, 66.25% patients had normal hysteroscopy findings, in 10% of patients, tubal cannulation was done for cornual block, in 6.25% of patients, resection of uterine septum was done, adhesiolysis for asherman’s syndrome was done in 5% of patients, endometrial polyp was removed in 5% of patients, 2.5% patients had resection of submucous fibroid. In 5% patients, cervical dilatation for fibrosis was done in 5% of patients. 68.75% had normal laparoscopy findings, in 8.75% of patients, ovarian drilling for PCOS was done, adhesiolysis for peritubal adhesions was done in 6.25% patients, fulguration of endometriosis was done in 6.25% patients, salpingectomy for hydrosalpinx was done in 5% patients, aspiration of ovarian cyst was done in 2.5% patients.Conclusions: Diagnostic hysterolaparoscopy is an effective diagnostic and therapeutic modality for certain significant and correctable abnormalities in pelvis, tubes and uterus which are missed by other imaging modalities.
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