Comparison of Adding Sildenafil Versus Estradiol to Clomiphene Citrate on the Applebaum Score and Pregnancy Rate in Patients With Unexplained Infertility: A Double-Blind Randomized Controlled Trial.

Autor:	Bosenge-Nguma JD; Department of Obstetrics and Gynaecology, Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, COD., Modia O'yandjo A; Department of Obstetrics and Gynaecology, Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, COD., Marini Djang'eing'a R; Pharmaceutical Analytical Chemistry Laboratory and Interdisciplinary Drug Research Centre, University of Liège, Liège, BEL., Skv J; Department of Obstetrics and Gynaecology, Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, COD., Labama Otuli N; Department of Obstetrics and Gynaecology, Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, COD., Heng Boon Chin A; Reproductive Medicine, Singapore Fertility and IVF Consultancy Pvt Ltd, Singapore, SGP., Katenga Bosunga G; Department of Obstetrics and Gynaecology, Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, COD.
Jazyk:	angličtina
Zdroj:	Cureus [Cureus] 2024 Jun 28; Vol. 16 (6), pp. e63414. Date of Electronic Publication: 2024 Jun 28 (Print Publication: 2024).
DOI:	10.7759/cureus.63414
Abstrakt:	Background: Both sildenafil and estradiol are seen to improve endometrial thickness in patients with infertility who are undergoing clomiphene induction cycles. However, the correlation between endometrial thickness and pregnancy rate is debatable. This study investigated the effect of adding oral sildenafil to clomiphene citrate (CC), compared to adding estradiol valerate, on the uterine biophysical profile (Applebaum score) and pregnancy rate. Methods: This was a double-blinded, randomized controlled trial conducted in Kisangani in the Democratic Republic of the Congo from October 1, 2021, to October 31, 2023. Patients with unexplained infertility were randomly assigned to one of two groups: the interventional, which was given CC (2 x 50 mg/day from day 3 to day 7 of the menstrual cycle) + sildenafil (2 x 25 mg/day orally from day 8 to day 12) or (ii) the control group, which was given CC (similar dosage as the intervention group) + EV (2 x 2 mg/day orally from day 8 to day 12), for a maximum of three cycles. Applebaum scores and clinical pregnancy rates were measured. Results: Patients in the sildenafil and EV groups were similar in mean age (29.04 versus 28.89 years). Of the 74 patients enrolled in each group, 71 in the sildenafil group and 72 in the EV group received treatment and were followed to completion. The Applebaum scores were significantly higher in the sildenafil group than in the EV group (17.05 versus 15.14, respectively, P=0.000). In the sildenafil group, the clinical pregnancy rate was also significantly higher, at 28.92% versus 20.83% in the EV group (P = 0.04). Conclusion: As compared to EV, the oral addition of sildenafil to CC is associated with a good Applebaum score and a high rate of clinical pregnancy in patients with unexplained infertility. Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Ethics Committee of the University of Kisangani issued approval UNIKIS/CER/08/2021. The study was conducted in accordance with the declaration of Helsinki. Patients were provided with explanations of the study's objectives and procedures prior to participation. The trial was registered in the Pan African Clinical Trials Registry with registration number: PACTR202310849449401. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: This study was financially supported by a grant from the Faculty of Medicine and Pharmacy of the University of Kisangani and the Fondation des Anges. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work. (Copyright © 2024, Bosenge-Nguma et al.)
Databáze:	MEDLINE
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