Efficacy of the combination of antimicrobial therapy with immunomodulators in the management of immunological female infertility due to anti-sperm antibodies associated with bacterial vaginosis during unexplained infertility: double-blind factorial randomised controlled trial
Abstract
Background: Unexplained infertility (UI) is a subject of major concern in reproduction and can be associated with bacterial vaginosis (BV) and/or antisperm antibodies (ASA), yet therapeutic strategies for these conditions in resource-limited settings are poorly defined. This study aimed to evaluate the efficacy of immunomodulators compared with placebo following antimicrobial therapy among infertile women with UI linked to ASA and BV.
Methods: This double-blind, 2 × 3 factorial randomised controlled trial was conducted at a tertiary referral hospital in Kisangani, Democratic Republic of the Congo. 123 women with UI, positive ASA, and BV were randomised to receive either metronidazole alone or combined antimicrobial therapy (metronidazole, clotrimazole, and clindamycin) for Factor 1, followed by prednisolone, zinc acetate, or placebo (paracetamol 100 mg) for Factor 2. The primary outcome was time to clinical pregnancy within six months, analysed in the modified intention-to-treat population as a time-to-event endpoint using Kaplan-Meier methods, the log-rank test, and Cox proportional hazards models. The study protocol was initially approved by the provincial health district ethics committee (701/FBL/DPS/TSHOPO/SEC/0173/2023). The trial has been retrospectively registered with the Pan African Clinical Trials Registry on 08 October 2024 under the identifier PACTR202410672612184.
Results: Among 123 participants, immunomodulators significantly increased clinical pregnancy rates…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 123 participants or records.
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