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Clinical Outcomes of Melatonin Supplementation As Adjuvant Therapy of In-Vitro Fertilization - Trial PACTR202308477172970

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PACTR202308477172970
Early Phase 1
Not yet recruiting
Trial Details
Pan Africa Clinical Trials Registry โ€ข PACTR202308477172970
Pure Global
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Clinical Outcomes of Melatonin Supplementation As Adjuvant Therapy of In-Vitro Fertilization
Clinical Outcomes of Melatonin Supplementation as Adjuvant Therapy: A Randomized Controlled Trial Amongst Women Undergoing In-Vitro Fertilization at Jos University Teaching Hospital, Plateau State, North-Central, Nigeria

Study Focus

Obstetrics and Gynecology

Sponsor & Location

aladeshuyi Ayo

Dr. Aladeshuyi Ayo

Nigeria

Timeline & Enrollment

Early Phase 1

Sep 30, 2023

Jan 31, 2024

Summary

Background: The unchecked proliferation of oxidative by-products has been linked to poor spermatozoa quality, aggressive follicular fluid micro-environment, impaired oocyte maturation, hostile fertilization milieu, reduced fecundability, and most especially poor treatment predictions. These may increase the number of attempts needed to go through the usual high-tech, high-cost, pocket-draining, and often times psycho-socially demanding fertility interventions (all in a bid for a favorable outcome). Unfortunately, such multiple attempts of therapies are astronomic luxuries to most couples in low- and middle-income global societies like ours. In the quest for a technically unambiguous, cost-effective, low-tech, non-invasive, broad-spectrum, and more prognostically reassuring remedy to solve this age-long problem, this study intends to find out if melatonin supplementation would translate to a better prognosis as adjuvant therapy to available standard fertility treatments. A positive finding could be adopted in low-resource locales in the West Africa region and beyond. Specific Objectives1. To determine and compare the proportion of clinical pregnancies among women on melatonin supplementation as an adjuvant to standard fertility treatments and those not on melatonin supplementation at Jos University Teaching Hospital, Plateau State.2. To assess the predictors of clinical pregnancy in women who had melatonin supplementation and women who had placebos before undergoing assisted fertility therapy at Jos University Teaching Hospital, Plateau State.

ICD-10 Classifications

Obstetric and gynaecological devices associated with adverse incidents
Obstructed labour due to other maternal pelvic abnormalities
Obstetric and gynaecological devices associated with adverse incidents : miscellaneous devices, not elsewhere classified
Obstetric and gynaecological devices associated with adverse incidents : diagnostic and monitoring devices
Other complications of obstetric surgery and procedures

Data Source

Pan Africa Clinical Trials Registry

PACTR202308477172970

Non-Device Trial