Cost-effective Treatment of Unexplained Infertility: A Prospective Multicenter, Double-blinded, Randomised Controlled Study

RES/013/2023

The issue of unexplained infertility that Southam brought up in 1960 is still a problem today. Despite improvements in infertility assessment, many couples still don't know why they are infertile. Even with the use of the most advanced ovulation detectors, fallopian tube patency tests, and semen evaluations, competency cannot identify every potential flaw in the intricate processes leading to conception. Unexplained infertility will be a challenge for both biological and clinical researchers since it results from these gaps in our understanding of fertilization and from our incapacity to use all of the current evidence-based information.

2024-01-01

2025-09-03

2025-09-03

Not yet recruiting

Early phase I

900

Inclusion Criteria: * Saudi women. * Married women in a stable, continuous, unprotected heterosexual relationship (cohabitating with their husbands). * Aged between 18 to 35 years old. * Non-smoking. * Non-alcohol drinking. * With a body mass index \< 30 Kg/M2, * Who are looking healthy (all their infertility-workup investigations including male partners' seminal analysis were within normal range) * Failed to conceive spontaneously within 2 years of marriage without evident cause (cases with primary infertility). Exclusion Criteria: * All non-Saudi women, * Saudi unmarried women (not yet engaged in sexual activity), * Married women with age less than 18 or more than 35 years old, * Patients with secondary infertility, * Cigarette smokers. * Alcohol drinking. * BMI \> 30 Kg/M2, * Pregnant women. * Breastfeeding women. * With known pathological cause (either male or female factor), * With hypersensitivity to any of medication planned to be used in the study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Couples with unexplained infertility (n=900) were divided into three equal groups. Group-A received Sildenafil Citrate (Viagra®) and Clomiphene Citrate (Clomid®). Group-B received Clomiphene Citrate (Clomid®) and subjected to intra-uterine insemination (IUI). Group-C received Clomiphen Citrate (Clomid®) alone (Control group).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double (Clinical investigator; the Radiologist, and Biostatistician; data analyst).', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 900, 'type': 'ESTIMATED'}}

2023-12-21