Cost-effective Treatment of Unexplained Infertility

NCT06178523 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: RES/2024/1
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unexplained Infertility

Keywords

Clomiphene citrate; Sildenafil citrate; Intrauterine insemination; Unexplained Infertility

Outcome Measures

Primary Outcomes (1)

• Pregnancy outcome

  Ultrasound confirmation of intrauterine fetal heartbeat.

  7 weeks after positive pregnancy test.

Study Arms (3)

Sildenafil & Clomiphene Group

ACTIVE COMPARATOR

Sildenafil Acetate (Viagra®) 25 mg as a vaginal tablet 6 hourly for 10 days starting from the fifth day of the menstrual cycle + Clomiphene Citrate (Clomid®) 100 mg for 5 days starting from the second day of the menstrual cycle. Follow-up by resistance index (RI), pulsatility index (PI), and maximum velocity (T-max) of sub-endometrial, uterine, and ovarian vessels measured by using TVS Colour Doppler ultrasound.

Drug: Clomiphene Citrate.; Drug: Sildenafil Citrate

IUI & Clomiphene Group

ACTIVE COMPARATOR

Clomiphene Citrate (Clomid®) 100 mg for 5 days starting from the second day of the menstrual cycle + Intrauterine insemination (IUI) 42 hours after human chorionic gonadotropin (Pregnyl®) 10,000 IU injection IM. Follow-up by resistance index (RI), pulsatility index (PI), and maximum velocity (T-max) of sub-endometrial, uterine, and ovarian vessels measured by using TVS Colour Doppler ultrasound.

Drug: Clomiphene Citrate.; Procedure: Intrauterine Insemination

Clomiphene only Group

PLACEBO COMPARATOR

Clomiphene Citrate (Clomid®) 100 mg for 5 days starting from the second day of the menstrual cycle. Follow-up by resistance index (RI), pulsatility index (PI), and maximum velocity (T-max) of sub-endometrial, uterine, and ovarian vessels measured by using TVS Colour Doppler ultrasound.

Drug: Clomiphene Citrate.

Interventions

Clomiphene Citrate. DRUG

Clomiphene Citrate (Clomid®) 100 mg for 5 days starting from the second day of the menstrual cycle (Groups A, B, and C).

Also known as: Clomid®

Clomiphene only Group; IUI & Clomiphene Group; Sildenafil & Clomiphene Group

Sildenafil Citrate DRUG

Sildenafil Acetate (Viagra®) 25 mg as a vaginal tablet 6 hourly for 10 days starting from the fifth day of the menstrual cycle (Group-A).

Also known as: Viagra®

Sildenafil & Clomiphene Group

Intrauterine Insemination PROCEDURE

IUI (Group-B).

Also known as: IUI

IUI & Clomiphene Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Females with unexplained infertility.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Batterjee Medical College: lead

Study Sites (1)

Batterjee Medical College

Jeddah, Mecca Region, 21442, Saudi Arabia

Location

MeSH Terms

Interventions

Clomiphene; Sildenafil Citrate

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Sulfonamides; Amides; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Remah M Kamel, PhD

  Batterjee Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double (Clinical investigator; the Radiologist, and Biostatistician; data analyst).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynaecology

Model Details: 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).

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: December 21, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)