NCT03481582

Effect of Nitric Oxide Donors on Uterine and Subendometrial Blood Flow in Patients With Unexplained Infertility

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study to evaluate effect of nitroglycerin trans-dermal patches on uterine and sub-endometrial blood flow in women with unexplained infertility.

Detailed description

90 female patients will be divided into 2 equal groups: * Group I: 30 female patients with unexplained infertility. * Group II: 30 female patients with unexplained infertility will receive nitroglycerin trans-dermal patch. All subjects will be subjected to the following: * Proper history taking on past medical history, menstrual history and infertility workup. * Proper examination (general, abdominal and local examinations) * Investigations to diagnose unexplained infertility ( male partner's semen analysis as well as documented ovulation and a patent uterine cavity and Fallopian tubes in the female partner). * Group II (30 patients with unexplained infertility)will receive: (nitrodermal®) 5 mg (patch)as a source of Nitric oxide from 2nd day of cycle till maturation of the follicles ≥ 18 mm just for one cycle * All women included in each group will be subjected to trans-vaginal ultrasound for folliculometry till maturation of the follicle ≥18mm. * Once the follicle reached ≥18 mm 3D power Doppler will be used to assess the uterine and sub-endometrial blood flow. * All women in each group will be subjected to urinary luteinizing hormone (LH) assay. The urinary LH assay will be started on cycle day 11, and repeated daily till detection of the LH surge. * Six days after detection of the LH surge, 3D power Doppler will be repeated to assess the uterine and sub-endometrial blood flow.

Conditions

• Polycystic Ovary Syndrome
• Infertility, Female

Interventions

Type	Name	Description
DRUG	Nitroglycerin	(nitrodermal®) 5 mg (patch)as a source of Nitric oxide from 2nd day of cycle till maturation of the follicles ≥ 18 mm just for one cycle.
DEVICE	Three dimensional power doppler	Once the follicle reached ≥18 mm 3D power Doppler will be used to assess the uterine and subendometrial blood flow

Timeline

• Start date: 2017-11-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2018-03-29
• Last updated: 2018-03-29

Locations

1 site across 1 country: Egypt