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

March 27, 2018 updated by: Rehab Mohamed Abdelrahman, Ain Shams University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11591
        • Department of obstetrics and gynaecology, faculty of medicine, Ain shams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Age between 20-35 years.6

  2. Normal husband's semen analysis (WHO 2010 Criteria):

    • Count ≥15 million
    • Motility ≥ 32% progressive motility
    • Morphology ≥ 4% normal morphology
  3. Documented ovulation ( basal body temperature , mid-luteal serum progesterone ≥3 ng / ml and ultrasound monitoring of ovulation).
  4. Patent Fallopian tube and excluding uterine anomalies either by hystero-salpingogram (HSG) and/or laparoscopy.
  5. Normal hormonal profile (serum progesterone, E2, F.S.H, LH and T.S.H In the 2ND Day of menstrual cycle)

Exclusion Criteria:

  1. Male factor of infertility.
  2. Patients with uterine pathology as fibroids.
  3. Tubal factor of infertility diagnosed by hysterosalpingography (HSG) or laparoscopy.
  4. Patients with any contraindications for NO such as chronic liver and renal disease, known cardiac disease and migraine.

  5. Diagnosis of PCO based on Rotterdam criteria, two out of three of the following are required to make the diagnosis (Rotterdam, 2004):

    • Oligo- and/or anovulation.
    • Clinical and/or biochemical signs of hyperandrogenism.
    • Polycystic ovaries (by transvaginal ultrasound): the morphology of PCO has been defined as an ovary with 12 or more follicles measuring 2-9 mm in diameter and/or increased ovarian volume (>10 cm3) (Balen et al, 2003).

  6. Conditions that mimic PCOS; disorders that cause oligo/anovulation and/or hyperandrogenism, such as:

    • Thyroid disease.
    • Non classic congenital adrenal hyperplasia.
    • Hyperprolactinemia.
    • Androgen-secreting tumors.
  7. Women who had any medical comorbidity (e.g. autoimmune disease or diabetes mellitus) and those who have been using medications to induce ovulation or medications known to affect the VEGF concentration (NSAIDs) were not included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group without nitroglycerin
They will be subjected to TV ultrasound for folliculometry till maturation of the follicle ≥18mm then Three dimensional power Doppler will be used to assess the uterine and sub-endometrial blood flow.
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
Experimental: Group with nitroglycerin
They will receive (nitrodermal®) 5 mg (patch) from 2nd day of cycle till maturation of the follicles ≥ 18 mm then Three dimensional power Doppler will be used to assess the uterine and sub-endometrial blood flow.
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
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.
Other Names:
  • nitrodermal patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Three dimensional power Doppler
Time Frame: from day 10 of menstrual cycle until the follicle reached ≥18 mm
Once the follicle reached ≥18 mm 3D power Doppler will be used to assess the uterine and sub-endometrial blood flow
from day 10 of menstrual cycle until the follicle reached ≥18 mm

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: 2 weeks after follicle reached ≥18 mm
serum B-HCG titre if the patient suffered from amenorrhea
2 weeks after follicle reached ≥18 mm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

March 19, 2018

First Submitted That Met QC Criteria

March 27, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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