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

NCT03481582 | Completed DMC

• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polycystic Ovary Syndrome; Infertility, Female

Keywords

Nitroglycerin Trans-dermal Patch

Outcome Measures

Primary Outcomes (1)

• Three dimensional power Doppler

  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 Outcomes (1)

• Pregnancy rate

  2 weeks after follicle reached ≥18 mm

Study Arms (2)

Group without nitroglycerin

ACTIVE COMPARATOR

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

Group with nitroglycerin

EXPERIMENTAL

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.

Drug: Nitroglycerin; Device: Three dimensional power doppler

Interventions

Nitroglycerin DRUG

(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.

Also known as: nitrodermal patch

Group with nitroglycerin

Three dimensional power doppler DEVICE

Once the follicle reached ≥18 mm 3D power Doppler will be used to assess the uterine and subendometrial blood flow

Group with nitroglycerin; Group without nitroglycerin

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 20-35 years.6
• Normal husband's semen analysis (WHO 2010 Criteria):
• Count ≥15 million
• Motility ≥ 32% progressive motility
• Morphology ≥ 4% normal morphology
• Documented ovulation ( basal body temperature , mid-luteal serum progesterone ≥3 ng / ml and ultrasound monitoring of ovulation).
• Patent Fallopian tube and excluding uterine anomalies either by hystero-salpingogram (HSG) and/or laparoscopy.
• Normal hormonal profile (serum progesterone, E2, F.S.H, LH and T.S.H In the 2ND Day of menstrual cycle)

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Department of obstetrics and gynaecology, faculty of medicine, Ain shams university

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility, Female

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Infertility

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: * After enrollment, participants would be given the next available number in a computer generated randomization plan . * Allocation concealment (among unexplained infertile groups): Opaque, serially-numbered, sealed envelopes will enclose the letter corresponding to the group the patient will follow. Envelopes will be opened when the patient is enrolled and she will receive the intervention accordingly. -Blinding The study design precludes neither participant nor the doctor will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of obstetric and gynaecology

Model Details: 90 female patients will be divided into 3 equal groups: * Group I: 30 female patients with unexplained infertility. * Group II: 30 female patients with unexplained infertility will receive nitroglycerin trans-dermal patch.

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: March 29, 2018
• Study Start: November 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

EG (1)