Clinical trial · Interventional
Effect of Nitric Oxide Donors on Uterine and Subendometrial Blood Flow in Patients With Unexplained Infertility
NCT03481582CI-TRIAL-00032272completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infertility, Female | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nitroglycerin | Drug | — | UNRESOLVED |
| Three dimensional power doppler | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group without nitroglycerin
- description
- 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.
- interventionNames
- Device: Three dimensional power doppler
- type
- EXPERIMENTAL
- label
- Group with nitroglycerin
- description
- 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.
- interventionNames
- Drug: Nitroglycerin
- Device: Three dimensional power doppler
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 35 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.