Effect of Nitric Oxide Donors on Uterine and Subendometrial Blood Flow in Patients With Unexplained Infertility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Three dimensional power Doppler
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
- 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.
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Three dimensional power doppler (Device)
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.
干预措施: Nitroglycerin (Drug)
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.
干预措施: Three dimensional power doppler (Device)
结局指标
主要结局
Three dimensional power Doppler
时间窗: 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
次要结局
- Pregnancy rate(2 weeks after follicle reached ≥18 mm)
研究者
Rehab Mohamed Abdelrahman
lecturer of obstetric and gynaecology
Ain Shams University