CTRI/2024/12/078124尚未招募不适用
A Prospective observational study of oral natural micronized progesterone sustained release formulation as luteal phase support
Alembic Pharmaceuticals Ltd1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年12月24日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Serum Progesterone(P)levels(ng/ml)
研究概览
简要总结
A prospective observational study of oral natural micronized progesterone sustained release formulation as luteal phase support to assess serum progesterone concentration on day 0 of intra-uterine
insemination or following ovulation induction and day 5 in patients who received luteal phase support with oral micronized progesterone sustained release 400 mg tablet.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Woman ready to give informed consent for participation in study.
排除标准
- •Women with history of Progesterone (Natural or synthetic) use in the last 3 months b.
- •History of tubal insufficiency or obstruction including Endometriosis or Polycystic Ovarian Syndrome, c.
- •History of AST and, or ALT greater than 2.5 x ULN (active liver disease), d.
- •History of Serum creatinine greater than 1.5 mg per dl (active renal disease), e.
- •History of Uncontrolled hypertension, hypercholesterolemia or diabetes, f.
- •History of Psychoactive disease or on antidepressants, g.
- •History of Smoking h.
- •History of Myocardial infarction, stroke, cardiovascular or circulatory or clotting disorders i.
- •History of Oral anticoagulants or prolonged use of high doses of NSAIDs, j.
- •Hypersensitivity to Natural micronized progesterone k.
- •Any condition that, in the opinion of the investigator, does not justify the patient’s inclusion in the study.
结局指标
主要结局
Serum Progesterone(P)levels(ng/ml)
时间窗: Day 0 and Day 5
次要结局
- NA(NA)
研究者
Dr Sunita Chandra
Rajendra Nagar Hospital and IVF center
研究点 (1)
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