Prospective, Randomised, Double-blind, Placebo Controlled, Phase III Clinical Study Assessing the Efficacy of 25 mg Natural Progesterone Administered Subcutaneously in Restoring the Normal Luteal Phase in Women With Previous Diagnosis of Luteal Phase Deficiency
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Ongoing pregnancy rate at 12 weeks of gestation
研究概览
简要总结
The main objective of this study will be to assess the efficacy of natural progesterone at a daily dose of 25 mg in restoring a normal luteal phase. The primary end-point will be the ongoing pregnancy rate.
The secondary objectives will be the rate of endometrial biopsy showing an in phase endometrium after 3 months of treatment.
The length of the luteal phase of the menstrual cycle after treatment will also be assessed and compared with the initial duration (from LH peak to onset of menstruation).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who wish to get pregnant with a previous diagnosis of luteal phase deficiency:
- •Able and willing to sign the Subject Consent Form and adhere to the study visit schedule;
- •Age: 20-35 years;
- •BMI: 18-28 kg/m2;
- •Inadequate luteal phase (menstrual period shorter than 21 days);
- •Sub-fertile couple: 12 months of trying to conceive without success.
- •Normal uterine cavity;
- •Basal P4 level (day 3 of a previous cycle) ≤ 3ng/ml;
- •Non-smoking;
- •Fertile male partner (normal sperm count).
排除标准
- •History of recurrent miscarriage;
- •Basal P4 level (day 3 of a previous cycle) > 3ng/ml;
- •Severe uterine malformations (including submucosal fibroids, endometrial polyps, and intrauterine adhesions) ;
- •Known hypersensitivity to study medication;
- •Neoplasias (known or suspected breast or genital tract cancer);
- •Severe impairment of hepatic or renal function;
- •Use of concomitant medications that might interfere with study evaluations (other hormonal treatment);
- •Current vaginal infection;
- •Endometriosis;
- •Partially or completed block of fallopian tubes;
- •Hydrosalpinx;
- •Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events;
- •Porphyria;
- •A history of idiopathic jaundice, severe pruritus or pemphigoid gestationis during pregnancy;
- •Antiphospholipid syndrome;
- •Diabetes mellitus;
- •Thyroid diseases or autoimmune conditions;
- •Hypothalamic dysfunction;
- •Hyperprolactinaemia;
- •Infertility due to male factor;
研究组 & 干预措施
Progesterone
25 mg of progesterone will be administered daily by subcutaneous injection.
干预措施: Progesterone (Drug)
Placebo
25 mg of progesterone will be administered daily by subcutaneous injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Ongoing pregnancy rate at 12 weeks of gestation
时间窗: 12 weeks
次要结局
- Rate of in phase endometrial biopsies(3 months)
- Length of luteal phase(3 months)