CTRI/2009/091/000086未知4 期
A Prospective, Multicentric, Randomized, Comparative, Open Label, Parallel Group Phase IV Study To Evaluate The Efficacy, Safety And Cost Effectiveness Of Minimal Stimulation Protocol Compared To Standard Stimulation Protocol For In vitro Fertilization In Indian Population
Indian Society of Assisted Reproduction ISAR23 个研究点 分布在 1 个国家目标入组 210 人开始时间: 待定
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 210
- 试验地点
- 23
- 主要终点
- 1. Mean percentage of grade 1 oocytes retrieved 2. Mean percentage of fertilization rate
研究概览
简要总结
This study is a randomised open label multi-centre trial to compare the efficacy and safety of the Minimal stimulation protocol vis-a-vis the standard protocol for artificial reproduction (using ICSI) with rFSH (Foligraf), manufactured by Bharat Serums and Vaccines Ltd. The study is being conducted at 24 centres in India. Thr primary outcome is number of grade 1 oocytes and mean percentage of fertilisation rate. The secondary outcomes are percentage of clinical pregnancy, mean dose of rFSH and incidence of AEs.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 37.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Women in the age group of 18 37 years (both inclusive) with normal ovulatory cycles 2.Women with body mass index (BMI) between 20 and 30 kg/m2 3.Women with primary or secondary Infertility 4.Women with negative urine pregnancy test (UPT) 5.Women with normal or clinically insignificant hematology and blood chemistry values.
- •6.Women whose male partner does not require surgical sperm retrieval [Percutaneous epididymal sperm aspiration (PESA) or Testicular epididymal sperm aspiration (TESA)].
- •7.Women with FSH, LH, Estradiol (E2),Progesterone (P4) at luteal phase, and Prolactin levels within normal range 8.Women with both intact ovaries.
- •Transvaginal ultrasound documenting the presence of both ovaries, without evidence of abnormality (e.g. no endometrioma) and normal adnexa (e.g. no hydrosalpinx) within 6 months before randomization 9.Male with normal sperm motility and sperm count more than 4 million/mL.
排除标准
- •Women with gonadal failure or premature ovarian failure
- •Women with FSH >10 IU/L
- •Women with thyroid or adrenal dysfunction
- •Women with PCOS, endometrioma (endometrial thickness >4mm) or any other active pelvic pathology
- •Women with untreated fibroid tumors of the uterus of <4 cm in size (incompatible with pregnancy), including untreated submucous myoma and 12 weeks adenomyomas
- •Women with >3 previously unsuccessful IVF cycles or previous IVF cycle with unsuccessful fertilization
- •Women with history of recurrent miscarriage
- •Women with tumors of the ovary, breast, uterus, pituitary or hypothalamus and malformations of the sexual organs (incompatible with pregnancy)
- •Women with history of diabetes or hypertension or any other systemic disorder and on treatment for the same
- •Women with history of hypersensitivity to any excipients of the investigational products
- •Women who have participated in another study or received any investigational product 30 days prior to enrolment or simultaneous participation in another clinical study
- •Women who are poor responders to FSH
- •Women with complete or partial hysterectomy.
结局指标
主要结局
1. Mean percentage of grade 1 oocytes retrieved 2. Mean percentage of fertilization rate
时间窗: 4 weeks
次要结局
- 1. Mean total dose in IU required to achieve follicle size ≥18 mm in diameter (from the day of r-hFSH administration to the Day of Human Chorionic Gonadotropin [HCG] administration)2. Percentage of Clinical Pregnancy rate3. Number of mature and immature oocytes4. Ratio of mature and immature oocytes5. Number of grade I embryos6. Percentage of Chemical Pregnancy rate7. Mean days of stimulation with r-hFSH required to achieve follicle size ≥18 mm in diameter 8. Risk of OHSS 9. Incidence & Absolute Frequency of AE?s reported in the trial which were related to study drugs administered in Group A & Group B(4 weeks)
研究者
研究点 (23)
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