Effect of Granulocyte Colony-stimulating Factor on Clinical Pregnancy Rate in Patients With Endometriosis Undergoing In-vitro Fertilization After Recurrent Implantation Failure
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 88
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
The aim of this study is to evaluate the effect of granulocyte colony-stimulating factor on clinical pregnancy rate in patients with endometriosis undergoing in-vitro fertilization after recurrent implantation failure.
详细描述
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Type of Study: A randomized double-blind controlled trial.
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Study Setting: IVF unit in Maternity Hospital of Ain Shams University.
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Study Population: A total of 88 women with endometriosis will be enrolled in the study divided into two groups:
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Group A (N=44): women will receive intrauterine infusion of G-CSF on the day of ovum-pick up during IVF cycle.
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Group B (N=44): women will receive placebo intrauterine infusion of saline on the day of ovum-pick up during IVF cycle.
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Allocation and Concealment: Eighty eight envelopes will be numbered serially and in each envelope the corresponding letter which denotes the allocated group will be put according to randomization table. When the first patient arrives, the first envelope will be opened and the patient will be allocated according to the letter inside
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Randomization Table:
SN Group SN Group SN Group SN Group SN Group SN Group SN Group SN Group
- A 12 A 23 B 34 B 45 A 56 A 67 B 78 B
- B 13 A 24 A 35 B 46 A 57 A 68 B 79 A
- B 14 A 25 B 36 A 47 B 58 B 69 B 80 A
- B 15 A 26 A 37 A 48 B 59 B 70 A 81 B
- A 16 A 27 B 38 B 49 B 60 B 71 B 82 A
- A 17 A 28 A 39 B 50 B 61 A 72 B 83 B
- A 18 B 29 B 40 B 51 A 62 B 73 A 84 B
- B 19 B 30 A 41 A 52 A 63 A 74 B 85 B
- A 20 A 31 A 42 B 53 A 64 B 75 A 86 B
- A 21 B 32 A 43 A 54 B 65 B 76 B 87 A
- A 22 B 33 B 44 A 55 A 66 B 77 A 88 A
- Sample Size: 88 patients, 44 in group A (the cases) and 44 in group B (the controls).
- Sample Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
: Eighty eight envelopes will be numbered serially and in each envelope the corresponding letter which denotes the allocated group will be put according to randomization table. When the first patient arrives, the first envelope will be opened and the patient will be allocated according to the letter inside into group A or B
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cases of infertility, older than 20 years of age and not older than 40 years.
- •Body mass index (BMI): 20-
- •Women diagnosed with endometriosis (diagnosis based on ultrasound or laparoscopy or both)
- •Recurrent implantation failure (failure to conceive following two embryo transfer cycles, or cummulative transfer of >10 good quality embryos)
- •Normal ovulatory cycles (as proven by folliculometry and/or mid luteal serum progesterone), good ovarian reserve (as proven by early follicular FSH and AMH)
- •Normal uterine cavity as assessed by ultrasonography, hysterosalpingography, or hysteroscopy
- •Normal hormonal profile (serum PRL, TSH, thyroid hormone)
- •Normal semen analysis of the partner
- •Infertility after one year of unprotected intercourse
- •High-quality embryos were transplanted
排除标准
- •Congenital or acquired uterine abnormalities (e.g. septate, bicornuate, fibroid uterus, uterine polyp & Asherman Syndrome)
- •Congenital or acquired tubal abnormalities (e.g. hydrosalpinx or pyosalpinx)
- •Contraindication for G-CSF (renal disease, sickle cell disease, or malignancy history, upper respiratory tract infection, pneumonia, or chronic neutropenia)
- •Thrombophilia
研究组 & 干预措施
Group A
Group A (N=44): women will receive intrauterine infusion of granulocyte colony-stimulating factor on the day of ovum-pick up during IVF cycle.
干预措施: Granulocyte Colony-Stimulating Factor (Drug)
Group B
Group B (N=44): women will receive placebo intrauterine infusion of normal saline on the day of ovum-pick up during IVF cycle.
干预措施: Intrauterine infusion of normal saline (Procedure)
结局指标
主要结局
Clinical pregnancy rate
时间窗: 5-6 weeks from the day of embryo transfer
The primary outcome measure is the clinical pregnancy rate defined as the observation of gestational sac on transvaginal ultrasound examination three weeks after positive serum βhCG.
次要结局
- Miscarriage rate(Before 20 weeks of pregnancy)
- Ongoing pregnancy rate(12 weeks of pregnancy)
- Chemical pregnancy rate(12 days after embryo transfer)
- Implantation rate(6 weeks after embryo transfer)
研究者
Amira Magdi Guergues Selim
Resident of obstetrics and gynecology
Ain Shams Maternity Hospital