The Impact of Using Platelet-Rich Plasma Versus Granulocyte Colony-Stimulating Factor Versus Placebo on the Outcomes of Frozen Embryo Transfer: A Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 665
- 试验地点
- 1
- 主要终点
- The clinical pregnancy rate
研究概览
简要总结
The goal of this clinical trial is to assess the impact of using Platelet-Rich Plasma (PRP) vs. Granulocyte Colony-Stimulating Factor (GCSF) vs. placebo on the outcomes of frozen embryo transfer (FET) in terms of clinical pregnancy rates. It will also assess their effect on chemical pregnancy rate, implantation rate, delivery outcomes, and endometrial parameters.
The main questions it aims to answer are:
Do the clinical pregnancy rates differ upon using PRP vs. GCSF vs. placebo during FET? What are the effects of PRP vs. GCSF vs. placebo during FET on chemical pregnancy rate, implantation rate, delivery outcomes, and endometrial parameters?
Researchers will compare the effect of administration of PRP vs. GCSF vs. placebo during FET on pregnancy outcomes.
Participants will be randomized to receive the study intervention seven days before embryo transfer: 1.0 ml of either PRP (prepared in-house), GCSF (Filgrastim, 300 mcg/1.0 mL), or 0.9% saline (placebo). The intervention will be administered by slow infusion into the uterine cavity with an intrauterine insemination catheter.
详细描述
INTRODUCTION AND STUDY RATIONALE Despite the advancements in the treatment of infertility, repeated failure of implantation continues as a challenging difficulty.
Embryo implantation is affected by many factors. Many efforts were made to improve the implantation rate by different methods blastocyst transfer, assisted hatching, preimplantation genetic screening, hysteroscopy, removal of hydrosalpinges and endometrial scratch. Furthermore, infertility specialists suggested some empirical methods like the infusion in the uterine cavity of platelet-rich plasma (PRP) in patients with thin endometrium which has been shown to be effective in improving the pregnancy rate.
Another factor is granulocyte colony stimulating factor (GCSF) which has receptors in endometrial cells and may have a role in implantation. The use of GCSF in assisted reproductive technology (ART) has been tried by many research studies either via intrauterine or systemic administration.
There are limited studies that compared the impact of PRP and GCSF administration on the pregnancy rate and on the endometrial thickness with a small sample size.
The rationale behind this current study is to assess the impact of using PRP versus GCSF versus on the outcomes of FET in terms of pregnancy rates.
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, Investigator)
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
- •All women aged 20-40 years
- •Non-smoker
- •BMI < 30
- •Normal endometrial cavity confirmed by hysteroscopy and ultrasound
- •Visiting the center for IVF by FET during the period of the study
排除标准
- •History of anti-phospholipid syndrome confirmed by serological tests.
- •History of any hematological and immunological disorders
- •History of chromosomal or genetic abnormalities in the patient or in the family
- •Any uterine abnormalities (congenital or acquired)
- •Previous uterine surgeries except caesarean section
- •Hypersensitivity to G-CSF
- •Uncontrolled systemic disease
研究组 & 干预措施
Granulocyte Colony Stimulating Factor Arm
Women in this group will receive GCSF with conventional hormonal therapy:
Estradiol valerate 6mg/day from day 2 of menstrual cycle Vaginal sildenafil citrate 25mg / 6 hours Then frozen embryo transfer will be performed.
干预措施: Granulocyte Colony Stimulating Factor (Drug)
Platelet Rich Plasma Arm
Women in this group will receive PRP with conventional hormonal therapy:
Estradiol valerate 6mg/day from day 2 of menstrual cycle Vaginal sildenafil citrate 25mg / 6 hours Then frozen embryo transfer will be performed.
干预措施: Platelet Rich Plasma Arm (Other)
Saline
Women in this group will receive saline with conventional hormonal therapy:
Estradiol valerate 6mg/day from day 2 of menstrual cycle Vaginal sildenafil citrate 25mg / 6 hours Then frozen embryo transfer will be performed.
干预措施: Saline (Other)
结局指标
主要结局
The clinical pregnancy rate
时间窗: 6 to 8 weeks of embryo transfer
Definition: The presence of fetal heartbeats in transvaginal ultrasound after 6 to 8 weeks of embryo transfer in all groups. Unit of Measure: The percentage of participants who will achieve a clinical pregnancy among those who underwent the embryo transfer, calculated by dividing the number of participants who will have a clinical pregnancy by the total number of participants who underwent embryo transfer and multiplying by 100.
次要结局
- Endometrial Thickness(The changes in endometrial parameters between the intervention cycle and the natural cycle will be measured during the mid-luteal phase (during 18-23 days of the cycle).)
- Uterine Artery Doppler Indices (e.g., PI, RI)(The changes in endometrial parameters between the intervention cycle and the natural cycle will be measured during the mid-luteal phase (during 18-23 days of the cycle).)
- Histogram Indices (Blood flow velocities)(The changes in endometrial parameters between the intervention cycle and the natural cycle will be measured during the mid-luteal phase (during 18-23 days of the cycle).)
- Histological Dating of Endometrium(The changes in endometrial parameters between the intervention cycle and the natural cycle will be measured during the mid-luteal phase (during 18-23 days of the cycle).)
- Chemical pregnancy rate(2 weeks post embryo transfer)
- Miscarriage rate(20 weeks of gestation)
- Live-birth rate(The live birth rate is assessed at the time of birth, including both full-term and preterm live births.)
- Implantation rate(Between 3 and 5 weeks after embryo transfer.)
- Endometrial Vascularization(The changes in endometrial parameters between the intervention cycle and the natural cycle will be measured during the mid-luteal phase (during 18-23 days of the cycle).)
- Histogram Indices (cell sizes)(The changes in endometrial parameters between the intervention cycle and the natural cycle will be measured during the mid-luteal phase (during 18-23 days of the cycle).)