Comparison of Pregnancy Outcomes in Frozen Embryo Transfer in Natural and Hormonal Replacement Cycles: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
This study is a prospective randomized controlled trial to compare the pregnancy outcomes of frozen embryo transfer in natural and hormonal replacement cycles. The study population consisted of all infertile women with regular menstrual cycles who will undergo IVF/ICSI and frozen embryo transfer in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran.
详细描述
In this study all patients who will undergo frozen embryo transfer are randomly allocated to be prepared for transfer by using either natural cycle (with or without hCG for ovulation induction) or Hormonal cycle (with or without administration of GnRH-a) In natural cycle without hCG, daily monitoring of urinary LH is started from day eight of the cycle and frozen-thawed embryo transfer is planned 3-5 days after detection of LH surge, observing mature follicles in ultrasound and endometrial thickness over 7mm for cleavage embryos.
In natural cycle with hCG, after detection of mature follicles in ultrasound and endometrial thickness over 7mm, 10,000IU hCG is injected for ovulation and embryo transfer is performed 3-5 days later in cleavage stage.
In group 3, injection of GnRH agonist (Superfact) at a subcutaneous daily dose of 0.5 mg is started on the day 17-19 of the natural menstrual cycle. Once pituitary desensitization is confirmed, hormonal treatment is commenced with 4mg/day oral Estradiol valerate and after 7 days if endometrial thickness is adequate, Estradiol administration will be continued with the same dose and 100mg Progesterone is administered before embryo transfer, otherwise patients are candidates for higher dosage of Estradiol till favourable endometrial thickness is achieved.
In the hormonal group without GnRH-a, endometrial preparation will be started with daily administration of 6 mg Estradiol valerate from the 2nd day of the natural menstrual cycle for 6 days. Then treatment will be continued similar to the 3rd group.
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
- None
入排标准
- 年龄范围
- 20 Years 至 37 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with regular mensturation cycles
- •Age 20-37 years
- •Patients who underwent long protocol
- •Body mass index (BMI) ≤ 30 kg/m2
- •Patients who will undergo frozen embryo transfer for the first time
排除标准
- •Oocyte or embryo donation cycles
- •Uterine diseases or malformations
- •Hyper prolactinemia
- •Thyroid disorders
- •Tuberculosis
- •Recurrent abortion history
- •Severe endometriosis
- •Ovulation disorders
研究组 & 干预措施
Natural cycle
In natural cycle without hCG, daily monitoring of urinary LH is started from day eight of the cycle and frozen-thawed embryo transfer is planned 3-5 days after detection of LH surge, observing mature follicles in ultrasound and endometrial thickness over 7mm for cleavage embryos.
干预措施: frozen Embryo transfer (Biological)
Natural cycle + hCG for ovulation induction
In natural cycle with hCG, after detection of mature follicles in ultrasound and endometrial thickness over 7mm, 10,000IU hCG is injected for ovulation and embryo transfer is performed 3-5 days later in cleavage stage.
干预措施: frozen Embryo transfer (Biological)
Natural cycle + hCG for ovulation induction
In natural cycle with hCG, after detection of mature follicles in ultrasound and endometrial thickness over 7mm, 10,000IU hCG is injected for ovulation and embryo transfer is performed 3-5 days later in cleavage stage.
干预措施: 10,000U hCG injection (Drug)
Hormonally controlled cycle with GnRH-a
In this group , injection of GnRH agonist (Superfact) at a subcutaneous daily dose of 0.5 mg is started on the day 17-19 of the natural menstrual cycle. Once pituitary desensitization is confirmed, hormonal treatment is commenced with 4mg/day oral Estradiol valerate and after 7 days if endometrial thickness is adequate, Estradiol administration will be continued with the same dose and 100mg Progesterone is administered before embryo transfer, otherwise patients are candidates for higher dosage of Estradiol till favourable endometrial thickness is achieved.
干预措施: frozen Embryo transfer (Biological)
Hormonally controlled cycle with GnRH-a
In this group , injection of GnRH agonist (Superfact) at a subcutaneous daily dose of 0.5 mg is started on the day 17-19 of the natural menstrual cycle. Once pituitary desensitization is confirmed, hormonal treatment is commenced with 4mg/day oral Estradiol valerate and after 7 days if endometrial thickness is adequate, Estradiol administration will be continued with the same dose and 100mg Progesterone is administered before embryo transfer, otherwise patients are candidates for higher dosage of Estradiol till favourable endometrial thickness is achieved.
干预措施: GnRH agonist (Superfact) (Drug)
Hormonally controlled cycle without GnRH-a
In the hormonal group without GnRH-a, endometrial preparation will be started with daily administration of 6 mg Estradiol valerate from the 2nd day of the natural menstrual cycle for 6 days. Then treatment will be continued similar to the 3rd group.
干预措施: frozen Embryo transfer (Biological)
Hormonally controlled cycle without GnRH-a
In the hormonal group without GnRH-a, endometrial preparation will be started with daily administration of 6 mg Estradiol valerate from the 2nd day of the natural menstrual cycle for 6 days. Then treatment will be continued similar to the 3rd group.
干预措施: administration of 6 mg Estradiol valerate (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: 4 weeks
The pregnancy rate will be evaluated in patients of each groups 4-6 weeks after embryo transfer.
次要结局
- miscarriage rate(12 weeks)
- Implantation rate(4 weeks)
- chemical pregnancy rates(2 weeks)
- Ongoing pregnancy(12 weeks)