Effectiveness of Progestin-Primed Ovarian Stimulation Versus GnRH Antagonist Protocol for Ovarian Stimulation in IVF: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 626
- 试验地点
- 2
- 主要终点
- Ongoing pregnancy
研究概览
简要总结
This non-inferiority randomized controlled trial will be conducted at My Duc Hospital, Ho Chi Minh City, Vietnam.
This study compares the effectiveness of Progestin-Primed Ovarian stimulation versus GnRH protocol for ovarian stimulation in IVF treatment. Participants will be randomly assigned in a 1:1 ratio to receive Progestins or GnRH antagonists.
详细描述
Study Procedures
Participants will be randomized into two arms:
- PPOS group: Recombinant FSH 150-300 IU/day will start from day 2 to day 4 of menstruation. The initial FSH dose will be chosen based on age, anti-Müllerian hormone (AMH) level, antral follicle count (AFC), and body mass index (BMI). The FSH dosage will be fixed during ovarian stimulation. Dydrogesterone (Duphaston, Abbott, USA) 20mg/day will start on the day of gonadotropin injection to the oocyte maturation trigger night.
- GnRH antagonist group: Recombinant FSH 150-300 IU/day will be given from day 2 to day 4 of menstruation. The initial FSH dose will be chosen based on age, anti-Müllerian hormone (AMH) level, antral follicle count (AFC), and body mass index (BMI). The FSH dosage will be fixed during ovarian stimulation. Cetrorelix (Cetrotide, Merck, Germany) 0.25mg/day will be given from day 5 of stimulation by the oocyte maturation trigger day.
Follicular monitoring will start on the fifth or sixth day of ovarian stimulation and was performed every 3-5 days thereafter using transvaginal ultrasound to record the number of developing follicles. Measuring LH, estradiol, and progesterone serum levels will be performed on the fifth or sixth day of ovarian stimulation and oocyte maturation day (before the trigger injection). The FSH dosage will be fixed during ovarian stimulation. When more than two dominant follicles reach a diameter of at least 17mm, >= 50% diameter of remaining follicles cohort >=12 mm, the final stage of oocyte maturation will trigger using human chorionic gonadotropin (hCG; IVF-C 10.000 IU, LG Chem, Ltd., Korea or Ovitrelle Pen 250µg, Merck Serono S.p.A., Italy). In individuals who are at high risk for OHSS, GnRH agonist trigger 0.2mg (Diphereline 0.2mg, Ipsen Pharma, France) will given subcutaneously.
Transvaginal ultrasound-guided oocyte retrieval will be performed 34-36 hours after trigger, with the retrieval of all follicles exceeding 10mm in diameter. Oocyte fertilization will be carried out in vitro using ICSI. On the third day after fertilization, embryos will be evaluated for the degree of embryonic fragmentation, regularity, and number of blastomeres in accordance with the Istanbul consensus (Alpha Scientists in Reproductive Medicine and ESHRE Special Interest Group of Embryology, 2011). Day 3 embryos will be cryopreserved or cultured until the blastocyst stage based on physician recommendation or patient references; viable blastocysts will then be cryopreserved on day 5 or day 6.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman aged 18-40
- •BMI ≤ 25kg/m2
- •AMH > 1.2ng/mL or AFC >5
- •Having indication for IVF treatment
- •Agree to have frozen embryo(s) transfer
- •Not participating in any other clinical trials
- •Provision of written informed consent to participate
排除标准
- •Undergoing IVF cycle with other protocols: Down-regulation, mild stimulation, Random start
- •Oocyte donation cycles
- •Undergoing vitrified oocyte accumulation
- •Oocyte cryopreservation
- •Cycle with PGT (Preimplatation genetic testing)
- •Women with PCOS
- •Women allergy to dydrogesterone, rFSH, GnRH antagonist
研究组 & 干预措施
Progestins Primed Ovarian stimulation group
PPOS group: Recombinant FSH 150-300 IU/day will start from day 2 to day 4 of menstruation. The initial FSH dose will be chosen based on age, anti-Müllerian hormone (AMH) level, antral follicle count (AFC), and body mass index (BMI). The FSH dosage will be fixed during ovarian stimulation. Dydrogesterone (Duphaston, Abbott, USA) 20mg/day will start on the day of gonadotropin injection to the oocyte maturation trigger night.
干预措施: Dydrogesterone 10 mg (Drug)
GnRH antagonist group
GnRH antagonist group: Recombinant FSH 150-300 IU/day will be given from day 2 to day 4 of menstruation. The initial FSH dose will be chosen based on age, anti-Müllerian hormone (AMH) level, antral follicle count (AFC), and body mass index (BMI). The FSH dosage will be fixed during ovarian stimulation. Cetrorelix (Cetrotide, Merck, Germany) 0.25mg/day will be given from day 5 of stimulation by the oocyte maturation trigger day.
干预措施: Cetrorelix 0.25 mg (Drug)
结局指标
主要结局
Ongoing pregnancy
时间窗: At 10 weeks after embryo(s) placement
defined as pregnancy with a detectable heart rate at 12 weeks gestation or beyond
次要结局
- The incidence of premature LH surge(On the day having indication of oocyte maturation)
- Number of day 3 embryos(At 62-66 hours after ICSI)
- Number of day 5 embryos(At 112-116 hours after ICSI)
- Number of good quality day 3 embryos(At 62-66 hours after ICSI)
- Number of good quality day 5 embryos(At 112-116 hours after ICSI)
- Number of frozen embryos(at 112-116 hours after ICSI)
- Incidence of Ovarian hyperstimulation syndrome(At 2 weeks after trigger)
- Positive ß-hCG test(At 2 weeks after embryo(s) placement)
- Clinical pregnancy(at 6 weeks or more after the onset of last menstrual period)
- Ectopic pregnancy(at 6 weeks after the onset of last menstrual period)
- Early miscarriage <12 weeks(At 12 weeks of gestation)
- Late miscariage 12-< 22 weeks(between 12 to 22 completed weeks of gestational age)
- Live birth rate(At 22 weeks of gestation)
- Gestational age at birth(At birth)
- Mode of delivery(At birth)
- Birth weight(At birth)
- Very low birth weight(At birth)
- Low birth weight(At birth)
- High birth weight(At birth)
- Very high birth weight(At birth)
- Preterm birth(At birth)
- Gestational diabetes mellitus(At 24 to 28 weeks of gestation)
- Hypertensive disorders of pregnancy(At 20 weeks of gestation or beyond)
- Maternal mortality(From randomization to within 42 days of termination of pregnancy)
- Major congenital abnormalities(From randomization to delivery)
- NICU admission(at birth)
- Reason for NICU admission(at birth)
- Neonatal mortality(within 28 days of birth)
- The incidence of premature progesterone elevation(On the day having indication of oocyte maturation)
- Number of oocytes retrieved(On the oocyte(s) retrieval day)
- Number of mature oocytes(On the oocyte(s) retrieval day)