The Efficiency of Non-FSH Versus FSH-priming in CAPA-IVM Cycles: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of matured oocytes after CAPA-IVM cultured
研究概览
简要总结
In vitro oocyte maturation (IVM) is an assisted reproductive technology requiring minimal or no ovarian stimulation. In this technique, the immature oocytes were retrieved from follicles and subsequently cultured matured, meaning that GV oocytes reached MII in vitro (ASRM, 2021).
Currently, there is no consensus on the unique IVM protocol. However, recommended protocols that are being utilized include IVM with and without hCG (Standard IVM) and CAPA-IVM.
As mentioned previously, FSH priming before oocyte retrieval for IVM remains controversial. However, FSH is known as a hormone for the maturation of the follicles. Therefore, during oocyte maturation (IVM) cycles, FSH is used to "prime" follicular development. Generally, many studies showed a trend of a higher number of MII oocytes obtained after IVM after using FSH priming.
In animal models, Younis et al. (1994) observed a significant increase in the number of mature oocytes when performing IVM in cynomolgus monkeys (Macaca fascicularis) with a dose of 1000 IU of PMSG (pregnant mare's serum gonadotropin) in the follicular phase (Younis et al., 1994). Similarly, Wynn et al. (1998) conducted a study on mice. The results from this study revealed that a higher number of MII oocytes was observed. Still, the blastulation rate and the number of blastomeres were significantly lower than that without FSH priming. On the other hand, FSH activates meiosis resumption (Wynn et al., 1998).
In addition, an RCT of 28 patients comparing three days of 150 IU of FSH before the IVM aspiration group with the control group also showed an improvement in implantation rates in IVM cycles with FSH priming (Mikkelsen et al., 2001). The studies mentioned above both used the non-hCG IVM protocol. Other studies by Shalom-Paz et al. (2011) and Choavaratana et al. (2015) showed superiority in the number of MII oocytes.
There has been no data on the impact of not using FSH priming in CAPA-IVM cycles. Therefore, this RCT will investigate the efficacy of CAPA-IVM with and without FSH priming.
详细描述
3.1. Screening for eligibility and randomization
- This trial will be conducted at My Duc Hospital, Ho Chi Minh City, Viet Nam.
- Women who are potentially eligible will be provided information about the trial at the time of IVM treatment indication.
- Screening for eligibility will be performed on the day of the first visit when the IVM treatment is indicated.
- Patients will be provided information related to the study together with the informed consent documents. Signed informed consent forms will be obtained by the investigators from all women before the enrolment.
- All patients selected for this study will undergo a 7-day COCPs administration to induce menstruation before entering both arms.
- Women will be randomized (1:1) to either non-FSH or FSH priming:
3.2 Oocytes retrieval The oocyte retrieval will be performed four days after the randomization, accordingly to the current routine procedures.
- An ultrasound scan will be performed to exclude the development of any dominant follicle.
- Patients randomized into the FSH priming arm will receive two days of FSH injections at 150 IU/day.
- Oocyte retrieval will be scheduled 42 hours after the last FSH injection.
- In the non-FSH arm, the COC will be retrieved on the same retrieval day as the FSH-treated arm.
- All the punctured follicular cohorts will be monitored carefully by ultrasound on the day before and on OPU day.
3.3 CAPA and Maturation culture: CAPA and Maturation culture will be performed routinely following current laboratory protocols.
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
- Single (Investigator)
盲法说明
Embryologists are blinded to individual clinical treatment allocation
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aging from 18 to 37
- •Diagnosed with PCOS followed by Rotterdam criteria
- •Having an indication for CAPA-IVM treatment
- •Agree to have all embryos frozen on day 5/
- •Agree to have one blastocyst (if of good quality defined as 3BB or above) or up to two blastocysts (if no good quality are available) transferred in a subsequent frozen transfer
- •Having ≤ 2 IVM/IVF attempts
排除标准
- •A previous ovarian stimulation (for OI or IVF) within the previous three months
- •Cycles with oocytes donation
- •Uterine or ovarian abnormalities
- •Previous evidence of a very low oocyte maturation without suspicion of FSH /LH receptor defect
- •Cycles with sperms retrieved after PESA/TESE/microTESE
研究组 & 干预措施
non-FSH priming
Routine CAPA-IVM treatment will be performed. The oocyte retrieval will be performed 2 days after the randomization accordingly to the current routine procedures. An ultrasound scan will be performed to exclude the development of any dominant follicle.
FSH priming
Routine CAPA-IVM treatment will be performed. Patients who are randomized into the FSH priming arm will receive two days of FSH injections of 150 IU/day. Oocyte retrieval will be scheduled at 42 hours after the last FSH injection.
干预措施: FSH priming (Procedure)
结局指标
主要结局
Number of matured oocytes after CAPA-IVM cultured
时间窗: 2 day after oocyte retrieval
Number of oocytes at MII stage after CAPA-IVM cultured
次要结局
- Implantation rate(3 weeks after embryo transfer)
- Ectopic pregnancy rate(4 weeks after embryo transfer)
- Ongoing pregnancy rate(10 weeks after embryo transfer)
- Live birth rate(After delivery at 12 months after randomization)
- Miscarriage rate(2-10 weeks after embryo transfer)
- Multiple pregnancy rate(5 weeks after embryo transfer)
- Clinical pregnancy rate(5 weeks after embryo transfer)
- Small for gestational age(After delivery at 12 months after randomization)
- Admission to NICU(After delivery at 12 months after randomization)
- Positive pregnancy test rate(2 weeks after embryo transfer)
- Birth weight(At delivery at 12 months after randomization)
- Gestational diabetes mellitus(At 24 weeks of gestation or beyond at 12 months after randomization)
- Hypertensive disorders of pregnancy(At 20 weeks of gestation or beyond at 12 months after randomization)
- Antepartum hemorrhage(After delivery at 12 months after randomization)
- Congenital anomaly(After delivery at 12 months after randomization)
- Preterm delivery rate(At delivery at 12 months after randomization)
- Large for gestational age(After delivery at 12 months after randomization)
- Perinatal mortality(After delivery at 12 months after randomization)