Progestin Priming Ovarian Stimulation (PPOS) Compared With Antagonist Protocol on Live Birth Rate for Freeze-all Cycles: Recruitment is Slow Due to COVID19
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 3
- 主要终点
- Live Birth after first Vitrified-warmed cycle
研究概览
简要总结
Stimulation protocols for IVF underwent several cycles of upgrading aiming to achieve reasonable outcomes with low-cost cycles. Antagonist protocols have been introduced as effective and comparable to long agonist regarding the outcomes. However, these protocols are still costly. Alternative protocols using progestin suppressions appear options for consideration.
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 (Investigator, Outcomes Assessor)
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
- •Women age of ≥ 18 to ≤ 40;
- •BMI of ≤ 31;
- •All indication for freeze-all
- •Women who have ≥ 1 year of primary or secondary infertility;
- •Tubal factor (unilateral, bilateral obstruction or salpingectomy);
- •Fresh ejaculate sperm of any count provided they have ≥ 1% normal forms and a motile fraction;
- •Women undergoing their first ICSI cycle or following a previous successful attempt;
- •Women undergoing only frozen-thawed embryo transfer;
- •Women with > 8 mm endometrial thickness at the day of progesterone supplementation in the transfer cycle;
- •Women with no detected uterine abnormality on transvaginal ultrasound (e.g. submucosal myomas, polyps or septa).
排除标准
- •Unilateral oophorectomy;
- •Uterine pathology or abnormality;
- •Abnormal karyotyping for them or their male partners;
- •History of repeated abortions or implantation failure;
- •Uncontrolled diabetes;
- •Liver or renal disease;
- •History of malignancy or borderline pathology;
- •Endometriosis;
- •Plan for PGD-A;
- •Severe male factor includes surgical sperm retrieval or cryopreserved sperm.
研究组 & 干预措施
Antagonist Suppression
cetrorelix acetate 0.25 started on stimulation day 6 till the trigger day to prevent LH surge. The stimulation is with150-300 IU FSH starting on cycle day 2 and continued daily and adjusted according to the AFC and AMH.
干预措施: LH Suppression (Drug)
Dydrogesterone Suppression
Dydrogesterone 30 mg on stimulation day 5 till the trigger day to prevent luteinizing hormone (LH) surge. The stimulation is with 150-300 IU FSH/HMG starting on cycle day 2 and adjusted according to the AFC and AMH.
干预措施: LH Suppression (Drug)
Dydrogesterone Suppression with minimal stimulation
Dydrogesterone 30 mg on stimulation day 5 till the trigger day to prevent LH surge. The stimulation is with clomifene citrate 50 mg three times daily with150 IU FSH starting on cycle day 2 and continued every other day and adjusted according to the AFC and AMH.
干预措施: LH Suppression (Drug)
结局指标
主要结局
Live Birth after first Vitrified-warmed cycle
时间窗: 42 weeks of gestation
Delivery of one or more viable infants \> 20th weeks of gestation
次要结局
- Cumulative live birth(One year from randomization)
- Top-quality blastocyst on day 5(Within 6 days of culture)
- Term live-birth for vitrified-warmed transfer(Within 42 weeks of gestation)
- Clinical pregnancy(within 12 weeks of gestation)
- Ongoing pregnancy(within 24 weeks of pregnancy)
- Miscarriage(Within 20 weeks of pregnancy)
- Congenital malformation(Within one month of delivery)
- Fertilization(Within 6 days of culture)
- Embryo cleavage(Within 6 days of culture)
- Utilized embryos(Within 6 days of culture)
- Top-quality embryo on day 3(Within 6 days of culture)
- Blastocyst formation on day 5 or 6(Within 6 days of culture)
- Biochemical pregnancy(14 days after egg retrieval)
- Preterm Birth(Within 42 weeks of gestation)
- Very preterm birth(Within 42 weeks of gestation)
- Still birth(Within 42 weeks of gestation)
- Cryopreservation(Within 6 days of culture)
- Low birth weight babies(Within 24 hours of delivery)
- Live-birth-implantation rate(Within 42 weeks of gestation)
- Top-quality utilized embryos(Within 6 days of culture)
- Metaphase II oocyte(Within 24 hours of oocyte retrieval)
研究者
Muhammad Fawzy
IVF Lab Director
Ibn Sina Hospital