Pilot Study: Optimal Trigger Time in Advanced Maternal Age Patients With Low AMH
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- the number of mature oocytes
研究概览
简要总结
The investigators want to verify if advanced maternal age patients with a low Anti-Müllerian hormone (AMH) level may benefit from an early trigger time (compared to a late trigger).
详细描述
During assisted reproduction, patients are stimulated in order to achieve a multifollicular development. The final step in this stimulation process is "the trigger" that will induce the final maturation of the oocytes. This timing is historically put once at least one follicle of 16-17 mm is obtained.
When looking at poor ovarian responder (POR) patients (characterized by a low AMH), the investigators observe shorter menstrual cycles and thus it is thought that the oocyte selected for ovulation, will also mature faster. This observation may indicate that POR patients potentially do not benefit from a trigger performed once a leading follicle of 17 mm is present, but rather from an earlier trigger.
The main objective is to analyse if an early trigger (leading follicle of 14 mm) results in the same maturation rate in POR patient as compared to a late trigger (17 mm). As the embryos will be cultured in a time lapse imaging system, annotations on the developmental kinetics can be made and the differences in fertilization rate and embryo development can be analysed as secondary outcome parameter. On top of this, patients will undergo a genetic testing of their embryos and this genetic analysis , together with the mtDNA copy number will also be compared between patients with early or late trigger. Euploid blastocysts will be transferred in subsequent frozen embryo transfer (FET) cycles and give an indication on the clinical outcome between IVF and ICSI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •• POR defined according to the Bologna criteria:
- •AMA: ≥40 years and AMH <1.1 ng/ml
- •Previous poor ovarian response with maximum 3 cumulus oocyte complexes retrieved after conventional stimulation
- •Antral follicle count < 5-7
- •Cycling patients
- •Fresh ejaculates
- •BMI 19-32 kg/m2
- •Ovarian stimulation protocol: Antagonist HMG 450 IU to ensure all receptors are covered and to ensure maximum recruitment. Dose adjustments can be made after 5 days of stimulation
- •Type of trigger for final oocyte maturation: dual trigger: 10.000 IU hCG i.m. and 0.3 mg Deca
- •Couples requesting preimplantation genetic testing (for aneuploidies) of their embryos
- •Follicular measurements should be performed at IVI RMA Fertility, Abu Dhabi, UAE: a single operator will perform the ultrasound for the final measurement before trigger. Recruitment can be done by all physicians
- •Only patients with an oral contraceptive pill (OCP) pretreatment to synchronize follicular development:
- •2 weeks OCP followed by
- •a wash out of 5 days (without OCP) followed by
- •o start stimulation
- •Basal hormone profile (FSH, LH, E2, P4) measured between day 1-3 at IVIRMA Fertility, Abu Dhabi, UAE
- •FSH <15 IU
- •E2 <50 pg/ml
- •P <1ng/ml
- •Only the Arab population
- •Oocyte retrieval: 36 hours after trigger
排除标准
- •If follicular measurement before randomization shows a leading follicle ≥ 13mm
- •History of:
- •Endometriosis AFS>2
- •Chemotherapy/radiotherapy
- •Ovarian surgery (iatrogenic)
- •Cyst puncture in the last three months
- •Sonographic finding of:
- •Hydrosalpinx
- •Ovarian cyst
- •Testicular samples and frozen ejaculates
- •If patients are pre-screened at the start of stimulation but no follicular development is observed, patients will not be randomized
- •Asynchronized follicular development at the moment of randomization: if the leading follicle is >3 mm lager than the smaller follicles.
- •All other hormonal pretreatments (except OCP) and all patients without hormonal pretreatment
研究组 & 干预措施
Late trigger
dual trigger (10.000 IU hCG i.m. and 0.3 mg Deca) once the leading follicle is 17 mm
干预措施: Dual trigger (Other)
Early trigger
dual trigger (10.000 IU hCG i.m. and 0.3 mg Deca) once the leading follicle is 14 mm
干预措施: Dual trigger (Other)
结局指标
主要结局
the number of mature oocytes
时间窗: 1 day
A mature oocyte is defined as an oocyte that has extruded his first polar body and this mature oocyte is ready to be fertilized by the participants sperm.
次要结局
- Maturation rate(1 day)
- Fertilization rate(1 day)
- Blastulation rate(7 days)
- Embryo development up to day 5(7 days)
- Mitoscore value: ranges from 10-1500(7 days)
- Pregnancy outcome(3 months)
- Embryo development up to day 3(3 days)
- Morphokinetic development(7 days)
- Ploidy state: euploid or aneuploid(7 days)