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临床试验/NCT04695483
NCT04695483已完成4 期

Reduction of Progesterone Elevation at Trigger in Poor Responder Bologna' Criteria Patients After Controlled Ovarian Stimulation With Long Acting Standard Stimulation Protocol Compared With Conventional Daily Protocol: a Single Center Prospective Randomized Fase IV Trial

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2022年2月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
110
试验地点
1
主要终点
Premature progesterone elevation

研究概览

简要总结

The overarching objective of this research is to generate clinical evidence to argue the benefits of long acting stimulation protocol compared to the daily stimulation protocol in poor ovarian responder bologna' criteria patients after controlled ovarian stimulation. Reduction in the proportion of subjects with progesterone > 1.1 ng/ml on the day of triggering (day + 13) in the experimental group compared to the control group is expected.

详细描述

Each patient will receive a first visit for infertility where will be collected subject history and baseline information, and meet all the inclusion / exclusion criteria. Eligible patients who agreed to participate will be randomized to either long acting standard COS with corifollitropin alpha or standard COS with daily FSH in a fixed GnRH antagonist protocol. All patients will be allowed to participate in the study only once and a written informed consent will be obtained from all, following consultation and before the initiation of the treatment.

The endocrine profile of all the patients will be evaluated by analysis of serum progesterone, 17b-estradiol (E2), FSH and LH at different time points: basal condition, during stimulation, at the hCG day and at pick-up.

Transvaginal follicular aspiration will be performed by ultrasound guidance 36 hours after hCG administration. The day of pick up oocytes will be fertilized with partner's semen; after 3-5 days, on the base of its evolution, embryo will be transferred. 14 days after embryo-transfer a preg-nancy test will be performed. Follow up in case of obtained pregnancy will be done until 20 weeks of gestation and considered as ongoing pregnancy.

The entire duration of the study is 24 months, the follow up of the last patients enrolled will be 6 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
25 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Indication to IVF treatment
  • Normal BMI (18.5-24.9 kg/m2)
  • AMH level < 1.1 ng/ml and/or AFC < 5 follicles and/or < 3 oo-cytes retrieved in previous cycle
  • Regular menstrual cycles
  • Signed informed consent

排除标准

  • Freeze all cycles for abnormal bleeding
  • History of untreated autoimmune
  • Endocrine or metabolic disorders
  • Ovarian cystectomy or oophorectomy
  • FSH ≥ 20 lU/L

研究组 & 干预措施

Corifollitropin alpha group

Experimental

Patients treated with Corifollitropin-alpha in a long-acting controlled ovarian stimulation

干预措施: Corifollitropin alfa (Drug)

Corifollitropin alpha group

Experimental

Patients treated with Corifollitropin-alpha in a long-acting controlled ovarian stimulation

干预措施: Follitropin Beta (Drug)

FSH group

Active Comparator

Patients treated with Follitropin beta in a daily controlled ovarian stimulation protocol

干预措施: Follitropin Beta (Drug)

结局指标

主要结局

Premature progesterone elevation

时间窗: day 12

Progesterone \> or equal to 1.1 ng/mL at day of trigger

次要结局

  • Number of oocytes collected at ovum retrieval(day 14)
  • Fertilization rate(day 15)
  • Percentage of freeze-all cycles due to premature progesterone elevation(day 12)
  • Pregnancy rate(day 30)
  • Number of embryos available(Day 17)
  • Ongoing pregnancy(Up to 20 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Enrico Papaleo

MD

IRCCS San Raffaele

研究点 (1)

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