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临床试验/NCT06304220
NCT06304220尚未招募不适用

Comparación de Dos Modelos de PPOS Para supresión Hipofisaria en Ciclos de estimulación ovárica, Desogestrel vs Medroxiprogesterona

NextFertility1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2024年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
210
试验地点
1
主要终点
Total number of oocytes retrieved from follicular puncture

研究概览

简要总结

The scarcity of evidence regarding the interchangeable use of different progestogens poses challenges, particularly in international egg donation and fertility preservation programs where standardizing protocols is crucial for achieving consistent efficacy, efficiency, and safety outcomes. Consequently, there's a pressing need for clinical studies to assess the effects of various progestogens on clinical outcomes in controlled ovarian hyperstimulation cycles. This study, a pioneering effort, aims to compare the effects of two progestogens on oocyte performance, safety, and efficiency in an egg donation program involving young, healthy, normo-responding patients.

详细描述

This is a multicenter, randomized, controlled clinical study comparing two different progestogens for pituitary suppression in normo-responding patients undergoing controlled ovarian hyperstimulation (COH) for egg donation. Patients will be recruited on the day they begin the egg donation program. Before inclusion, patients must meet all inclusion and exclusion criteria and provide written informed consent. Each patient will be assigned a patient code based on the treatment group they are included in. Treatment with the assigned progestogens will start on the first day of COH. The standard protocol for egg donation will be followed, including stimulation with FSHr (Puregon®), pituitary suppression with either Medroxyprogesterone acetate (Progevera®) or Desogestrel (Cerazet®), and trigger with GnRH agonist (Triptorelin acetate, Decapeptyl®) 36 hours before oocyte retrieval. Patients will continue taking the assigned progestogen throughout the COH period. Oocyte quality will be assessed based on maturity and morphology, with mature oocytes classified as normal or good quality and abnormal oocytes categorized into intracytoplasmic and extracytoplasmic abnormalities. Quality assessment will be performed by two blinded embryologists.

研究设计

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

入排标准

年龄范围
18 Years 至 34 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • BMI of 18-29,9 kg/m2
  • Ultrasound count of antral follicles prior to COH ≥ 12 follicles
  • Meeting the criteria for inclusion in the egg donation program
  • Normal karyotype and no active sexually transmitted diseases
  • No use of combined hormonal contraceptives one month before COH

排除标准

  • Patients excluded from the egg donation program
  • Untreated sexually transmitted diseases, positive serology for HBV, HIV, HCV
  • Blood disorders, neurodegenerative/psychiatric diseases, carriers of X-linked genetic diseases, oncological diseases, endometriosis.
  • Oligomenorrhea (<1 menstrual cycle in 3 months)
  • Use of combined hormonal contraceptives before COH

研究组 & 干预措施

Group DSG: Desogestrel

Active Comparator

Desogestrel Cerazet® 75 mg/day orally from the first day of controlled ovarian hyperstimulation (COH) until the day of trigger with agonist (GnRH-a).

干预措施: Cerazet (Drug)

Group MPA: Medroxyprogesterone

Active Comparator

Medroxyprogesterone acetate Progevera® 10 mg/day orally from the first day of controlled ovarian hyperstimulation (COH) until the day of trigger with agonist (GnRH-a).

干预措施: Cerazet (Drug)

结局指标

主要结局

Total number of oocytes retrieved from follicular puncture

时间窗: 5 months

The total number of oocytes retrieved from the follicular puncture shall be counted.

Number of mature oocytes (MII) retrieved from follicular puncture

时间窗: 5 months

The number of mature oocytes (MII) recovered from the follicular puncture shall be counted.

次要结局

  • Oocyte quality variables(5 months)
  • Ovarian sensitivity index (OSI(5 months)
  • Follicles(5 months)

研究者

发起方
NextFertility
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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