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临床试验/NCT05951400
NCT05951400已完成2 期

Progesterone Primed Ovarian Stimulation Protocol (PPOS) VS GnRH Antagonist Protocol in Patients With Expected High Ovarian Response Undergoing ICSI Cycles: a Prospective Randomized Controlled Trial

Beni-Suef University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
200
试验地点
2
主要终点
oocytes retrieved

研究概览

简要总结

To compare the effectiveness and safety of Progesterone Primed Ovarian Stimulation protocol (PPOS) using Dydrogestrone vs GnRH Antagonist Protocol in patients with expected high ovarian response undergoing ICSI cycle

详细描述

Each patient will be subjected to:

Full history taking. Systematic clinical examination to assess the general condition, body mass index (BMI) and local pelvic physical findings and AFC by trans-vaginal ultrasound on D2 to 3 of menstruation.

Routine labs as CBC, liver & kidney functions to exclude general disease as a contraindication for induction or pregnancy.

Blood sample will be obtained for assessment of basal serum levels of FSH, LH, E2 on days 2- 3 of the cycle. PRL, AMH and TSH Ovarian Stimulation The patients will begin injections of recombinant FSH (rFSH, Gonal-F; Merck-Serono, Italy) from day 2-3 of menstruation, with daily dose of 150-300 IU adjusted according to individual conditions on the basis of the antral follicle count (AFC),hormonal profile, age, body mass index (BMI), and previous ovarian response, according to the standard operating procedures of the center. .

For pituitary suppression, the patients will receive either Dydrogestrone (Duphaston30mg/d; Abbott Healthcare, USA) orally starting at day 2-3 or GnRH antagonist Cetrorelix (CETROTIDE 0.25Mg/d, Merck Serono, Germany) 0.25 mg/day subcutaneously from day 6 of induction until trigger day.

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
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • undergoing trial of ICSI.

排除标准

  • Any known contraindications to the approved fertility drugs.
  • Severe endometriosis.
  • Uterine malformations or abnormal uterine cavity.
  • Uncontrolled endocrinopathies:DM,hyperthyroidism, hypothyroidism
  • Severe male factor
  • History of recurrent ICSI failure or recurrent miscarriage

研究组 & 干预措施

Dydrogestrone

Experimental

For pituitary suppression, the patients will receive either Dydrogestrone (Duphaston30 mg/d; Abbott Healthcare, USA) orally starting at day 2-3

干预措施: Dydrogesterone Tablets (Drug)

GnRH antagonist

Active Comparator

For pituitary suppression, the patients will receive GnRH antagonist Cetrorelix (CETROTIDE 0.25Mg/d, Merck Serono, Germany) 0.25 mg/day subcutaneously from day 6 of induction until trigger day.

干预措施: Cetrorelix (Drug)

结局指标

主要结局

oocytes retrieved

时间窗: 1 month of induction for ICSI trial

Number of oocytes retrieved classified

次要结局

  • Duration of stimulation days.(1 month)
  • chemical pregnancy rate(1 month)

研究者

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

Sara Abdallah Mohamed Salem

Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Beni-Suef University

研究点 (2)

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