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临床试验/NCT06297564
NCT06297564已完成不适用

Progesterone Primed Endometrial Protocol Versus Gonadotropin-releasing Hormone Antagonist Protocol in Women Undergoing Assisted Reproductive Treatments

New Valley University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
The number of retrieved oocytes

研究概览

简要总结

The aim of this study was to compare the clinical outcomes in progesterone primed endometrial protocol versus gonadotropin-releasing hormone antagonist protocol in women undergoing assisted reproductive treatments.

详细描述

Utilizing the assisted reproductive techniques (ART) has exhibited a substantial rise within the last years, emerging as a crucial modern medicine component with reliable results.

The utilized protocols for endometrial preparation in ART are aimed at maximizing the treatments' success. Typically, utilizing gonadotropin-stimulating hormone (GnRH) antagonists or agonists remains involved for preventing an early luteinizing hormone (LH) peak along ovulation prior to oocytes retrieval.

The GnRH-antagonist (GnRH-a) protocol is favored by many clinicians as well as patients due to its simplicity, convenience, flexibility, and absence of functional ovarian cysts or "menopausal" symptoms linked to the agonist protocol. Nevertheless, some RCTs' findings address that the antagonist protocol yields a reduced oocytes' number. Additionally, it exhibits lower pregnancy rates as opposed to the agonist extended therapy.

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
21 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 21 to 40 years.
  • A basal antral follicle count (AFC) <
  • All patients had to have a body mass index between 18.5 to 29.9 kg/m
  • Undergoing IVF/ICSI cycles.
  • With previous poor response to conventional prolonged therapy utilizing GnRH agonists (retrieving three oocytes).

排除标准

  • Cycles with fresh embryo transfer.
  • Transfers of cleavage embryos (d2/d3).
  • Embryos from cycles with preimplantation genetic screening.
  • Cryopreservation of oocytes.
  • Oocyte donation cycles.
  • Cycles that produced embryos but without et at the time of the analysis.

研究组 & 干预措施

Progesterone primed endometrial protocol

Active Comparator

The cases were received soft progesterone capsules (brand name: Utrogestan, 100 mg, Laboratories Besins International, France) 100 mg and 150 IU of human menopausal gonadotropin (hMG) concomitantly from the menstrual cycle (MC) day 3 until the trigger day

干预措施: Progesterone primed endometrial protocol (Other)

Gonadotropin-releasing hormone antagonist protocol

Experimental

The cases were received the gonadotropin-releasing hormone antagonist (GnRH-ant) protocol consisting of HMG 150 IU's daily injection from MC 3 until the trigger day. GnRH-ant (Cetrotide, 0.25 mg, MerckSerono) was started when at least one of the following criteria were met: LH >10 IU/L, the presence of at least one follicle with mean diameter >14 mm, or serum E2 level >600 pg/mL.

干预措施: Gonadotropin-releasing hormone antagonist protocol (Other)

结局指标

主要结局

The number of retrieved oocytes

时间窗: 34 to 36 hours post HCG administration

Retrieved oocytes will be collected after ovarian induction by gonadotropin injection

次要结局

  • Pregnancy rate(Fourteen days following the transfer)

研究者

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

Waleed Ahmad Ali

Lecturer of Obstetrics and Gynecology, Faculty of Medicine, New Valley University.

New Valley University

研究点 (2)

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