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临床试验/NCT06577974
NCT06577974招募中不适用

Does the Medical Tretament Prior to Stimulation Affect the Fertility Outcome in Cases of Endometriosis Associated Infertiltiy

Cairo University2 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2024年7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
招募中
入组人数
129
试验地点
2
主要终点
Fertilisation rate

研究概览

简要总结

The aim of this study to assess the effect of medical treatment prior to stimulation on fertility (ICSI) outcome in cases with endometriosis associated infertility.

详细描述

Patients complaining of infertility due to endometriosis diagnosed by ultrasound or laparoscopic surgery will be randomly allocated to three groups :

Group A: will receive COCPs for 3-6 months prior to starting IVF / ICSI cycle. Group B: will receive Dienogest for 3-6 months prior to starting IVF / ICSI cycle.

Group C: will be subjected to direct ICSI /IVF cycle. Then all patients will be subjected to ovarian stimulation regimen using GnRH Agonist Down-Regulation Gonadotropin Stimulation-The "Long" Protocol.

During the ovarian stimulation, the woman's response is monitored with serum estradiol levels and vaginal ultrasound examinations. The estradiol level is used to determine the dose of gonadotropins and whether under- or overstimulation occurs. The goal of the ovarian hyperstimulation is to develop at least three mature follicles that are 17 mm in diameter or larger. Once this is achieved, FSH and other medications are discontinued, and a single injection of hcg is given to mature the eggs to allow fertilization.

The hcg administration will also cause ovulation, but this does not occur until 40 hours or later after the injection. Therefore, it is standard that the hcg injection is administered 36 hours before the scheduled egg retrieval such that this will allow adequate maturation of the eggs and yet there would be little risk of ovulation.

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
Double (Participant, Investigator)

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

  • Presence of Endometrioma on ultrasound.
  • History of ovarian cystectomy either open or via laparoscopic surgery.
  • Presence of endometriotic foci in the pelvis during laparoscopic surgery.
  • Patients coming for the first ICSI / IVF cycle.

排除标准

  • Age above 40 years
  • Cases with endometrioma on ultrasound more than 3 cm size.
  • Prior failed ICSI / IVF.
  • Known poor responders or poor ovarian reserve, defined as AFC<5 or AMH < 0.5 .
  • Patients with previous uterine surgery.
  • Patients diagnosed to have uterine abnormalities

研究组 & 干预措施

Those treated by COCPs before IVSI

Experimental

Those with endometrisosis who will undergo ICSI after pretreatment with COCPs

干预措施: Combined contraceptive pills (Yasmin) (Drug)

Those treated by Dionogest before ICSI

Experimental

Patients diagnosed with endometriosis who will undergo ICSI after oreteatment by dienogest

干预措施: Combined contraceptive pills (Yasmin) (Drug)

结局指标

主要结局

Fertilisation rate

时间窗: 2 weeks from starting induction

Number of embryos

次要结局

  • clinical pregnancy rate(2 weeks from embryo transfer)

研究者

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

Mariam Ahmed Mohamed Dawoud

Associate professor

Cairo University

研究点 (2)

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