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临床试验/NCT04855383
NCT04855383已完成不适用

The Effect of Intramuscular Injection of Triple Doses of Human Chorionic Gonadotropin in Frozen Embryo Transfer Cycles

Royan Institute1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Rate of Implantation

研究概览

简要总结

This study is a randomized controlled clinical trial to compare the pregnancy outcomes of infertile women with frozen embryo transfer. The study population in frozen embryo transfer cycles receive three doses of human chorionic gonadotropin (HCG) to recognize the effectiveness of HCG on pregnancy outcomes in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran.

详细描述

During implantation, the biochemical crosstalk between the endometrium and embryo has a very important role. The endometrium secrets cytokines and growth factors that modulate embryonic differentiation and early development. One of the important molecular messages between the embryo and endometrium is human chorionic gonadotropin (HCG). HCG is expressed by the blastocyst before the implantation, while increasingly produced after implantation by the syncytiotrophoblast. In order to study the direct effect of HCG on the endometrium at implantation, this randomized, controlled clinical trial evaluated whether HCG supplementation would be beneficial for pregnancy outcomes of cryopreserved-thawed embryo transfer with estrogen/ progesterone replacement cycles at Royan Institute.

Block randomization method is designed by epidemiologist using STATA software version 13 and the number of blocks considered is 6. The random allocation list for patients is solely available to the epidemiologist. In order to hide the random allocation process, a total of 200 envelopes are prepared, and only the methodologist has been aware of table of random numbers. When the doctor declared the patient's eligibility, the methodologist provided the doctor with the envelope. The group will be selected and based on the type of group mentioned in the envelope.

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

  • Infertile women candidates for frozen embryo transfer
  • Age 20-40 years
  • Body Mass Index under than 30 Kg/m2
  • Having at least three good quality embryos

排除标准

  • Women with hematologic and autoimmune disorders
  • Couples with chromosomal and genetic abnormalities
  • Women with uterine anomalies
  • Women with uterine and ovaries surgical history
  • Women with endometriosis and adenomyosis
  • Women with hydrosalpinx
  • Women with uterine fibroids
  • Women with history of recurrent abortion or recurrent implantation failure
  • Severe male factor infertility (azoospermia)
  • Embryo donation cycle
  • Endometrial thickness less than 8 millimeter on the day of embryo transfer

研究组 & 干预措施

The group of frozen embryo transfer with intramuscular injection of human chorionic gonadotropin.

Experimental

In this group, endometrial preparation for embryo transfer will be through the standard protocol using a gonadotropin-releasing hormone agonist. Patients receive 5,000 IU of human chorionic gonadotropin by intramuscular injection, 72 hours before embryo transfer, on the day of embryo transfer, and 72 hours after embryo transfer.

干预措施: The effect of intramuscular injection of triple doses of human chorionic gonadotropin in frozen embryo transfer cycles (Drug)

结局指标

主要结局

Rate of Implantation

时间窗: 6 weeks after embryo transfer

Implantation rate is the percentage of embryos which successfully undergo implantation compared to the number of embryos transferred in a given period.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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