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临床试验/NCT03358732
NCT03358732已完成不适用

Effect of Intrauterine Navigation Using Intrauterine Insemination Catheter for Mock Embryo Transfer Prior to Day 3 Embryo Transfer on Pregnancy Rate: A Pilot Study

King Fahad Medical City1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2016年10月2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
45
试验地点
1
主要终点
Pregnancy rate

研究概览

简要总结

Objective: To evaluate the effect of intrauterine navigation using intrauterine insemination catheter (IUI) one day prior to day 3 embryo transfer (ET) on pregnancy rate.

Design: Pilot randomized controlled study. Setting: Tertiary referral center, King Fahad Medical City. Patients: Patients who underwent ET during the period of the study after two or less in-vitro fertilization failures and fulfilled the inclusion criteria.

Interventions: Mock ETs were performed on day 2 post oocytes retrieval using intrauterine insemination catheter, followed by day 3 ET.

Main Outcome Measure: Pregnancy rate.

Key Words: embryo transfer, mock embryo transfer, endometrial receptivity, endometrial scratching, IVF.

详细描述

Materials and Methods Population Forty-five patients were selected for this prospective randomized control trial. It was conducted between October 2016 and October 2017 in the Reproductive Endocrinology and Infertility Medicine Department of King Fahad Medical City (KFMC).

We included nulliparous patients who were < 42 years of age with body mass index (BMI) < 30 kg/m2 and normal endometrial cavity, used fresh sperm or oocytes, had two or more embryos available for transfer on day 3 post ovum pick-up (OPU), and no more than 3 previous unsuccessful ART cycles. Patients with uterine fibroids, uterine anomalies, intra-uterine adhesions, and uterine polyps, patients with chronic diseases in the as uncontrolled diabetes or hypertension, or if the patient had difficult mock ET . patients with severe male factors for infertility requiring surgical retrieval of sperms were excluded from the study.

Ethical clearance of this study was obtained from the ethical committee of KFMC (IRB 00008644). Written informed consent was obtained from all the participants.

Stimulation Protocols Participants were assigned either to the antagonist or agonist protocol. In the agonist stimulation protocol, pituitary desensitization was achieved by using 3.75 mg leuprolide acetate (Lupron Depot, Abbott Laboratories, Chicago, USA) intramuscularly in the luteal phase of the previous cycle. The participants received 75-450 IU/d of either recombinant follicle-stimulating hormone (FSH) (Gonal-F; Serono, Munich, Germany) or highly purified human menopausal gonadotrophin (hMG) (Merional; IBSA, Lugno, Switzerland). The dosage was adjusted according to the serum E2 levels and vaginal ultrasound folliculometry. In the antagonist protocol group, 0.25 mg/d cetrorelix acetate (Cetrotide; Serono, Munich, Germany) was added on the day 5 of stimulation. When the sizes of three or more follicles became ≥16 mm, the patient was given 10,000 IU of chorionic gonadotrophin (Pregnyl; MERK, Hally, Germany) intramuscularly.

Oocyte Retrieval and Fertilization Transvaginal oocyte retrieval was scheduled 36 h after the administration of hCG and was performed under local anesthesia. Fertilization was achieved by intracytoplasmic sperm injection (ICSI). Pronuclear observation to determine fertilization was performed 16-18 h after insemination. A commercial sequential IVF medium (Cook, Eight Miles Plains, Queensland, Australia) was used for procedures involving the handling of gametes and embryos. All embryos were transferred on their respective day 3 post OPU.

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
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •We included nulliparous patients who were < 42 years of age with body mass index (BMI) < 30 kg/m2 and normal endometrial cavity, used fresh sperm or oocytes, had two or more embryos available for transfer on day 3 post ovum pick-up (OPU), and no more than 3 previous unsuccessful ART cycles

排除标准

  • •Patients with uterine fibroids, uterine anomalies, intra-uterine adhesions, and uterine polyps, patients with chronic diseases in the as uncontrolled diabetes or hypertension, or if the patient had difficult mock ET . patients with severe male factors for infertility requiring surgical retrieval of sperms were excluded from the study.

研究组 & 干预措施

Mock embryo transfer

Experimental

The patients underwent a mock embryo transfer one day before the scheduled actual transfer

干预措施: endometrial navigation one day before the embyo transfer using IUI catheter , (Device)

No mock embryo transfer

No Intervention

The patients did not undergo mock embryo transfer one day before the scheduled actual transfer

结局指标

主要结局

Pregnancy rate

时间窗: 1 month

Proportion of women with visualization of intrauterine gestation sac with positive fetal heart

次要结局

未报告次要终点

研究者

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

Sahar Abbas Lary

Consultant

King Fahad Medical City

研究点 (1)

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