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临床试验/NCT02739516
NCT02739516已完成3 期

Concomitant Administration of Follicle-stimulating Hormone at the Time of Human Chorionic Gonadotropin Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility

Benha University0 个研究点目标入组 108 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
108
主要终点
Clinical pregnancy rate per cycle (PR/C) and per woman (PP/W)

研究概览

简要总结

The objective of this study was to evaluate the outcome of follicle stimulating hormone (FSH) co-administration with human chorionic gonadotrophins trigger for women with unexplained infertility (UEI) and assigned for letrozole (LTZ) stimulated intrauterine insemination (IUI) cycles .

详细描述

This prospective randomized controlled study included 108 women with unexplained infertility recruited among those attending the Gynecology Outpatient Clinics of, Benha University Hospital, and private settings, Alkalubia, Egypt from Jun 2013 to Aug 2015. The study protocol was approved by the Local Ethics Committee and written informed consents were taken from both partners before starting of the study.

All women received the same regimen of ovarian stimulation using Letrozole (Femara; Novartis pharma AG, Basle, Switzerland) 2.5 mg tab twice daily for 5 days starting from cycle day 3. Transvaginal ultrasound scan (TVS) was performed daily from cycle day 9 and a total of 10,000 IU of hCG (Epifasi, EPICO) was administered to those in whom at least one ovarian follicle was ≥18 mm in size. On the day of hCG administration women were randomly categorized into two groups according to a computer generated random numerical table. Envelopes containing the allocation information were chosen sequentially by patient herself in presence of her husband. Group A received FSH (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once on day of hCG injection and group B received no FSH on day of hCG injection. Intrauterine insemination was performed 36 hours after HCG injection. Women in both groups received luteal phase support in the form of vaginal progesterone, (Prontogest 400 mg Vaginal Pessaries, IBSA) twice a day, starting from the day after IUI and continued till the eighth week, if the pregnancy test was positive.Two weeks later, quantitative ßhCG was estimated to diagnose chemical pregnancy. However, TVS was performed 4 weeks after positive pregnancy test to confirm clinical pregnancy by the presence of gestational sac with fetal echoes and pulsation and to exclude ectopic pregnancy. All women enrolled in the study underwent the study protocol for three consecutive cycles unless got pregnant.

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 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Unexplained infertility for more than 2 years
  • Normal ovulation proved by midluteal serum progesterone level >5 ng/ml,
  • Patent fallopian tubes confirmed by hysterosalpingography or laparoscopy
  • Normal semen analysis according to the modified World Health Organization (WHO) criteria
  • Normal hormonal profile (FSH, LH, prolactin and TSH) in the early follicular phase.

排除标准

  • Other causes of infertility ( tubal factors, polycystic ovary syndrome (PCOS), endometriosis)
  • Ovarian cysts,
  • FSH >10 mIU/ml.
  • Previous intrauterine insemination (IUI )cycles,
  • Liver or kidney diseases,
  • Hypersensitivity to the used medications.

研究组 & 干预措施

Control

Active Comparator

In letrozole stimulated cycle: On the day of ovulation trigger the patient received standard dose of Human chorionic gonadotropin (10,000 IU).

干预措施: Human chorionic gonadotropin (Drug)

Control

Active Comparator

In letrozole stimulated cycle: On the day of ovulation trigger the patient received standard dose of Human chorionic gonadotropin (10,000 IU).

干预措施: Letrozole (Drug)

Study

Experimental

In letrozole stimulated cycle: On the day of ovulation trigger the patient received hCG 10000 IU plus FSH co-trigger (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once .

干预措施: Human chorionic gonadotropin (Drug)

Study

Experimental

In letrozole stimulated cycle: On the day of ovulation trigger the patient received hCG 10000 IU plus FSH co-trigger (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once .

干预措施: FSH co-trigger (Drug)

Study

Experimental

In letrozole stimulated cycle: On the day of ovulation trigger the patient received hCG 10000 IU plus FSH co-trigger (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once .

干预措施: Letrozole (Drug)

结局指标

主要结局

Clinical pregnancy rate per cycle (PR/C) and per woman (PP/W)

时间窗: Throughout the study completion; up to 3 months

Achievement of clinical pregnancy defined as the presence of an intrauterine gestational sac with a pulsating fetal heart beat on ultrasound

次要结局

  • Frequency of ovarian hyperstimulation syndrome (OHSS)(Throughout the study completion; up to 3 months)
  • Multiple pregnancies(Throughout the study completion; up to 3 months)
  • The live birth rate per woman (LB/W).(Throughout the study completion; up to 2 year)

研究者

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

Ahmed Walid Anwar Murad

Assistant Professor, Department of Obstetrics and Gynecology, Faculty of Medicine, Benha University

Benha University

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