跳至主要内容
临床试验/NCT04528849
NCT04528849Unknown不适用

Comparison of Ovulation Induction Cycle Outcomes Between Early and Late Dose Increments for Low Dose Gonadotropin Step-up Protocol Among Infertile Women Diagnosed With Polycystic Ovary Syndrome: Prospective Randomised Trial

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年8月20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
入组人数
160
试验地点
1
主要终点
Number of preovulatory follicles

研究概览

简要总结

Low dose gonadotropin step-up ovulation induction treatment is the universally accepted and utilized teratment protocol for infertile women diagnosed with polycystic ovary syndrome (PCOS). First dose increment is advised on 14th day of ovarian stimulation with gonadotropins to decrease multiple follicle generation and cycle cancellation rates. However, clinicians impatiently increase gonadotropin dose on 7th day of stimulation without strong scientific evidence. This randomised controlled study will be the first study which will compare safety and ovulation induction cyle outcomes of early and late dose increments among infertile women diagnosed with PCOS.

详细描述

Low dose gonadotropin step-up ovulation induction treatment is the universally accepted and utilized teratment protocol for infertile women diagnosed with polycystic ovary syndrome. First dose increment is advised on 14th day of ovarian stimulation with gonadotropins to decrease multiple follicle generation and cycle cancellation rates. However, clinicians impatiently increase gonadotropin dose on 7th day of stimulation without strong scientific evidence. This randomised controlled study will be the first study which will compare safety and ovulation induction cyle outcomes of early and late dose increments among infertile women diagnosed with polycystic ovary syndrome.

We will start low dose step-up ovulation induction treatment by using 50 IU recombinant FSH for 21-39 years old non- obese patients (BMI <30 kg/m2) diagnosed with PCOS and . We will perform folliculometry on 7th day of ovulation induction. In case of absence for at least one >10 mm dominant follicle, we will randomise these women by using blind envelope selection method for assignment of early or late dose incerement groups. Half of the patients will receive 25 IU dose increment on 7th day of ovulation induction, remaining half will receive dose increment on 14th day of ovulation induction. We will continue ovarian stimulation without any other dose increment until 35th day of stimulation as deadline time restriction. We will perform folliculometry and serum estradiol measurement intermittently during ovulation induction. We will record ovulation induction cycle outcomes and clinical pregnancy results of the study group following finalization for treatment cyle of each patient. We will compare ovulation induction cycle outcomes of these two dose increment groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Infertile women who have been diagnosed with PCOS based on Rotterdam criteriae and who have not succeeded to get pregnant by using oral ovulation induction agents and whose BMI levels are <30 kg/m2 will be included to the study.

排除标准

  • Infertile women with tubal diseases, male factor infertility, endometriosis, previous pelvic surgery history, chronic systemic disease, BMI levels>30 kg/m2 and who are not voluntary to attend to the study will be excluded from the study.

研究组 & 干预措施

Early dose increment

Active Comparator

Patients who have received 25 IU gonadotropin dose increment on 7th day of ovulation induction

干预措施: Gonadotropin dose increment timing (Drug)

Late dose increment

Active Comparator

Patients who have received 25 IU gonadotropin dose increment on 14th day of ovulation induction

干预措施: Gonadotropin dose increment timing (Drug)

结局指标

主要结局

Number of preovulatory follicles

时间窗: 35 days

Number of \>14 mm sized follicles at the end of the ovulation induction treatment

次要结局

  • Biochemical pregnancy rate(2 weeks after ovulation triggering)
  • Multiple pregnancy rate(3 weeks after ovulation triggering)
  • Cycle cancellation(35 days)
  • Clinical pregnancy rate(3 weeks after ovulation triggering)
  • Cycle length in days(7-35 days)

研究者

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

Serkan Kahyaoglu

Associate Professor, M.D

Saglik Bilimleri Universitesi

研究点 (1)

Loading locations...

相似试验