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临床试验/NCT05767086
NCT05767086已完成不适用

Comparison of Cetrorelix, Medroxyprogesterone Acetate and Dydrogesterone for Preventing Premature Ovulation in Ovarian Stimulation Cycles

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 297 人开始时间: 2023年3月15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
297
试验地点
1
主要终点
Rate of clinical pregnancy

研究概览

简要总结

The aim of study is to evaluate the results of three different protocols for prevention of premature ovulation in ovarian stimulation cycles. All patients that undergo IVF cycles are randomly divided into three groups. The first group is cetrorelix, the second group is medroxyprogesterone acetate and the third group is dydrogesterone.

详细描述

Approximately %10-15 of couples of reproductive age have infertility issues. Ovulation induction and in vitro fertilization (IVF) are the main treatments for infertility. With ovarian stimulation (OS), the efficiency of IVF has been increased by collecting more than one oocytes and thus providing more embryos. Multifollicular growth in OS may cause an increase in sex steroids and an early LH peak, thus premature ovulation. Pituitary suppression with certain drugs has been used to prevent premature ovulation.. Among these drugs, it has been observed that GnRH agonists can cause down-regulation, hypo-estrogenic symptoms, ovarian cyst formation and Ovarian Hyperstimulation Syndrome (OHSS), while antagonists may have side effects such as low oocyte count and high cycle cancellation. The use of progesterone preparations as an alternative to these drugs recently gained ground.

Data including age, BMI, the duration of infertility, the type of infertility, antral follicle count, serum day 3 FSH level, Serum anti-Müllerian hormone level, total gonadotropin dose, stimulation time, pituitary suppression starting day, duration of pituitary suppression, premature ovulation, number of total oocyte count, the number of total M2, the number of PN , the number of Day 5 blast, number of transferred embryos, endometrial thickness on the day of transfer will be recorded. When the follicle size reaches 13-14 mm, patients will be randomized into 3 groups. Group 1 (Cetrorelix: n=99, 0.25 mg/day subcutaneously), Group 2 (Medroxyprogesterone Acetate: n=99, 2x5mg/day orally) and Group 3 (Dydrogesterone: n=99, 3x10 mg/day orally). Human chorionic gonadotropin (hCG) will be used for trigger when at least 2 follicles' diameter reaches 17-18mm for ovulation. Thirty-six hours after the hCG injection, the patient's oocytes will be collected. During 2-5 days of embryo culture, embryo quality will be determined according to D.Gardner criteria (1999). Embryos will be frozen as blast on the 5th day and transferred to the frozen cycle to be planned within the next month. Clinical pregnancy rates will be recorded by performing a blood test for on the 12th day after the procedure.

The aim of this study is to evaluate the results of three different protocols for prevention of premature ovulation in ovarian stimulation cycles. All patients undergo IVF cycles are randomly divided in to three groups. The first group is cetrorelix, the second group is medroxyprogesterone acetate and the third group is dydrogesterone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 20-38 years who applied to the infertility clinic
  • BMI<25 kg/m2
  • AMH>1 ng/mL

排除标准

  • Adenomyosis
  • Endometriosis
  • Untreated uterine pathology
  • Hormonal therapy in the last 3 months
  • Contraindication for ovulation stimulation
  • BMI>25 kg/m2
  • AMH<1 ng/mL

研究组 & 干预措施

Gonadotropin-releasing hormone (GnRH) antagonist

Experimental

Cetrotide® (0.25 mg, MerckSerono Pharmaceuticals, Darmstadt, Germany)

干预措施: Gonadotropin releasing hormone antagonist (Cetrotide) (Drug)

Medroxyprogesterone acetate

Experimental

Tarlusal® (5 mg, Deva Pharma, Istanbul, Turkey)

干预措施: Medroxyprogesterone Acetate (Tarlusal) (Drug)

Dydrogesterone

Experimental

Duphaston® (10mg, Abbott Laboratories, Chicago, Illinois, ABD)

干预措施: Dydrogesterone (Drug)

结局指标

主要结局

Rate of clinical pregnancy

时间窗: 4-5 weeks after IVF

fetal heartbeat by transvaginal ultrasound

次要结局

  • Rate of ongoing pregnancy(Months 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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