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临床试验/NCT05300841
NCT05300841Unknown早期 1 期

The Effect of Pretreatment With Dydrogesterone Vs Combined Estradiol Valerate and Dydrogestrone on Clinical Pregnancy Outcome of ICSI in PCOS Patients"

Sohag University0 个研究点目标入组 500 人开始时间: 2022年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
500
主要终点
Clinical pregnancy rate

研究概览

简要总结

To analyze the effect of pretreatment with dydrogesterone vs combined estradiol valerate and dydrogesterone on embryologic parameters, chemical and clinical pregnancy rates of ICSI in women with PCOS.

详细描述

Polycystic ovary syndrome (PCOS) is a very common endocrine disorder affecting 5-7% of women in reproductive age. It is the leading cause of anovulatory infertility in this age group. It is characterized by ovulatory dysfunction, hyperandrogenism and polycystic ovary morphology on ultrasonography.

Assisted reproductive techniques (ART) are indicated when infertile women with PCOS are unable to become pregnant through standard ovulation induction methods. Many protocols have been used for ovulation induction in ICSI , GNRH agonist and GNRH antagonist protocols are the most commonly used nowadays. GNRH antagonist protocol use has been increased due to its high safety profile and progressive physician experience in controlled ovarian stimulation .

Steroid pretreatment is steroid administration in the cycle preceding the ICSI cycle. Due to oligo-menorrhea & unpredictability of menstruation in PCOS, steroid pretreatment is used to schedule the start of an ICSI cycle in women with PCOS. Also, it is expected to synchronize (homogenize) the follicular cohort, and thus increase both oocyte yield and gamete quality. Moreover, steroid pretreatment may have an impact on cycle outcome.

For these reasons, more attention has been paid to the potential interest of steroid pretreatments for scheduling GnRH antagonist cycles. Three main options have been used to achieve cycle programming. First the combined oral contraceptive pill (COCS)seems to be effective for scheduling menstruation but is not associated with increased oocyte yield . Furthermore, a meta-analysis pointed out that COCS pretreatment may be associated with fewer clinical pregnancies.Second, synthetic progestogens are good candidates because of their potent suppressive effect on pituitary gonadotrophin secretion and was associated with higher clinical pregnancy rate than COCS, placebo or no treatment. Finally, luteal administration of natural estrogens was proved to improve the synchronization of early antral follicle growth and to allow retrieval of two additional oocytes.

Either waiting for a spontaneous menses or using progestin is a better option than using COCs to induce menses in women with PCOS prior to ovarian stimulation using GnRH antagonist protocol for IVF. PCOS women using COCs had a lower live birth rate after fresh embryo transfer when compared with women using progestin for inducing menses or those with spontaneous menses. This difference, however, was not observed in the group who received an FET.

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

  • -Women with PCOS undergoing their first cycle of ICSI. PCOS diagnosis will be performed based on Rotterdam criteria (2003) based the presence of oligomenorrhea, polycystic ovaries on ultrasonography (defined as either an ovary that contains ≥ 12 antral follicles or ovarian volume>10cm3) as well as biochemical or clinical signs of hyperandrogenism, and after exclusion of other causes of hyperandrogenism as Cushing syndrome and CAH and hypothyroidism.
  • age 18 to 35 years.
  • BMI between 19 and 25 kg/square meter.
  • AMH 3.5-6 ng/ml
  • fresh or frozen embryo transfer

排除标准

  • -FSH more than 12 IU /L
  • AFC- performed on day 3 of the cycle- less than 4
  • Existence of hydrosalpinx on ultrasonography
  • uterine disorders as that caused by uterine fibroids.
  • . All male partners should have normal semen parameters .
  • Women with more than 20 oocytes
  • Any sign of early onset OHSS

研究组 & 干预措施

Dydrogesterone group

Active Comparator

Pretreatment with dydrogestrone (Duphaston, Abott Healthcare, Egypt) will be administered during the cycle preceding the ICSI cycle in a daily dose of 20 mg/ day starting 10 days before the presumed onset of menses

干预措施: dydrogesterone 20 mg /d (Duphaston, Abott Healthcare , Egypt) (Drug)

Dydrogesterone plus estradiol valerate group

Active Comparator

will receive dydrogestrone 10mg /day plus estradiol valerate 2 mg /d (white tablets of cycloprognova, Bayer Schering, Germany) for 10 days.

干预措施: dydrogesterone 20 mg /d (Duphaston, Abott Healthcare , Egypt) (Drug)

Dydrogesterone plus estradiol valerate group

Active Comparator

will receive dydrogestrone 10mg /day plus estradiol valerate 2 mg /d (white tablets of cycloprognova, Bayer Schering, Germany) for 10 days.

干预措施: estradiol valerate 2 mg /d (white tablets of cycloprognova, Bayer Shering, Germany) (Drug)

结局指标

主要结局

Clinical pregnancy rate

时间窗: 6 gestational weeks

u/s visualization of a gestational sac and embryonic pole with heart beat expressed per per100 embryo transfer cycles.

chemical pregnancy rate

时间窗: 6 gestational weeks

positive pregnancy test in serum or urine without ultrasound evidence of a gestational sac; expressed per100 embryo transfer cycles.

次要结局

未报告次要终点

研究者

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

Ahmed Salah Ali

Principal Investigator

Sohag University

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