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临床试验/NCT05854810
NCT05854810已完成不适用

Single Versus Double Frozen Embryo Transfer in PCOS Patients

Zagazig University2 个研究点 分布在 1 个国家目标入组 271 人开始时间: 2019年6月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
271
试验地点
2
主要终点
the live birth rate (LBR) after SBT and DBT

研究概览

简要总结

Polycystic ovarian syndrome (PCOS) is condition characterized by being complex, familial and polygenetic metabolic condition with heterogeneous involvement of several genes in the hypothalamic-pituitary-gonadal axis. PCOS is the most incident endocrine-metabolic syndrome that is characterized by hyperandrogenemia, menstrual irregularities, and/or small cysts in one or both ovaries and could be considered as the main cause of female infertility.

Assisted reproductive technologies (ART) were defined by the American Center for Disease Control as any fertility-related treatments where eggs or embryos are manipulated. In vitro fertilization involves the transfer of fresh embryos, however, the freeze-all strategy that entails cryopreservation of all embryos to be transferred subsequently in un-stimulated cycle to guard against the negative effects of controlled ovarian stimulation on the endometrium and to minimize the risk of ovarian hyper-stimulation syndrome. Intracytroplasmatic sperm injection (ICSI) is a common procedure used to improve reproductive results, even among couples without male factor infertility.

However, there are several points of controversy in the fields of ART traditionally, multiple embryo transfer strategy was used to increase the chance for getting a baby, however, multiple pregnancy is a common complication for this strategy with subsequent adverse fetal, maternal and neonatal outcomes. Also, the developmental stage of embryos at time of transfer; cleavage versus blastocyst was a matter of debit, but giving the chance for in-vitro maturation to the stage of blastocyst increased the possibility of getting good quality embryo to be transferred. However, the exaggeration of prolongation of the in-vitro duration appeared as a trend, but recent studies found no advantages for transfer of D7 or D6 blastocyst over D5 blastocyst transfer (BT).

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
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Infertile women fulfilling at least two of the Rotterdam criteria for diagnosis of PCOS;
  • aged 20-35 years;
  • had body mass index (BMI) of less than 35 kg/m2;
  • mild hirsutism on Ferriman-Gallwey (FG) visual scoring system;
  • their hormonal profile of serum AMH >4.5, FSH <5.85 LH>5.39;
  • had no previous attempts of ICSI were included in the study.

排除标准

  • Patients who were out of the predetermined age range and BMI;
  • had uterine abnormalities;
  • hydrosaplnix;
  • recurrent miscarriage;
  • medical diseases interfering with or being complicated by occurrence of pregnancy;
  • cases requiring ICSI with TESE samples;
  • had obesity-inducing endocrinopathy
  • severe symptomatizing hypovitaminosis or maintained on hormonal contraception within the last 6 months before inclusion in the study, were excluded from the study.

结局指标

主要结局

the live birth rate (LBR) after SBT and DBT

时间窗: 9 months

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

Walid Mohamed Elnagar

Assistant professor of gynecology

Zagazig University

研究点 (2)

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