Effect of Endometrial Biopsy on in Vitro Fertilization Pregnancy Rates - a Randomized, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Clinical Pregnancy Rate
研究概览
简要总结
Animal and clinical studies have suggested that local tissue trauma can promote the process of an embryo implanting in the uterine cavity. The clinical studies have been performed in patients with a history of previously failed treatments using in vitro fertilization; a process of stimulating many eggs from a women and removing them from the body, to allow fertilisation with sperm to occur in a laboratory setting. The embryos are then replaced into the uterine cavity.
This study questions whether endometrial biopsy (placing a small straw like catheter through the cervix and into the uterine cavity to take a sample of tissue via suction into the bore of the catheter), within 5-10 days of starting a cycle of in vitro fertilization, will improve pregnancy outcome for patients in the first or second cycle of treatment. The hypothesis is that endometrial biopsy will improve pregnancy outcome.
The study is a randomized multicentre study involving 3 Canadian fertility centres.
详细描述
Although the data are preliminary, there are studies suggesting that mild endometrial trauma in the cycle preceding IVF increases pregnancy rates, at least in women with recurrent implantation failure. Whether endometrial biopsy could promote implantation and improve pregnancy rates in the larger population of women undergoing IVF has yet to be explored. The present study will address this question and examine the impact of endometrial biopsies on IVF outcomes in the context of a randomized controlled trial.
The optimal timing of the endometrial biopsy in the cycle preceding IVF has not been determined, but the majority of the studies have included a biopsy in the mid-luteal phase of the preceding cycle. In order to allow an adjuvant therapy to IVF that would be considered tolerable to a subject, and applicable to a large infertile women population, it was determined that a single endometrial biopsy, performed approximately 1 week prior to the start of controlled ovarian hyperstimulation (COH) in an IVF cycle, would be the simplest, most flexible, and generalizable intervention to study its effects on pregnancy rates. All other components of the IVF treatment will remain constant with approximately 8-12 days of ovarian stimulation, human chorionic gonadotrophin (HCG) trigger being administered in that time frame and oocyte retrieval occuring 36 hours later from trigger. The embryo transfer will take place either day 3 or day 5 after oocyte retrieval.
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 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing first or second IVF cycle, with or without ICSI
- •Age 18-39
- •BMI 18-35 kg/m2
- •Uterine cavity evaluation (hysterosalpingogram, sonohysterogram, hysteroscopy) in the preceding 24 months
- •Early follicular phase (Day 2 or Day 3) serum FSH, evaluated in the preceding 6 months
- •ONE of the following:
- •Non- oral contraceptive pill (non-OCP) subjects: Documented LH surge 9-11 days prior to enrollment
- •Current OCP subjects: OCP use for ≥ 10 days
- •Use of long GnRH agonist or GnRH antagonist protocol
- •Subject able to give informed consent
排除标准
- •Prior enrolment in this study
- •Any prior early follicular phase serum FSH level ≥12 IU/L
- •Previous poor ovarian response, defined as prior IVF cycle cancelled for poor response, or ≤4 oocytes retrieved
- •IVF for pre-implantation genetic diagnosis (PGD) or fertility preservation
- •Diabetes mellitus or uncontrolled thyroid disease
- •Abnormal uterine cavity, such as unresected submucosal fibroids, uterine septum, Mullerian anomaly such as bicornuate or unicornuate uterus or intrauterine adhesions
- •Hydrosalpinx that has not been removed or surgically ligated
- •Any contraindication to endometrial biopsy
- •Office hysteroscopy or other uterine procedure planned or performed during cycle preceding IVF stimulation
- •Use of surgically retrieved sperm
研究组 & 干预措施
Without Biopsy
Those proceeding with in vitro fertilization routinely, without an endometrial biopsy.
Endometrial Biopsy
Endometrial biopsy performed within 5-10 days prior to starting controlled ovarian stimulation, as part of in vitro fertilization treatment.
干预措施: Endometrial Biopsy (Device)
结局指标
主要结局
Clinical Pregnancy Rate
时间窗: Five weeks gestation, as dated from the egg retrieval
Clinical pregnancy rate, defined as transvaginal ultrasound documentation of fetal heartbeat at five weeks gestation.
次要结局
- Endometrial Pattern(Day of administration of human chorionic gonadotropin (8-12 days into ovarian stimulation))
- Live Birth Delivery Rate(Within twelve months of the cycle start date)
- Percentage of subjects with embryos cryopreserved(At the latest, day 6 after egg retrieval)
- Fertilization Rate(24 hours after egg retrieval)
- Implantation Rate(Five weeks gestation, as dated from the egg retrieval)
- Normal Fertilization Rate(24 Hours from egg retrieval)
- Endometrial Thickness(Day of administration of human chorionic gonadotropin (8-12 days into ovarian stimulation))
- The number of embryos cryopreserved per subject(At the latest, day 6 after egg retrieval)
研究者
Jon Havelock
Principal investigator
Pacific Centre for Reproductive Medicine