The Effectiveness of Swim-up Versus Gradient Density for Sperm Preparation in Patients Undergoing Intrauterine Insemination: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 912
- 试验地点
- 1
- 主要终点
- Live birth rate
研究概览
简要总结
Intrauterine insemination (IUI) is the first-line treatment for couples with unexplained and mild male factor infertility. The result of IUI depends on many factors including the sperm preparation techniques. Swim-up (SU) and Density Gradient (DG) are the two most commonly used techniques in sperm preparation for IUI. There is discussion about the effectiveness of these two techniques for IUI outcomes. The effectiveness of SU and DG methods on IUI success rate is not clearly understood and is controversial. This multicenter, randomized controlled trial will be conducted to determine which method (DG or SU) is better for IUI treatment.
详细描述
Potentially eligible patients will be given information about the study on day 2 or day 3 of the menstrual cycle, when the ovarian stimulation starts. Screening for eligibility will be performed by treating physicians on the day of IUI, after having obtained the semen qualified for inclusion criteria from the husband. Eligible participants will be invited to a full discussion with investigators about the study and will be given the informed consent form. Couples will have enough time to decide if they agree to participate in the study or not. Written informed consent will be obtained by the investigators from all couples prior to enrolment. When a participant signs an informed consent, she is considered to be enrolled in the study.
Eligible patients who have provided informed consent will be randomized in a 1:1 ratio to either SU or GD. Assignment to treatment allocation will be done via a web portal hosted by HOPE Research Center, Vietnam. The randomization schedule will be computer-generated at HOPE Research Center, with a permuted random block size of 2, 4, and 6. Blinding will not be possible due to the nature of interventions.
Ovarian stimulation will be performed by using human menopausal gonadotrophins (hMG) (IVF-M, LG Life science, Korea) and follicular development will be monitored by transvaginal ultrasound every 3 - 5 days begin on day 2 or day 3 of the menstrual cycle. An injection of human chorionic gonadotropin (hCG) (IVF-C 5000 IU, LG Life Science, Korea) will be given to trigger ovulation when the mean diameter of the dominant follicle reached ≥ 18 mm. Those who have more than 7 follicles ≥ 14 mm will be subjected to cancel or convert to IVM. IUI will be scheduled 36 - 38 hours after hCG injection.
A sperm sample will be obtained in the clinic by masturbation after 2-5 day of abstinence. Spoken and written instructions about the collection of the semen sample will be given in advance. The time between semen production and processing will be up to 1 hour. Sperm preparation will be performed after the patient agrees to participate in the study.
In couples allocated to the sperm swim-up technique (SU): the normal and highly motile sperm will move against the gravity and separate from the dead or abnormal sperms to swim up to the upper media culture layer In couples allocated to the sperm density gradient centrifugation technique (GD): the density in which mature and normal sperms are capable of passing through filtration layer to be isolated from dead or abnormal sperms in semen Prepared sperms will be transferred into uterus by soft catheter (Gynétics, Belgium). Luteal-phase support will be done with vaginal progesterone 400 mg per day (Cyclogest 200 mg, Actavis, UK) until 7th week of gestation. In both groups, clinicians who perform insemination will be blinded to the intervention.
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
- Single (Care Provider)
盲法说明
The prepared sperms will be proceeded to medical doctor who will carry the IUI and have no information about the semen preparation step.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing IUI
- •Undergone ≤ 2 previous IUI cycles
- •Progressive motility (PR) before sperm preparation: ≥ 32%
- •Sperm concentration before sperm preparation: ≥ 5 million/ml
- •Total progressive motility sperm count before sperm preparation: > 5million
- •Agree to participate in the study
排除标准
- •Using frozen semen
- •High viscosity semen
结局指标
主要结局
Live birth rate
时间窗: At 24 weeks of gestation
Live birth is defined as the complete expulsion or extraction from a woman of a product of fertilization, after 24 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown. In the analysis for the primary endpoint, twin delivery will be considered.
次要结局
- Ongoing pregnancy rate (OPR)(At the 12 weeks of gestation)
- Biochemical pregnancy rate(At 14 days after insemination)
- Total motile sperm count after sperm preparation(At 5 minutes after sperm preparation for IUI)
- High birth weight rate(At birth)
- 1-minute Apgar score(1 minute after delivery)
- Ectopic pregnancy rate(At 5-7 weeks of gestation)
- Clinical pregnancy rate(At 7 weeks of gestation)
- Miscarriage rate(Before 22 weeks of gestational age)
- Multiple pregnancy rate(At 7 weeks of gestation)
- Gestational age at delivery(At birth)
- 5-minutes Apgar score(5 minutes after delivery)
- Vanishing twin rate(In the first trimester pregnancy)
- Iatrogenic preterm birth rate(At birth)
- Low birth weight rate(At birth)
- Very high birth weight rate(At birth)
- Admission to NICU rate(7 days after delivery)
- Congenital abnormalities rate(At birth)
- Stillbirth rate(After 28 completed weeks of gestational age)
- Preterm labor rate(At birth)
- Spontaneous preterm birth rate(At birth)
- Birth weight(At birth)
- Very low birth weight rate(At birth)