NCT03565211已完成3 期
A Prospective, Multi-Center, Non-Comparative Trial of the Clinical Safety of the Progesterone Vaginal Ring in Women Undergoing Assisted Reproductive Technology (ART) Procedures
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 352
- 试验地点
- 15
- 主要终点
- Cumulative Rate of Spontaneous Abortions Occurring on or Before 12 Weeks Post-oocyte Retrieval
研究概览
简要总结
The purpose of the study is to assess the safety of Progesterone Vaginal Ring (PVR) in women undergoing fresh embryo transfer (ART).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-label trial
入排标准
- 年龄范围
- 18 Years 至 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-menopausal women aged 18-34 at the time of consent.
- •Documentation of a normal uterine cavity by hysteroscopy, hydrosonogram, or hysterosalpingogram within one year of screening.
- •Normal Pap smear test within 24 months of screening.
- •At least one cycle without reproductive hormone medication prior to screening follicle-stimulating hormone (FSH) and estradiol blood draw.
- •Tubal, idiopathic, male factor, ovulatory dysfunction, or endometriosis-linked infertility.
排除标准
- •Body mass index greater than 38 kg/m^
- •FSH greater than 15 IU/L during the early follicular phase (Day 2-4). For those participants with polycystic ovarian syndrome, a Day 2-4 FSH level can be obtained following a progestogen withdrawal or spontaneous menses.
- •Clinically significant gynecologic pathology, such as submucosal fibroids, intramural fibroids >5 cm, communicating hydrosalpinx, uncorrected uterine septum, endometrial cancer or endometrial atypia, scar tissue inside the cavity or poorly developed uterine lining from prior uterine surgery, pelvic tuberculosis, or any other conditions that could adversely affect pregnancy success.
- •Uncontrolled elevation of prolactin or too little thyroid hormone in the blood.
- •History of more than one failed fresh in vitro fertilization cycle. A failed cycle is defined as having started a cycle and not becoming pregnant or pregnancy loss prior to the 20th week of pregnancy.
研究组 & 干预措施
Progesterone vaginal ring (PVR)
Experimental
Treatment started on the day following oocyte retrieval and could be continued through Week 12 of pregnancy (10 weeks post-oocyte retrieval), depending on the participants pregnancy assessment. A new PVR was inserted every 7 days with up to 10 PVRs used.
干预措施: Progesterone vaginal ring (Drug)
结局指标
主要结局
Cumulative Rate of Spontaneous Abortions Occurring on or Before 12 Weeks Post-oocyte Retrieval
时间窗: On or before 12 weeks post-oocyte retrieval
Frequency of participants with spontaneous abortions on or before 12 weeks post-oocyte retrieval and undergoing fresh embryo transfer was presented. Spontaneous abortion was defined as two positive beta-human chorionic gonadotropin (β-hCG) tests occurring at least two days apart on or after 2 weeks post-oocyte retrieval, but followed by observation of any empty intrauterine gestational sac (blighted ovum), intrauterine gestation without a fetal heart beat, or absence of viable fetuses, as documented by transvaginal ultrasound (TVUS).
次要结局
- Cumulative Rate of Spontaneous Abortions Occurring at 10 Weeks Post-oocyte Retrieval(At 10 weeks post-oocyte retrieval)
- Positive β-hCG Rate at 2 Weeks and 2 Weeks +3-4 Days Post Oocyte Retrieval(At 2 weeks and 2 weeks +3-4 Days post oocyte retrieval)
- Clinical Pregnancy Rate at 10 Weeks(At 10 weeks post-oocyte retrieval)
- Frequency and Intensity/Grade of Vaginal Hemorrhage(From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval))
- Frequency and Intensity/Grade of Vaginal Pain(From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval))
- Frequency and Intensity/Grade of Vaginal Infection(From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval))
- Rate of Abnormal Findings in Clinical Laboratory Tests (Clinical Chemistry, Hematology, and Urinalysis)(From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval))
- Cumulative Rate of Biochemical Abortion Within 6 Weeks Post-oocyte Retrieval(Within 6 weeks post-oocyte retrieval)
- Cumulative Rate of Biochemical Abortion Within 10 Weeks Post-oocyte Retrieval(Within 10 weeks post-oocyte retrieval)
- Rate of Abnormal Findings in Vital Signs(From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval))
- Frequency and Intensity/Grade of Vaginal Irritation(From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval))
- Frequency and Reason for PVR Discontinuation(From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval))
- Cumulative Rate of Spontaneous Abortions Occurring at 6 Weeks Post-oocyte Retrieval(At 6 weeks post-oocyte retrieval)
- Clinical Pregnancy Rate at 6 Weeks(At 6 weeks post-oocyte retrieval)
- Rate of Ectopic and Heterotopic Pregnancies Following Oocyte Retrieval(At 4 weeks +3-4 Days after oocyte retrieval)
- Frequency, Intensity/Grade, Seriousness, and Relatedness of Adverse Events (AEs)(From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval))
- Frequency and Intensity/Grade of Vaginal Bleeding/Spotting(From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval))
- Frequency, Intensity/Grade, Seriousness, and Relatedness of AEs Associated With Vaginal and Cervical Abrasions and Lesions(From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval))
- Frequency, Intensity/Grade, Seriousness, and Relatedness of AEs Associated With Vaginal Adhesions(From Day 1 of PVR treatment (day after oocyte retrieval) up to end-of-trial (12 weeks post-oocyte retrieval))
研究者
研究点 (15)
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