NCT04549116已完成3 期
A Multicenter, Randomized, Controlled, Double-blind, Double-dummy Study to Evaluate the Safety and Efficacy of Subcutaneous Progesterone Compared to Vaginal Progesterone for Luteal Phase Supplementation in Modified Natural Frozen Euploid Blastocyst Transfer.
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
- 688
- 试验地点
- 24
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
This is a multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority clinical study in women aged 35 to 42 years. This study will investigate the safety and efficacy of Progesterone-IBSA to support euploid embryo blastocyst implantation and early pregnancy after frozen embryo transfer (FET) in a modified natural cycle as a treatment for infertile women. Subjects will be randomized to receive either active Progesterone-IBSA or Crinone 8% for luteal and early pregnancy support and these two groups will be compared.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind, double-dummy.
入排标准
- 年龄范围
- 35 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •subject has given written informed consent;
- •Premenopausal women 35 to 42 years of age at the time of consent (at least 35 [including day of birthday] and no more than 42 [up to the day before their 43rd birthday]);
- •Valid indication for IVF treatment (i.e. history of infertility according to ASRM definition, single women or same-sex couples);
- •Consistent, regular spontaneous ovulatory menstrual cycle with normal length (24-38 days included);
- •Body mass index (BMI) < 38 kg/m2;
- •Subject with at least one euploid frozen blastocyst from a previous IVF treatment cycle;
- •Less than 3 previous consecutive euploid blastocyst transfers without a life birth;
- •Baseline Follicle Stimulating Hormone (FSH) < 15 mIU/mL, and Anti Muellerian Hormone (AMH) >0.7 ng/mL (within 6 months from screening for subjects requiring a stimulation cycle to obtain a euploid embryo); and Estradiol (E2) < 90 pg/mL and Progesterone (P4)< 1.5 ng/mL at Visit 1 (for all subjects);
- •Semen used during IVF(for subjects requiring a stimulation cycle to obtain a euploid embryo) was produced by ejaculation (not surgically derived sperm) from either the partner or from a sperm donor. Donor must be 18-40 years of age at the time of collection and compliant with 21 Code of Regulations (CFR) section 1271 Subpart C;
- •Hysterosalpingography, hysteroscopy, 3D ultrasound or sonohysterogram documenting a normal uterine cavity within the last year;
- •Normal cervical cytology/High Risk human papillomavirus (HPV) testing per American College of Obstetricians and Gynecologists guidelines.
排除标准
- •Oligo or anovulation (spontaneous menses > 39 days apart);
- •Breastfeeding or Pregnancy;
- •Contraindication to pregnancy (i.e. an active, uncontrolled clinically significant medical condition or abnormality of the sexual organs determined by the provider);
- •Known family history of major congenital anomalies;
- •Moderate to severe current endometriosis (stage 3 or 4);
- •Presence of a unilateral or bilateral hydrosalpinx that communicates with the uterus, that has not been ligated prior to treatment;
- •Recurrent pregnancy loss (RPL) as defined by the American Society of Reproductive Medicine (ASRM) as two or more consecutive failed clinical pregnancies;
- •Presence of a submucosal or intramural fibroid > 4 cm which distorts the uterine cavity or are > 5 cm in diameter;
- •Untreated uterine pathology that could impair embryo implantation (i.e. scarring/Asherman's syndrome or intra uterine polyps > 1 cm in size);
- •Type 1 or 2 diabetes mellitus based on American Diabetes Association (ADA) criteria3;
- •Uncontrolled adrenal or thyroid dysfunction;
- •History of conditions (i.e. toxic shock syndrome) that would contraindicate use of a vaginal progesterone product;
- •Subjects with hepatic impairment (liver function tests > 2x upper limit of normal);
- •Subjects with renal impairment (estimated creatinine clearance <60 mL/min/1.73 m2);
- •History of an active or treated autoimmune disease (i.e. systemic lupus erythematosus);
- •History of arterial disease (i.e. Prior or active thrombophlebitis, thromboembolic disorder or known thrombophilia);
- •Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
- •High grade cervical dysplasia;
- •Undiagnosed vaginal bleeding (i.e. at the time of screening);
- •Use of donor eggs or plans to use a gestational carrier;
- •Use of endometrial receptivity array (ERA) test to postpone or anticipate the embryo transfer (ET) day;
- •Use of epididymal, testicular , electro-ejaculated or chemotherapy exposed sperm;
- •Known allergy to progesterone preparations or their excipients;
- •Current dependence on alcohol, tobacco (must not be smoking/using tobacco x 2 months before the study) or drugs or psychotropic medications labeled as Pregnancy Categories D and X;
- •Use of concomitant medications within 1 month previous the start of the FET cycle preparation up to gestational week 12 that might interfere with the study evaluation (use of insulin sensitizing agents, vaginal medications/preparations, any drugs for luteal support other than those specified in the protocol, aspirin, any hormonal treatment, with the exception of levothyroxine);
- •Participation in a concurrent clinical trial or in another investigational drug trial within the past 2 months-
研究组 & 干预措施
Comparator
Active Comparator
Crinone 8%, 90 mg, QD intravaginally and Progesterone-IBSA Placebo, BID SC Injection every 12 hours
干预措施: Progesterone Vaginal Gel with Applicator (Drug)
Investigational
Experimental
Progesterone-IBSA 25mg, twice daily (BID) subcutaneous (SC) injection every 12 hours and Crinone Placebo, once daily (QD) intravaginally.
干预措施: Progesterone-IBSA Injectable Solution (Drug)
Investigational
Experimental
Progesterone-IBSA 25mg, twice daily (BID) subcutaneous (SC) injection every 12 hours and Crinone Placebo, once daily (QD) intravaginally.
干预措施: Placebo Vaginal gel with applicator (Drug)
Comparator
Active Comparator
Crinone 8%, 90 mg, QD intravaginally and Progesterone-IBSA Placebo, BID SC Injection every 12 hours
干预措施: Placebo injectable solution (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: 5 weeks post-embryo transfer
defined by the presence of an intrauterine fetal heart beat
Ongoing pregnancy
时间窗: 10 weeks post-embryo transfer
defined by the presence of an ongoing intrauterine pregnancy with fetal heart beat
次要结局
- Positive pregnancy rate(10+/-2 days after embryo transfer.)
- Implantation rate(6 weeks after embryo transfer,)
- Delivery rate(2-4 weeks post expected delivery date.)
- Live birth rate(2-4 weeks post expected delivery date.)
- Cycle cancellation rate (with reason)(from treatment start until 10 weeks of pregnancy)
- Adverse Events related to the mother(from Informed consent signature until 2-4 week after delivery.)
- Local tolerability(from the 4th day of treatment administration until 10 weeks post embryo transfer.)
- Early Miscarriage rate(from 5 weeks post embryo transfer until the 12th week of pregnancy.)
- Late miscarriage rate(after the 12th week of pregnancy until delivery.)
- Ectopic pregnancy rate(from 5 weeks post embryo transfer until the 12th week of pregnancy.)
- Adverse events related to the newborn.(2-4 weeks after expected delivery.)
研究者
研究点 (24)
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