NCT04549116

进行中（未招募）

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.

IBSA Institut Biochimique SA22 个研究点分布在 1 个国家目标入组 680 人2022年10月12日

干预措施Progesterone-IBSA Injectable Solution Placebo Vaginal gel with applicator Progesterone Vaginal Gel with Applicator Placebo injectable solution

概览

阶段: 3 期
干预措施: Progesterone-IBSA Injectable Solution
疾病 / 适应症: Infertility
发起方: IBSA Institut Biochimique SA
入组人数: 680
试验地点: 22
主要终点: Clinical pregnancy rate
状态: 进行中（未招募）
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2022年10月12日

结束日期

2026年6月30日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

Female

研究者

发起方

IBSA Institut Biochimique SA

责任方

Sponsor

入排标准

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;

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;

研究组 & 干预措施

Investigational

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

Investigational

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

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

Comparator

Crinone 8%, 90 mg, QD intravaginally and Progesterone-IBSA Placebo, BID SC Injection every 12 hours

干预措施: Placebo injectable solution

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.)