Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer. (NCT04549116) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer.
United States680 participantsStarted 2022-10-12
Plain-language summary
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.
Who can participate
Age range35 Years – 42 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 huma…