Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer.

Launched by IBSA INSTITUT BIOCHIMIQUE SA · Sep 8, 2020

Keywords

ClinConnect Summary

This clinical trial is looking to see how well a medication called Progesterone-IBSA works in helping women who have had frozen embryos transferred to achieve pregnancy. Specifically, the study is focused on women aged 35 to 42 who are experiencing infertility and have at least one healthy frozen embryo. Participants will be randomly assigned to receive either the new medication or a standard treatment called Crinone 8%. The goal is to determine if Progesterone-IBSA is just as effective as Crinone in supporting early pregnancy after the embryo transfer.

To join the study, women must meet certain criteria, including being premenopausal, having a regular menstrual cycle, and having a body mass index (BMI) of less than 38. They should also have a normal uterine cavity and a history of infertility that qualifies them for in vitro fertilization (IVF) treatment. Participants can expect to receive either medication for support and will be monitored throughout the process. It's important to note that this trial is currently recruiting participants, and those interested should discuss their eligibility with their healthcare provider.

Gender

FEMALE

Eligibility criteria

• 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 human papillomavirus (HPV) testing per American College of Obstetricians and Gynecologists guidelines.
• Exclusion Criteria:
• • 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-