How do Different Ovarian Stimulation Protocols Affect Endometrial Receptivity During a Fresh In-vitro Fertilization Attempt

1806-LIS-044-SD

This study will assess the change in endometrial gene expression signature on the day of embryo transfer according to the type of exogenous gonadotropins administered.

2020-01-29

2023-05-22

2023-05-22

Completed

Early phase I

24

Inclusion Criteria: 1. Informed consent form (ICF) dated and signed. 2. Age: ≥18 and ≤42 years old. 3. AFC \<20. 4. AMH \<2.5 ng/mL, performed in the 12 months prior to inclusion. 5. Body Mass Index (BMI): ≥18.5 Kg/m2 and \<30 Kg/m2. 6. Weight: ≥50 kg and \<80 kg. 7. First or second ART cycle (with pregnancy wish and planned for single blastocyst transfer) at the study site, or fertility preservation cycle. 8. Regular menstrual cycles (between 22 and 35 days). 9. Two ovaries present. Exclusion Criteria: 1. Simultaneous participation in another clinical study. 2. Previous history of poor ovarian response (\<4 oocytes retrieved) with a maximal dose of OS (≥300 IU/day) or OHSS, regardless of gonadotropin dose. 3. Known reasons for impaired implantation (i.e. hydrosalpinx, fibroid distorting the endometrial cavity, Asherman's syndrome, thrombophilia or endometrial tuberculosis). 4. Repeated miscarriages (\>2 previous biochemical pregnancies or \>2 spontaneous miscarriages). 5. Recurrent implantation failure (\>3 failed cycles with good quality embryos). 6. Polycystic ovary syndrome (PCOS). 7. Tumours of the ovary, breast, uterus, pituitary or hypothalamus. 8. Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause. 9. Ovarian cysts or enlarged ovaries. 10. Fibroid tumours of the uterus incompatible with pregnancy. 11. Malformations of the reproductive organs incompatible with pregnancy. 12. Primary gonadal failure. 13. Renal impairment defined as estimated glomerular filtration rate of 90 ml/min/1.73 m2 determined by the Modified Diet and Renal Disease (MDRD) equation at screening. 14. Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin). 15. Risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia. 16. Moderate or severe hepatic impairment. 17. Untreated and uncontrolled thyroid dysfunction. 18. Current use of oral contraceptive, anti-depressants, anti-psychotics, steroids, anti-epileptics or chemotherapy. 19. Administration of exogenous Estradiol (E2), Progesterone (P4) or gonadotropins in the preceding menstrual cycle. 20. Active female smoking. 21. Acceptors of donated oocytes/embryos. 22. Ongoing pregnancy. 23. Women who have previously enrolled in the trial. 24. Those unable to comprehend the investigational nature of the proposed study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All consenting subjects will first undergo an endometrial biopsy seven days after the luteinizing hormone (LH) peak in an unmedicated natural cycle. This biopsy will serve as the baseline endometrial biopsy (natural cycle biopsy) for the gene expression signature analysis. Following this baseline biopsy, the subjects will be randomly allocated to a specific type of ovarian stimulation regimen in order to later perform some second endometrial biopsy, five days after oocyte retrieval (stimulated cycle biopsy).', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

2023-06-01