Letrozole Versus Hormonal Preparation in Frozen Cycles of PCOS Patients. Randomized Controlled Study

DSREC-09/2020_16

One of the indications of freezing is to reduce the risk of ovarian hyperstimulation syndrome particularly in polycystic ovarian disease (PCOS) women. Very few RCTs addressed the issue of optimizing the endometrium for a frozen cycle. Interestingly, Letrozole for ovarian stimulation showed significantly better reproductive outcome when compared with hormone replacement therapy (HRT) cycle. In addition, HRT cycle has been associated with higher miscarriage rate when compared with natural cycle frozen embryo transfer. Nevertheless, there is not yet a well-designed prospective randomized study comparing letrozole and HRT in PCOS women undergoing frozen embryo transfer.

2023-08-01

2024-02-01

2024-04-01

Withdrawn

Early phase I

Inclusion Criteria: * Women with PCOS diagnosed with Rotterdam criteria. * Age between 20 to 40-year-old * Undergoing frozen oocytes intracytoplasmic sperm injection transfer or frozen embryo transfer * Willingly accept to participate in the study Exclusion Criteria: * Women \> 40 years old or younger than 20. * Uterine pathology that decreases the chance of pregnancy or increases risk of miscarriage such as * Uterine fibroids (sub-mucous of any size or intramural of \> 3 cm) * Uncontrolled endocrinal-pathological disease like * Cushing syndrome, * Adrenal hyperplasia, * Hyperprolactinemia, * Acromegaly, * Thyroid disease, * Diabetes mellitus, and * Immune disorders. * Presence of Hydrosalpinx * Not willing or able to sign the consent form.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2024-02-20