Letrozole High Dose (10 mg) Compared to Letrozole Low Dose( 5 mg) for Ovarian Stimulation in Infertile Women With Polycystic Ovary Syndrome

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
Atotal number of 86 eligible PCOS women will be randomized to either letrozole 10 mg for5 days or letrozole 5 mg for 5 days for ovulation induction. The experimental arm (p1)will be treated with letrozole 10 mg for 5 days. The comparator arm (p2) will receiveletrozole 5 mg for 5 days (Tab letrol 2.5mg ‐Renata Pharmaceutical. Treatment will startfrom the 2nd day of menstruation cycle or withdrawal bleeding after the baseline visitand investigations.Ovarian response will be assessed by trans‐vaginal monitoring of follicle growth aroundday 10 of menstrual cycle.The presence of preovulatory follicle, multifolliculardevelopment, the number of developing follicles, size of largest follicle and endometrialthickness with pattern will be assessed. The woman will then be advised to test for LHsurge by urinary LH kit daily until positive and when positive will have intercourse fortwo days. She will have serum progesterone estimation after 7 days. She will repeat samedose of ovulation induction if she has menstruation and if there are no symptoms of sideeffect regarding letrozole intake or will do pregnancy test if she misses period. Ifmissed period occurs further visit will be required for serum β‐hCG estimation forconfirmation of pregnancy. If pregnancy test is positive she will do an USG for fetalcardiac motion around 7‐8 weeks.If B‐hCG negative I will give the woman Tab.Norethisterone (5mg) (Tab. Normens 5mg ‐ Renata pharmaceuticals) for (7‐10) days forwithdrawal bleeding. After withdrawal bleeding I will give her previous dose letrozole.In that situation she will define as a case of anovulation. If cyst appears I will do aTransvaginal sonography of that woman in D2 of the cycle to observe the cyst. If cystpersist, I will hold stimulation in that cycle. If cyst disappear I will givestimulation. All subject will receive drugs (Tab. Letrol 2.5mg, Tab. Normens 5mg) fromme. I will ensure their proper intake by cell phone and during their visit they will showtheir blank strip of drug for confirmation. The cumulative data will be subjected toanalysis. by Statistical Package for Social Sciences version 27 for Windows (SPSS Inc.,Chicago, Illinois, USA).
Epistemonikos ID: e4f30fa33e36786960061708c737f9889d9d95af
First added on: Aug 12, 2026