Letrozole High Dose (10 mg) Compared to Letrozole Low Dose( 5 mg) for Ovarian Stimulation in Infertile Women With Polycystic Ovary Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Presence of preovulatory follicle
Study Overview
Brief Summary
The goal of this clinical trial is to learn if drug letrozole 10mg for 5 days works better than letrozole 5mg for 5 days for ovarian stimulation in infertile women with PCOS. It will also learn about the safety of drug letrozole . The main questions it aims to answer are:
What medical problems do participants have when taking drug letrozole? Researchers will compare drug letrozole 10mg for 5 days works better than letrozole 5 mg for 5 days for ovarian stimulation in infertile women with PCOS
Participants will:
The experimental arm (p1) will be treated with letrozole 10 mg for 5 days. The comparator arm (p2) will receive letrozole 5 mg for 5 days for ovulation induction for consecutive 3 months Treatment will start from the 2nd day of menstruation cycle or withdrawal bleeding after the baseline visit and investigations.
Ovarian response will be assessed by trans-vaginal monitoring of follicle growth around day 10 of menstrual cycle
Detailed Description
Atotal number of 86 eligible PCOS women will be randomized to either letrozole 10 mg for 5 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 receive letrozole 5 mg for 5 days (Tab letrol 2.5mg -Renata Pharmaceutical. Treatment will start from the 2nd day of menstruation cycle or withdrawal bleeding after the baseline visit and investigations.
Ovarian response will be assessed by trans-vaginal monitoring of follicle growth around day 10 of menstrual cycle.The presence of preovulatory follicle, multifollicular development, the number of developing follicles, size of largest follicle and endometrial thickness with pattern will be assessed. The woman will then be advised to test for LH surge by urinary LH kit daily until positive and when positive will have intercourse for two days. She will have serum progesterone estimation after 7 days. She will repeat same dose of ovulation induction if she has menstruation and if there are no symptoms of side effect regarding letrozole intake or will do pregnancy test if she misses period. If missed period occurs further visit will be required for serum β-hCG estimation for confirmation of pregnancy. If pregnancy test is positive she will do an USG for fetal cardiac 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 for withdrawal 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 a Transvaginal sonography of that woman in D2 of the cycle to observe the cyst. If cyst persist, I will hold stimulation in that cycle. If cyst disappear I will give stimulation. All subject will receive drugs (Tab. Letrol 2.5mg, Tab. Normens 5mg) from me. I will ensure their proper intake by cell phone and during their visit they will show their blank strip of drug for confirmation. The cumulative data will be subjected to analysis. by Statistical Package for Social Sciences version 27 for Windows (SPSS Inc., Chicago, Illinois, USA).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: 18-35 years old
- •BMI : 18-30 kg/m2
- •Diagnosed cases of PCOS patients according to Rotterdam criteria.
- •Corrected hypothyroidism and hyperprolactinemia
Exclusion Criteria
- •Women with other infertility factors (endometriosis, tubal and uterine causes of infertility)
- •Male factor infertility
- •Impaired hepatic or renal function
- •History of hypersensitivity to letrozole
Arms & Interventions
Tab.Letrozole 10 mg for 5 days
Tab letrozole 10 mg for 5 days from day 2-3 of menstruation/withdrawal bleeding (5mg at morning and 5mg bed time for 5 days) for 3 cycle
Intervention: Tab.Letrozole 10 mg for 5 days (Drug)
Tab.Letrozole 5 mg for 5 days
Tab letrozole 5mg for 5 days from day 2-3 of enstruation/withdrawal bleeding ( 5mg at bed time for 5 days) for three cycle
Intervention: Tab.Letrozole 5mg for 5 days (Drug)
Outcomes
Primary Outcomes
Presence of preovulatory follicle
Time Frame: 12 weeks
Preovulatory follicle:A follicle14 mm or more
Multifollicular development
Time Frame: 12 weeks
Multifollicular development: Presence of more than one preovulatory follicle
Secondary Outcomes
- Ovulation Rate(3 months)
- Pregnancy rate(3 months)
- Number of developing follicles(3 months)
- Days to LH surge(3 months)
Investigators
Mst.Sumyara Khatun
Medical Officer
Bangladesh Medical University