Cabergoline & Letrozole Versus Letrozole in Ovulation Induction in PCOS
NCT ID: NCT07255911
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
72 participants
INTERVENTIONAL
2025-02-07
2026-06-30
Brief Summary
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Participants will:
experimental group will receive Cabergoline and Letrozole comparator group will receive letrozole alone TVS Monitoring will be done for 3 cycle for ovarian response
Detailed Description
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After fulfilling the inclusion and exclusion criteria participants will be allocated to experimental group ( group A : combined cabergoline and letrozole) or comparator group( group B : letrozole only). Randomization will be done between group A and group B. The random sequence generation will be done by permuted blocks randomized with computer generated random numbers. Allocation concealment will be done by serially numbered opaque sealed envelope. Each envelop will be labeled with a serial number and will have a card inside noting the intervention type. Allocation will never be changed after opening the closed envelops.
First Cycle :
Purpose and procedure of study will be discussed with the participant and informed written consent (Appendix II) will be obtained to participate in the study. Detailed socio-demographic data, history, clinical examination and investigations will be recorded in a predesigned data sheet.
Treatment will be started from the 2nd day of menstruation/withdrawal bleeding after the baseline visit and investigations. Experimental group participants will receive tab cabergoline 0.5 mg (1 tablet at night) on day 2 and day 9 of cycle plus letrozole 5 mg/day ( 2 tablet at night)for consecutive 5 days starting from the day 2 of menstrual cycle or withdrawal bleeding. Participants in the comparator group will receive only letrozole 5 mg/day (2 tablet at night) for consecutive 5 days starting from the day 2 of menstrual cycle or withdrawal bleeding. All participants will be instructed not to take any medications during the trial except after consultation with primary investigator.
Ovarian response of both groups will be assessed by transvaginal monitoring of follicle growth(presence of pre ovulatory follicles \& largest follicle size) on12th day of cycle done by same operator. Responders will be defined as participants who will develop pre ovulatory follicles of ≥ 14 mm. The participants will then be advised to test for ovulation by urinary LH kit daily until positive. She will inform the investigator over cellphone and will do timed intercourse next two days. Confirmation of ovulation will be done by measuring mid-luteal (day 21) serum progesterone measurement.She will again come to our department for serum progesterone estimation and then I will collect 5ml of blood in EDTA mixed test tube at morning time \& will send it to biochemistry lab for estimation. Serum progesterone ≥ 3 ng/ml will be considered as ovulation. At least four follow up visits will be needed each month, one visit for baseline assessment, one for ovulation induction, one visit for folliculometry and one for serum progesterone estimation to confirm ovulation. Further visits will be needed after missed period 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.
Second cycle :
Assessment of clinical profile, compliance with drug and side effects. If participant can tolerate Experimental group will receive tab cabergoline 0.5 mg 1 tablet at night on day 2 and day 9 of cycle plus letrozole 5 mg/day(2 tablet at night) for consecutive 5 days starting from the day 2 of menstrual cycle Comparator group will receive only letrozole 5 mg/day ( 2 tablet at night) for consecutive 5 days starting from the day 2 of menstrual cycle Further procedure will follow as same as first cycle. If participant cannot tolerate ,will be considered as drop out.
Third cycle :
Assessment of clinical profile, compliance with drug and side effects If participant can tolerate Experimental group will receive tab cabergoline 0.5 mg 1 tablet at night on day 2 and day 9 of cycle plus letrozole 5 mg/dayat night for consecutive 5 days starting from the day 2 of menstrual cycle Comparator group will receive only letrozole 5 mg/day at night for consecutive 5 days starting from the day 2 of menstrual cycle Further procedure will follow as same as first cycle. If participant can not tolerate ,will be considered as drop out.
For each and every subject separate clinical record form will be prepared. Data will be collected from the patients on different visits on variables of interest using interview, observation, clinical examination, investigations and from the history sheet of the patients. The cumulative data will be subjected to analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental arm : Cabergoline and letrozole
participants will receive Tab. cabergoline 0.5 mg 1 tablet at night, two dose at weekly interval (day 2 and day 9 of menstruation/withdrawal bleeding) plus tab. letrozole 5 mg/day at night from day 2 menstruation/withdrawal bleeding for 5 days for consecutive 3 cycles.
Cabergoline 0.5 mg
Tab. cabergoline 0.5 mg 1 tablet at night, two dose at weekly interval (day 2 and day 9 of menstruation/withdrawal bleeding) plus Tab. letrozole 5 mg/day at night from day 2 of menstruation/withdrawal bleeding for 5 days for consecutive 3 cycles.
Comparator arm : letrozole
participants will receive Tab. letrozole 5 mg/day at night from day 2 of menstruation/withdrawal bleeding for 5 days for consecutive 3 cycles.
Letrozole 0.5mg
Tab. letrozole 5 mg/day at night from day 2 menstruation/withdrawal bleeding for 5 days for consecutive 3 cycles.
Interventions
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Letrozole 0.5mg
Tab. letrozole 5 mg/day at night from day 2 menstruation/withdrawal bleeding for 5 days for consecutive 3 cycles.
Cabergoline 0.5 mg
Tab. cabergoline 0.5 mg 1 tablet at night, two dose at weekly interval (day 2 and day 9 of menstruation/withdrawal bleeding) plus Tab. letrozole 5 mg/day at night from day 2 of menstruation/withdrawal bleeding for 5 days for consecutive 3 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age: 18-35 years.
3. Primary or secondary subfertility.
4. Selected for ovulation induction.
Exclusion Criteria
2. Serum prolactin (more than 50 ng/ml) (Kyritsi et al., 2018).
3. Male factor infertility.
4. Women with other infertility factors (endometriosis, PID,uterine \& tubal causes of infertility).
5. Uncontrolled Medical disease (DM, HTN, kidney disease, liver disease).
6. History of hypersensitivity to cabergoline \& letrozole.
7. Thyroid dysfunction ( serum TSH ≥5mIU/L)
8. BMI:\< 18.5 kg/m2 and ≥30 kg/m2.
9. Patients on metformin therapy.
10. Patient on antiemetic like Domperidone metoclopramide, antipsychotic drug like haloperidol and risperidone, tricyclic antidepressant like amitriptyline, clomipramine, antihypertensive like verapamil, methyldopa, reserpine.
18 Years
35 Years
FEMALE
No
Sponsors
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Bangladesh Medical University
OTHER
Mst.Sumyara Khatun
OTHER
Responsible Party
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Mst.Sumyara Khatun
Medical Officer
Locations
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Bangladesh Medical University
Dhaka, Shahbag, Bangladesh
Countries
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Central Contacts
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Facility Contacts
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References
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Delcour C, Robin G, Young J, Dewailly D. PCOS and Hyperprolactinemia: what do we know in 2019? Clin Med Insights Reprod Health. 2019 Sep 9;13:1179558119871921. doi: 10.1177/1179558119871921. eCollection 2019.
Melmed S, Casanueva FF, Hoffman AR, Kleinberg DL, Montori VM, Schlechte JA, Wass JA; Endocrine Society. Diagnosis and treatment of hyperprolactinemia: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Feb;96(2):273-88. doi: 10.1210/jc.2010-1692.
Other Identifiers
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5385
Identifier Type: -
Identifier Source: org_study_id