Clinical trial NCT05702957: Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome
Official title: Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome: Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Polycystic Ovary Syndrome
Infertility
Keywords: polycystic ovary syndrome
Infertility
Clomiphene citrate
Letrozole
Lead sponsor: Services Institute of Medical Sciences, Pakistan
Sponsor class: OTHER_GOV
First posted: 2023-01-27
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Total 230 patients were randomized in study, divided in two groups by computer generated numbers, out of which 220 patients were analyzed. .Group-A patients were given clomiphene citrate 50-150mg per day for 5 days starting from 2nd day of menses and group B patients were given letrozole 2.5-7.5mg per day for 5 days.
Primary purpose: TREATMENT

Brief summary: It was randomised controlled study to compare the efficacy of clomiphene and letrozole in polycystic ovarian syndrome(PCOS) women with infertility.The aim was to select more appropriate treatment for ovulation induction in PCOS women.

Detailed description: The prevalence of infertility due to polycystic ovarian syndrome in Pakistan is 21.9%.It leads to an ovulation which results in infertility.The objective of this study was to compare the efficacy of letrozole vs clomiphene citrate for ovulation induction in PCOS women.Methods.It was a randomised controlled trial conducted in department of gynaecology and obstetrics ,Services Hospital Lahore from 2016-2019.

Total 230 patients were included in study, they were divided in two groups, out of which 220 patients were analysed. .Group-A patients were given clomiphene citrate 50-150mg per day for 5 days starting from 2nd day of menses and group B patients were given letrozole 2.5-7.5mg per day for 5 days. Transvaginal ultrasound monitoring done from day 10-12 of menstrual cycle to measure follicle number and size.When follicle achieved a diameter of 18-20mm, then Inj HCG(human chorionic gonadotropin)10,000 IU intramuscular was given. Ovulation was confirmed by day 21 S.progesterone. When patient conceived, they were followed up till delivery.

Eligibility criteria: Inclusion Criteria:

* Women age between 18-40 years.
* Normal husband semen analysis.

Exclusion Criteria:

* All infertile couples who had other causes of infertility than PCOS.
* Those who had recently taken these medications.
* Any contraindication to use of drugs e.g renal or hepatic dysfunction, hypersensitivity to this drug.
* BMI\>35 because obese women respond poorly to ovulation induction.

Primary outcomes:
measure: Pregnancy rate
timeFrame: 5th week of cycle when periods missed
Secondary outcomes:
measure: ovulation rate
timeFrame: 10-22 day of cycle
measure: Live birth rate
timeFrame: 9 months
measure: Monofollicular development
timeFrame: 10-12 day of menstrual cycle
measure: Multifollicular development
timeFrame: 10-12 day of menstrual cycle
measure: Miscarraige
timeFrame: Less than 24weeks
measure: Adverse effects
timeFrame: first 10days of cycle
measure: Adverse effects
timeFrame: first 10days of cycle
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Institute of Medical sciences
state: Punjab
Study officials:
References: