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Completed

NCT Number: NCT05702957

Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Services Institute of Medical sciences

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

letrozole 2.5mg-7.5mg

Drug

Tab letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses.

Other names: tab lezra 2.5-7.5mg

Clomiphene Citrate 50mg-150mg

Drug

Tab clomiphene citrate 50-150mg per day for 5 days started from 2nd day of menses.

Other names: tab clomid 50-150mg

Primary outcomes

  1. Pregnancy rate

    Time frame: 5th week of cycle when periods missed

    Total number of patients conceived after treatment

Secondary outcomes

  1. ovulation rate

    Time frame: 10-22 day of cycle

    when follicle achieved diameter of 18-20mm,HCG given,ovulation confirmed by day 21 progesterone.

  2. Live birth rate

    Time frame: 9 months

    total number of live births divided by total number of patients in a group

  3. Monofollicular development

    Time frame: 10-12 day of menstrual cycle

    when only one follicle achieve diameter of greater than or equal to 18mm

  4. Multifollicular development

    Time frame: 10-12 day of menstrual cycle

    when 2 or more follicles achieve diameter of >12mm

  5. Miscarraige

    Time frame: Less than 24weeks

    spontaneous loss of pregnancy before 24 weeks of gestation

  6. Adverse effects

    Time frame: first 10days of cycle

    hot flushes.

  7. Adverse effects

    Time frame: first 10days of cycle

    Fatigue and dizziness

Sponsors and collaborators

Lead sponsor

Services Institute of Medical Sciences, Pakistan

Other Gov

Registry information

Official study title

Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome: Randomised Control Trial

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 27, 2023
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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