Polycystic Ovary SyndromePhase 2/3NCT05702957
Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome
A Phase 2/3 study testing letrozole 2.5mg-7.5mg and Clomiphene Citrate 50mg-150mg in people with Polycystic Ovary Syndrome and Infertility, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Infertility
- What is being tested?
- letrozole 2.5mg-7.5mg and Clomiphene Citrate 50mg-150mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 sitePakistan
- Study dates
- Sep 2016to Dec 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women age between 18-40 years.
- Normal husband semen analysis.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Services Institute of Medical sciences
Lahore, Punjab Province, 54000
About this study
Official title: Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome: Randomised Control Trial
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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome, Infertility
- Being tested
- letrozole 2.5mg-7.5mg, Clomiphene Citrate 50mg-150mg
- Keywords
- polycystic ovary syndrome, Infertility, Clomiphene citrate, Letrozole
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
letrozole 2.5mg-7.5mgDrug
Also called tab lezra 2.5-7.5mg
Tab letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses.
Clomiphene Citrate 50mg-150mgDrug
Also called tab clomid 50-150mg
Tab clomiphene citrate 50-150mg per day for 5 days started from 2nd day of menses.
| Study group | Role | What they receive |
|---|---|---|
| letrozole | Experimental | Patients were given letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses. Receives: Drug: letrozole 2.5mg-7.5mg |
| Clomiphene citrate | Active comparator | Patients were given clomiphene citrate 50-150mg per day for 5 days started from 2nd day of the menses. Receives: Drug: Clomiphene Citrate 50mg-150mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Total number of patients conceived after treatment
Measured: 5th week of cycle when periods missed
Secondary outcomes (7)
ovulation rate
when follicle achieved diameter of 18-20mm,HCG given,ovulation confirmed by day 21 progesterone.
Measured: 10-22 day of cycle
Live birth rate
total number of live births divided by total number of patients in a group
Measured: 9 months
Monofollicular development
when only one follicle achieve diameter of greater than or equal to 18mm
Measured: 10-12 day of menstrual cycle
Multifollicular development
when 2 or more follicles achieve diameter of >12mm
Measured: 10-12 day of menstrual cycle
Miscarraige
spontaneous loss of pregnancy before 24 weeks of gestation
Measured: Less than 24weeks
Adverse effects
hot flushes.
Measured: first 10days of cycle
Adverse effects
Fatigue and dizziness
Measured: first 10days of cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study startSep 2016
- Primary completionOct 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tayyiba Wasim, Services Institute of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702957
- Sponsor's protocol ID
- IRB/2015/209/SIMS
- Status last verified
- Jan 2023
- First submitted
- 8 Dec 2022
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wasim T, Nasrin T, Zunair J, Irshad S. Efficacy of Letrozole vs Clomiphene Citrate for induction of ovulation in women with polycystic ovarian syndrome. Pak J Med Sci. 2024 Jan-Feb;40(1Part-I):78-83. doi: 10.12669/pjms.40.1.7971.
PubMed 38196458
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome: Randomised Control Trial
- ClinicalTrials.gov ID
- NCT05702957
- Acronym / sponsor ID
- IRB/2015/209/SIMS
- Conditions
- Polycystic Ovary Syndrome, Infertility
- Keywords
- polycystic ovary syndrome, Infertility, Clomiphene citrate, Letrozole
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Study start
- Sep 2016 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| letrozole | Experimental | Drug: letrozole 2.5mg-7.5mgPatients were given letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses. |
| Clomiphene citrate | Active comparator | Drug: Clomiphene Citrate 50mg-150mgPatients were given clomiphene citrate 50-150mg per day for 5 days started from 2nd day of the menses. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women age between 18-40 years.
- Normal husband semen analysis.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| letrozole 2.5mg-7.5mgAlso: tab lezra 2.5-7.5mgTab letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses. | Drug | letrozole |
| Clomiphene Citrate 50mg-150mgAlso: tab clomid 50-150mgTab clomiphene citrate 50-150mg per day for 5 days started from 2nd day of menses. | Drug | Clomiphene citrate |
Primary outcome
Pregnancy rate
Time frame: 5th week of cycle when periods missed
Total number of patients conceived after treatment
7 secondary outcomes
ovulation rate
Time frame: 10-22 day of cycle
Live birth rate
Time frame: 9 months
Monofollicular development
Time frame: 10-12 day of menstrual cycle
Multifollicular development
Time frame: 10-12 day of menstrual cycle
Miscarraige
Time frame: Less than 24weeks
Adverse effects
Time frame: first 10days of cycle
Adverse effects
Time frame: first 10days of cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Derived from this study: PubMed 38196458Wasim T, Nasrin T, Zunair J, Irshad S. Efficacy of Letrozole vs Clomiphene Citrate for induction of ovulation in women with polycystic ovarian syndrome. Pak J Med Sci. 2024 Jan-Feb;40(1Part-I):78-83. doi: 10.12669/pjms.40.1.7971.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing letrozole 2.5mg-7.5mg and Clomiphene Citrate 50mg-150mg in people with Polycystic Ovary Syndrome and Infertility, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate (time frame: 5th week of cycle when periods missed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05702957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.