InfertilityPhase 4NCT00478504
Letrozole Versus Clomifene Citrate for Ovulation Induction
A Phase 4 study testing Letrozole and Clomifene citrate in people with Infertility and Polycystic Ovarian Syndrome, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The primary aim of the study is to assess the efficacy of letrozole as an ovulation induction agent and to test the hypothesis that letrozole will generate better pregnancy rates with fewer multiple pregnancies and higher live birth rate than the current standard agent, clomifene citrate in anovular infertile women… Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Infertility, Polycystic Ovarian Syndrome
- What is being tested?
- Letrozole and Clomifene citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2007to Sep 2014
- Phase
- Phase 4
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 - 39
- BMI < 36
- Infertility due to anovulation
- PCOS: At least two of the following diagnostic criteria of:
- Oligo/amenorrhoea
- Hyperandrogenaemia: biochemical (testosterone ≥2.5 nmol/l or free androgen index (FAI) ≥ 5) or clinical (acne/hirsutism) evidence
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- USS evidence of PCO (either ≥12 follicles measuring 2-9 mm in diameter, or an ovarian volume of > 10 ml)
- No recent (within 6 months) treatment for induction of ovulation
- Normal semen analysis (WHO 1999)
- Proven patency of at least one Fallopian tube
Who cannot join
- Inability to give informed consent
- Contraindication to letrozole or clomifene citrate
- Absence of any inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind Cross-over Randomized Controlled Trial Comparing Letrozole Versus Clomifene Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome
The primary aim of the study is to assess the efficacy of letrozole as an ovulation induction agent and to test the hypothesis that letrozole will generate better pregnancy rates with fewer multiple pregnancies and higher live birth rate than the current standard agent, clomifene citrate in anovular infertile women with polycystic ovarian syndrome.
- Conditions
- Infertility, Polycystic Ovarian Syndrome
- Being tested
- Letrozole, Clomifene citrate
- Keywords
- anovulation, ovulation induction,, polycystic ovarian syndrome, clomifene citrate, letrozole
- Medical subject headings
- Infertility, Polycystic Ovary Syndrome, Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5 mg daily if there is no response to 2.5 mg
Clomifene citrateDrug
Starting daily dose 50 mg on menstrual cycles days 2 to 6, to be increased to 100 mg daily if there is no response to 50 mg
| Study group | Role | What they receive |
|---|---|---|
| Clomiphene citrate | Active comparator | Starting daily dose 50 mg on menstrual cycles days 2 to 6, to be increased to 100 mg daily if there is no response to 50 mg Receives: Drug: Clomifene citrate |
| Letrozole | Active comparator | Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5 mg daily if there is no response to 2.5 mg Receives: Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Measured: 14 moths
Secondary outcomes (1)
1. Ovulation rate 2. Number of growing and mature follicles during treatment 3. Miscarriage rate 4. Live-birth rate 5. Multiple pregnancy rate 6. Endometrial thickness
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2014
- Study completionSep 2014
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 InfertilityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals of Derby and Burton NHS Foundation Trust
- Responsible party
- Principal investigator, Saad Amer, University of Nottingham
- Investigators
- Saad Amer, MD, MRCOG, Principal investigator, University of Nottingham and Derby Hospitals NHS foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478504
- Sponsor's protocol ID
- RD-5103-015-06
- Other IDs
- EudraCT No: 2006-006514-15
- Status last verified
- Oct 2016
- First submitted
- 23 May 2007
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Amer SA, Smith J, Mahran A, Fox P, Fakis A. Double-blind randomized controlled trial of letrozole versus clomiphene citrate in subfertile women with polycystic ovarian syndrome. Hum Reprod. 2017 Aug 1;32(8):1631-1638. doi: 10.1093/humrep/dex227.
PubMed 28854590
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Cross-over Randomized Controlled Trial Comparing Letrozole Versus Clomifene Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT00478504
- Acronym / sponsor ID
- RD-5103-015-06
- Conditions
- Infertility, Polycystic Ovarian Syndrome
- Keywords
- anovulation, ovulation induction,, polycystic ovarian syndrome, clomifene citrate, letrozole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- University Hospitals of Derby and Burton NHS Foundation Trust
- Study start
- May 2007
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 May 2007 (estimated)
- 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.
The primary aim of the study is to assess the efficacy of letrozole as an ovulation induction agent and to test the hypothesis that letrozole will generate better pregnancy rates with fewer multiple pregnancies and higher live birth rate than the current standard agent, clomifene citrate in anovular infertile women with polycystic ovarian syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clomiphene citrate | Active comparator | Drug: Clomifene citrateStarting daily dose 50 mg on menstrual cycles days 2 to 6, to be increased to 100 mg daily if there is no response to 50 mg |
| Letrozole | Active comparator | Drug: LetrozoleStarting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5 mg daily if there is no response to 2.5 mg |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age: 18 - 39
- BMI < 36
- Infertility due to anovulation
- PCOS: At least two of the following diagnostic criteria of:
- No recent (within 6 months) treatment for induction of ovulation
Key exclusion criteria (3 listed)
- Inability to give informed consent
- Contraindication to letrozole or clomifene citrate
- Absence of any inclusion criteria
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 |
|---|---|---|
| LetrozoleStarting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5 mg daily if there is no response to 2.5 mg | Drug | Letrozole |
| Clomifene citrateStarting daily dose 50 mg on menstrual cycles days 2 to 6, to be increased to 100 mg daily if there is no response to 50 mg | Drug | Clomiphene citrate |
Primary outcome
Pregnancy rate
Time frame: 14 moths
1 secondary outcome
1. Ovulation rate 2. Number of growing and mature follicles during treatment 3. Miscarriage rate 4. Live-birth rate 5. Multiple pregnancy rate 6. Endometrial thickness
Time frame: 14 months
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 28 Oct 2016.
- Derived from this study: PubMed 28854590Amer SA, Smith J, Mahran A, Fox P, Fakis A. Double-blind randomized controlled trial of letrozole versus clomiphene citrate in subfertile women with polycystic ovarian syndrome. Hum Reprod. 2017 Aug 1;32(8):1631-1638. doi: 10.1093/humrep/dex227.
- Related InfoLink provided by the sponsor.
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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.
Saad Amer, MD, MRCOG principal investigator
University of Nottingham and Derby Hospitals NHS foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Letrozole and Clomifene citrate in people with Infertility and Polycystic Ovarian Syndrome, run by University of Nottingham at 1 site in United Kingdom.
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 10 inclusion and 3 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 28 Oct 2016. 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 United Kingdom. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: 14 moths). 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 NCT00478504, 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 28 Oct 2016; AzTrials last refreshed its copy on 30 Oct 2026.