Clinical trial · Interventional
Letrozole Versus Clomifene Citrate for Ovulation Induction
Double Blind Cross-over Randomized Controlled Trial Comparing Letrozole Versus Clomifene Citrate for Ovulation Induction in Women With Polycystic Ovarian Syndrome
NCT00478504CI-TRIAL-00024500completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infertility | — | UNRESOLVED | — |
| Polycystic Ovarian Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clomifene citrate | Drug | — | UNRESOLVED |
| Letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Clomiphene citrate
- description
- 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
- interventionNames
- Drug: Clomifene citrate
- type
- ACTIVE_COMPARATOR
- label
- Letrozole
- description
- 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
- interventionNames
- Drug: Letrozole
Primary outcomes (1)
- measure
- Pregnancy rate
- timeFrame
- 14 moths
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 39 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age: 18 - 39 2. BMI \< 36 3. Infertility due to anovulation 4. PCOS: At least two of the following diagnostic criteria of: 1. Oligo/amenorrhoea 2. Hyperandrogenaemia: biochemical (testosterone ≥2.5 nmol/l or free androgen index (FAI) ≥ 5) or clinical (acne/hirsutism) evidence 3. USS evidence of PCO (either ≥12 follicles measuring 2-9 mm in diameter, or an ovarian volume of \> 10 ml) 5. No recent (within 6 months) treatment for induction of ovulation 6. Normal semen analysis (WHO 1999) 7. Proven patency of at least one Fallopian tube Exclusion Criteria: 1. Inability to give informed consent 2. Contraindication to letrozole or clomifene citrate 3. Absence of any inclusion criteria
References
Publications (1)
- DERIVEDAmer 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. PMID 28854590