Clinical trial · Interventional
Letrozole Versus Hormonal Preparation in Frozen Cycles of PCOS Patients.
Letrozole Versus Hormonal Preparation in Frozen Cycles of PCOS Patients. Randomized Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): unexpected slow recruitment and change of center frozen embryo transfer protocol
Summary
Brief summary (as posted)
One of the indications of freezing is to reduce the risk of ovarian hyperstimulation syndrome particularly in polycystic ovarian disease (PCOS) women. Very few RCTs addressed the issue of optimizing the endometrium for a frozen cycle. Interestingly, Letrozole for ovarian stimulation showed significantly better reproductive outcome when compared with hormone replacement therapy (HRT) cycle. In addition, HRT cycle has been associated with higher miscarriage rate when compared with natural cycle frozen embryo transfer. Nevertheless, there is not yet a well-designed prospective randomized study comparing letrozole and HRT in PCOS women undergoing frozen embryo transfer.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Frozen Embryo Transfer | — | UNRESOLVED | — |
| Hormone Replacement Therapy | — | UNRESOLVED | — |
| Letrozole | — | UNRESOLVED | — |
| Live Birth | — | UNRESOLVED | — |
| Miscarriage | — | UNRESOLVED | — |
| Polycystic Ovarian Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letrozole 2.5mg | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PCOS women will receive letrozole ovarian stimulation.
- description
- Polycystic ovarian disease (PCOS) women undergoing frozen embryo transfer (FER) will use Letrozole 5 mg starting on day 3 of spontaneous menstrual period or after progesterone withdrawal bleeding for five consecutive days.
- interventionNames
- Drug: Letrozole 2.5mg
- type
- ACTIVE_COMPARATOR
- label
- PCOS women will receive Estradiol and Progesterone (hormonal endometrial preparation).
- description
- PCOS women will use daily Cetorelix acetate 0.25 mg injections for 5 days from day 1-3 of the menstrual follow or after progesterone (P4) withdrawal bleeding. They will commence daily oral Estradiol Valerate (E2) 2 mg twice daily for 5 days starting from day 3 of the menstrual flow or after P4 withdrawal bleeding, then-after three times daily. When endometrial thickness reaches 7 mm or more, the dose of E2 will be reduced to 4 mg/ day. Women will start using vaginal micronized P4 100 mg three times daily starting from 8PM. After 48 hours of starting the vaginal P4, oral Dydrogesterone 10 mg three times daily will commence.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria:
* Women with PCOS diagnosed with Rotterdam criteria.
* Age between 20 to 40-year-old
* Undergoing frozen oocytes intracytoplasmic sperm injection transfer or frozen embryo transfer
* Willingly accept to participate in the study
Exclusion Criteria:
* Women \> 40 years old or younger than 20.
* Uterine pathology that decreases the chance of pregnancy or increases risk of miscarriage such as
* Uterine fibroids (sub-mucous of any size or intramural of \> 3 cm)
* Uncontrolled endocrinal-pathological disease like
* Cushing syndrome,
* Adrenal hyperplasia,
* Hyperprolactinemia,
* Acromegaly,
* Thyroid disease,
* Diabetes mellitus, and
* Immune disorders.
* Presence of Hydrosalpinx
* Not willing or able to sign the consent form.References
Publications (0)
Data not yet available