Clinical trial · Interventional
Letrozole for Frozen Embryo Transfer (FET) in Patients With Polycystic Ovary Syndrome (PCOS)
Endometrial Preparation Using Letrozole Compared to Artificial Cycle for Frozen Embryo Transfer in PCOS Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Practical issues
Summary
Brief summary (as posted)
To offer patients with oligomenorrhoea or amenorrhoea an alternative to frozen embryo transfer in an artificial cycle, endometrial preparation using letrozole may be a valuable option. Letrozole, a potent, reversible nonsteroidal aromatase inhibitor with relatively short half-life, can successfully induce ovulation without any adverse anti-estrogenic effects and thus without affecting the endometrium. The use of letrozole typically results in monofollicular growth and this reduces the effect of supraphysiological levels of estrogen on the endometrium and embryo. The purpose of this study is to compare a frozen-thawed embryo transfer in an artificial cycle with a letrozole-induced ovulatory cycle, specifically in PCOS patients. The primary outcome is early pregnancy loss.
Conditions
Conditions (4)
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, Female | — | UNRESOLVED | — |
| IVF | — | UNRESOLVED | — |
| Ovulation Disorder | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| estradiol valerate | Drug | — | UNRESOLVED |
| Letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Hormonal Replacement Therapy
- description
- Artificial preparation of the endometrium using estradiol valerate 2mg 3x/day, and vaginal micronized progesterone 2x 400mg/day.
- interventionNames
- Drug: estradiol valerate
- type
- EXPERIMENTAL
- label
- Letrozole
- description
- Using letrozole for ovulation induction before planning the frozen embryo transfer
- interventionNames
- Drug: Letrozole
Primary outcomes (1)
- measure
- early pregnancy loss
- timeFrame
- 12 weeks after frozen embryo transfer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Age more than or equal to 18 and less than or equal to 40 * BMI more than or equal to 18 and less than or equal to 35 * Diagnosis of PCOS according to Rotterdam criteria * Normal gynaecological ultrasound \< 6 months before inclusion * Signed informed consent form * Day 5 or 6 frozen-thawed embryo transfer, blastocyst stage Exclusion Criteria: * Recurrent implantation failure * Recurrent miscarriage * Presence of adenomyosis * Untreated intrauterine pathology * rAFS (revised American Fertility Society) Grade III or IV endometriosis * Hydrosalpinx * In vitro maturation (IVM) * Untreated autoimmune disorders * (History of) malignancy * Allergy or reaction to the use of progynova, utrogestan and/or letrozole in the past * Pre-implantation genetic testing (PGT)
References
Publications (0)
Data not yet available