Comparing Letrozole and Hormone Replacement for Frozen Embryo Transfer in PCOS Women
Live Birth After Letrozole-stimulated Cycles Versus Hormone Replacement Treatment Cycles for the First Frozen Embryo Transfer in Women With PCOS: a Randomized Controlled Trial
NA · Reproductive & Genetic Hospital of CITIC-Xiangya · NCT05227391
This study is testing whether using letrozole or hormone replacement helps women with PCOS have better success with their first frozen embryo transfer during IVF.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1078 (estimated) |
| Ages | 20 Years to 38 Years |
| Sex | Female |
| Sponsor | Reproductive & Genetic Hospital of CITIC-Xiangya (other) |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT05227391 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a multicenter randomized controlled trial that aims to compare the efficacy and safety of two different endometrial preparation protocols for the first frozen embryo transfer cycle in women diagnosed with PCOS. Participants will be randomly assigned to receive either letrozole-stimulated cycles or hormone replacement treatment cycles. The study will monitor pregnancy and perinatal outcomes during this cycle to determine which method is more effective. The trial focuses on women undergoing their first cycle of IVF or ICSI with whole embryo freezing.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 20 to 38 with a diagnosis of PCOS who are participating in their first IVF or ICSI cycle and have at least one good-quality embryo for transfer.
Not a fit: Patients with a history of recurrent spontaneous abortion or significant uterine abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve pregnancy outcomes for women with PCOS undergoing frozen embryo transfer.
How similar studies have performed: Other studies have shown varying success with similar approaches, but this specific comparison of letrozole versus hormone replacement in this population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. women diagnosed with PCOS according to modified Rotterdam criteria; * 2. Women who are participating in their first cycle of IVF or ICSI. * 3. Women whose IVF/ICSI ovarian stimulation protocol was either GnRH antagonist protocol or long agonist protocol. * 4. Women with whole embryos freezing. * 5. Women aged 20 to 38 years old; * 6. Women BMI 18 kg/m2 to 30 kg/m2 * 7. Women with at least one good-quality embryo suitable for transfer, including day 3 cleavage stage embryo with grade 7CI /8CI and day 5 or day 6 blastocyst with grade 4BB or higher. Exclusion Criteria: * 1. Women who has a history of recurrent spontaneous abortion. * 2. Women with unilateral/bilateral oophorectomy. * 3. Women with untreated Hydrosalpinx. * 4. Women with a uterine cavity abnormality, such as a uterine congenital malformation, untreated uterine septum (except shallow uterine septum), adenomyosis, submucous myoma, or moderate to severe intrauterine adhesions. * 5. Women with uncontrolled diabetes mellitus, thyroid disease and hypertension. * 6. Women who are indicated and planned to undergo preimplantation genetic test (PGT).
Where this trial is running
Changsha, Hunan
- Reproductive & Genetic Hospital of CITIC-Xiangya — Changsha, Hunan, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: PCOS