Live Birth After Letrozole-stimulated Cycles Versus Hormone Replacement Treatment Cycles for the First Frozen Embryo Transfer in Women With PCOS

Reproductive & Genetic Hospital of CITIC-Xiangya

Status: Enrolling

Conditions: PCOS

Treatments: Procedure: Oral estradiol valerate; Procedure: Oral Letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT05227391

P2022001

Details and patient eligibility

About

This is a multicenter randomized controlled trial comparing the efficacy and safety of two endometrial preparation protocols for the first frozen embryo transfer cycle in PCOS with whole embryo freezing. Subjects will be randomized to letrozole-stimulated group or hormone replacement treatment group in their first frozen embryo transfer cycle, and their pregnancy and perinatal outcomes during this cycle will be followed up and analysis.

Enrollment: 1,078 estimated patients

Sex: Female

Ages: 20 to 38 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,078 participants in 2 patient groups

Letrozole-stimulated group

Experimental group

Treatment:

Procedure: Oral Letrozole

Hormone replacement treatment group

Active Comparator group

Treatment:

Procedure: Oral estradiol valerate