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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    1078
  • sponsor
    Reproductive & Genetic Hospital of CITIC-Xiangya
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Updated on 2 May 2022
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estradiol
letrozole
ovarian stimulation

Summary

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.

Details
Condition PCOS
Treatment Oral Letrozole, Oral estradiol valerate
Clinical Study IdentifierNCT05227391
SponsorReproductive & Genetic Hospital of CITIC-Xiangya
Last Modified on2 May 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

\. women diagnosed with PCOS according to modified Rotterdam criteria
\. Women who are participating in their first cycle of IVF or ICSI
\. Women whose IVF/ICSI ovarian stimulation protocol was either GnRH antagonist protocol or long agonist protocol
\. Women with whole embryos freezing
\. Women aged 20 to 38 years old
\. Women BMI 18 kg/m2 to 30 kg/m2
\. 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

\. Women who has a history of recurrent spontaneous abortion
\. Women with unilateral/bilateral oophorectomy
\. Women with untreated Hydrosalpinx
\. 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
\. Women with uncontrolled diabetes mellitus, thyroid disease and hypertension
\. Women who are indicated and planned to undergo preimplantation genetic test (PGT)
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