An interventional study of Oral Letrozole and Oral estradiol valerate in PCOS, sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya. Recruiting at 1 site in China. Open to female participants aged 20 Years to 38 Years. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Procedure: Oral Letrozole
Procedure: Oral estradiol valerate
Oral Letrozole at a dose of 2.5mg daily will be started on days 3-5 of the menstrual cycle and will be continued for 5 days.
Oral estradiol valerate at a dose of 3mg twice daily will be started on days 3-5 of the menstrual cycle.
Live birth rate
Number of women with live birth/ number of women randomized to the specific group. Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation.
Time frame: 11 months
Clinical pregnancy rate
Number of women with clinical pregnancy /number of women randomized to the specific group. Clinical pregnancy was defined as the presence of at least one gestational sac in the uterine cavity on ultrasound at about 28 days after embryo transfer.
Time frame: 2 months
Biochemical pregnancy rate
Number of women with biochemical pregnancy /number of women randomized to the specific group. Biochemical pregnancy was defined as a human chorionic gonadotropin level of more than 10 milli-International unit (mIU) per milliliter (ml) as measured at about 14 days after embryo transfer.
Time frame: 1.5 months
Miscarriage rate
Number of women with miscarrage / number of women with clinical pregnancy. Miscarriage refers to a complete spontaneous abortion or a nonviable pregnancy before 28 weeks of gestation.
Time frame: 9 months
Cycle cancellation rate
Number of women who initiated endometrial preparation without embryos transfer / number of women randomized to the specific group.
Time frame: 1 month
Birth weight
Weight of newborns at delivery.
Time frame: 11 months
Incidence of obstetric and perinatal complications
Number of pregnancies with complications / number of clinical pregnancies.
Time frame: 11 months
Incidence of neonatal complications
Number of live births with neonatal complications / number of live births.
Time frame: 11 months
Ectopic pregnancy rate
Number of women with ectopic pregnancy /number of women randomized to the specific group. Ectopic pregnancy will be defined as implantation outside the uterine cavity, as confirmed by sonography or laparoscopy.
Time frame: 2 months
Plan to share: Yes — All the individual participant data collected during the trial will be shared after deidentification upon request. Study protocol, Statistical analysis plan, informed consent forms, and clinical study report will be available upon request. Data will be available from 3 months following first publication and ending 5 years after the study has been concluded. Individual participant data will be shared with researches who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Reproductive & Genetic Hospital of CITIC-Xiangya