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

PCOS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05227391
• Other study ID #: P2022001
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Reproductive & Genetic Hospital of CITIC-Xiangya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1078
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

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).

Related Conditions & MeSH terms

• PCOS

Intervention

Procedure:
• Oral Letrozole
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
Oral estradiol valerate at a dose of 3mg twice daily will be started on days 3-5 of the menstrual cycle.

Locations

Country	Name	City	State
China	Reproductive & Genetic Hospital of CITIC-Xiangya	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive & Genetic Hospital of CITIC-Xiangya

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	11 months
Secondary	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.	2 months
Secondary	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.	1.5 months
Secondary	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.	9 months
Secondary	Cycle cancellation rate	Number of women who initiated endometrial preparation without embryos transfer / number of women randomized to the specific group.	1 month
Secondary	Birth weight	Weight of newborns at delivery.	11 months
Secondary	Incidence of obstetric and perinatal complications	Number of pregnancies with complications / number of clinical pregnancies.	11 months
Secondary	Incidence of neonatal complications	Number of live births with neonatal complications / number of live births.	11 months
Secondary	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.	2 months