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

Not Applicable

Recruiting

• Conditions: PCOS
• Interventions: Procedure: Oral estradiol valerate; Procedure: Oral Letrozole

• Registration Number: NCT05227391
• Lead Sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-26
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-02-07
• Study Start: 2022-03-16
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1078

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hormone replacement treatment group	Oral estradiol valerate	-
Letrozole-stimulated group	Oral Letrozole	-

Primary Outcome Measures

Name	Time	Method
Live birth rate	11 months	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.

Secondary Outcome Measures

Name	Time	Method
Miscarriage rate	9 months	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.
Cycle cancellation rate	1 month	Number of women who initiated endometrial preparation without embryos transfer / number of women randomized to the specific group.
Incidence of obstetric and perinatal complications	11 months	Number of pregnancies with complications / number of clinical pregnancies.
Incidence of neonatal complications	11 months	Number of live births with neonatal complications / number of live births.
Ectopic pregnancy rate	2 months	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.
Clinical pregnancy rate	2 months	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.
Biochemical pregnancy rate	1.5 months	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.
Birth weight	11 months	Weight of newborns at delivery.

Trial Locations

Locations (1)

Reproductive & Genetic Hospital of CITIC-Xiangya; 🇨🇳 Changsha, Hunan, China