Reduced Oestrogen Dosage to Improve the Outcome of Frozen-thawed Embryo Transfer

Not Applicable

Recruiting

• Conditions: FET
• Interventions: Other: Low oestrogen dosage

• Registration Number: NCT05545592
• Lead Sponsor: Nanjing University

Brief Summary

This study is a single-center, randomized, controlled prospective study. Those who will recieve hormone replacement therapy-frozen thawed embryo transfer (HRT-FET) are enrolled in the study. To determine the effect of oestrogen dosage reducion on maternal and fetal complications in HRT-FET cycles while maintaining the similar clinical pregnancy outcome in HRT-FET cycles with regular oestrogen dosage.

Detailed Description

According to the enrollment and exclusion criteria, the patients were enrolled, and the subjects were randomly divided into two groups by computer randomization. Group A was the reduced oestrogen dosage group (test group). Group B was the regular hormone replacement group (control group).

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-15
• Last Update Submitted: 2022-09-15
• Study First Posted: 2022-09-19
• Last Update Posted: 2022-09-19
• Study Start: 2022-10-01
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 660

Inclusion Criteria

1. Female;
2. Aged between 20 and 40 years old;
3. Frozen thawed embryo transfer is proposed, and the type of transferred embryo is blastocyst (the number of transferred embryos is 1);
4. Body mass index (BMI) ≤ 28 kg/m2, ≥ 18.5 kg/m2;
5. The total number of transfer cycles was < 3;
6. Volunteer to participate in the study and sign the informed consent.

Exclusion Criteria

1. Patients with chromosomal abnormalities;
2. Contraindications to hormone replacement therapy;
3. Patients with uterine myoma, severe adenomyosis, endometriosis, congenital uterine malformation, endometrial tuberculosis, intrauterine adhesions and other diseases that significantly affect embryo implantation;
4. Participating in other clinical studies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low oestrogen	Low oestrogen dosage	The patients take orally estradiol tablets 2 mg (Femoston) q.d. during the HRT-FET cycles

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	45 days after embryo transfer	Clinical pregnancy is defined as the presence of gestational sac observed by ultrasound. The proportion of clinical pregnancy cycles to total FET cycles is the clinical pregnancy rate.

Secondary Outcome Measures

Name	Time	Method
Early pregnancy loss rate	12 weeks after embryo transfer	The early pregnancy loss rate refers to the proportion of patients with pregnancy loss before 12 weeks of gestation in the total clinical pregnancy patients.
Embryo implantation rate	45 days after embryo transfer	The proportion of the number of implanted embryos to the total number of transferred embryos is the embryo implantation rate.
Incidence of thrombosis	12 weeks after embryo transfer	Thrombosis incidence refers to the proportion of patients with deep venous thrombosis in the total patients.
Incidence rate of gestational hypertension	45 weeks after embryo transfer	The incidence rate of gestational hypertension refers to the proportion of patients with gestational hypertension in the total pregnant patients.
Premature birth rate	41 weeks after embryo transfer	Preterm birth rate refers to the proportion of patients with preterm birth in all pregnancies.
Proportion of low birth weight infants	41 weeks after embryo transfer	The proportion of low birth weight infants refers to the proportion of low birth weight infants in all newborns.

Trial Locations

Locations (1)

Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China