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

Nanjing University

Status: Enrolling

Conditions: FET

Treatments: Other: Low oestrogen dosage

Study type: Interventional

Funder types: Other

Identifiers

NCT05545592

SZ-HRT-2022

Details and patient eligibility

About

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.

Full 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).

Enrollment: 660 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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660 participants in 2 patient groups

Low oestrogen

Experimental group

Description:

The patients take orally estradiol tablets 2 mg (Femoston) q.d. during the HRT-FET cycles

Treatment:

Other: Low oestrogen dosage

Regular oestrogen

No Intervention group

Description:

The patients take orally estradiol tablets 2 mg (Femoston) t.i.d. during the HRT-FET cycles