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

A Randomized Controlled Trial on Reducing Oestrogen Dosage to Improve the Clinical Outcome of Frozen-thawed Embryo Transfer

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.

Study Overview

• Status: Recruiting
• Conditions: FET
• Intervention / Treatment: Other: Low 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 Type: Interventional
• Enrollment (Anticipated): 660
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun Xing; Phone Number: +862583107188; Email: xing.jun@msn.com
• Study Contact Backup: Name: Chenyang Huang; Phone Number: +862583107188; Email: dianshui19901562@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
      • Contact: Jun Xing; Phone Number: +86 25 8310 7188; Email: xing.jun@msn.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low oestrogen; The patients take orally estradiol tablets 2 mg (Femoston) q.d. during the HRT-FET cycles	Other: Low oestrogen dosage; From the second day of the menstrual cycle, femoston (estradiol tablets) were orally taken 2 mg q.d.. The endometrial thickness and serum oestrogen and progesterone levels were monitored on the 12th to 14th days of the menstrual cycle.
No Intervention: Regular oestrogen; The patients take orally estradiol tablets 2 mg (Femoston) t.i.d. during the HRT-FET cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy rate	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.	45 days after embryo transfer

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nanjing University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens
• Other Study ID Numbers: SZ-HRT-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No