Reducing oestrogen dosage to improve outcomes in embryo transfer

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

This study is testing if using a lower dose of estrogen during hormone therapy for frozen embryo transfers can help reduce complications for mothers and babies while still achieving similar pregnancy success rates.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 660 (estimated)
• Ages: 20 Years to 40 Years
• Sex: Female
• Sponsor: Nanjing University (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05545592 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of reduced oestrogen dosage on maternal and fetal complications during hormone replacement therapy for frozen-thawed embryo transfer (HRT-FET). It is a single-center, randomized, controlled prospective study where participants are divided into two groups: one receiving a lower oestrogen dosage and the other receiving the standard dosage. The aim is to maintain similar clinical pregnancy outcomes while potentially reducing complications associated with higher oestrogen levels.

Who should consider this trial

Good fit: Ideal candidates are females aged 20 to 40 years with a BMI between 18.5 and 28 kg/m2 who are undergoing frozen-thawed embryo transfer.

Not a fit: Patients with chromosomal abnormalities or significant uterine conditions that affect embryo implantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to safer embryo transfer procedures with fewer complications for mothers and babies.

How similar studies have performed: While this specific approach is novel, similar studies have explored the effects of hormone dosage on pregnancy outcomes, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Nanjing, Jiangsu

• Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Jun Xing

Conditions FET