A Randomized Controlled Trial on Reducing Oestrogen Dosage to Improve the Clinical Outcome of Frozen-thawed Embryo Transfer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- FET
- Sponsor
- Nanjing University
- Enrollment
- 660
- Locations
- 1
- Primary Endpoint
- Clinical pregnancy rate
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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).
Investigators
Li-jun Ding
principal investigator
Nanjing University
Eligibility Criteria
Inclusion Criteria
- •Aged between 20 and 40 years old;
- •Frozen thawed embryo transfer is proposed, and the type of transferred embryo is blastocyst (the number of transferred embryos is 1);
- •Body mass index (BMI) ≤ 28 kg/m2, ≥ 18.5 kg/m2;
- •The total number of transfer cycles was \< 3;
- •Volunteer to participate in the study and sign the informed consent.
Exclusion Criteria
- •Patients with chromosomal abnormalities;
- •Contraindications to hormone replacement therapy;
- •Patients with uterine myoma, severe adenomyosis, endometriosis, congenital uterine malformation, endometrial tuberculosis, intrauterine adhesions and other diseases that significantly affect embryo implantation;
- •Participating in other clinical studies.
Outcomes
Primary Outcomes
Clinical pregnancy rate
Time Frame: 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 Outcomes
- Early pregnancy loss rate(12 weeks after embryo transfer)
- Embryo implantation rate(45 days after embryo transfer)
- Incidence of thrombosis(12 weeks after embryo transfer)
- Incidence rate of gestational hypertension(45 weeks after embryo transfer)
- Premature birth rate(41 weeks after embryo transfer)
- Proportion of low birth weight infants(41 weeks after embryo transfer)