FET
Conditions
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).
Interventions
OTHERLow 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.
Sponsors
Nanjing University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Incidence of thrombosis | 12 weeks after embryo transfer | Thrombosis incidence refers to the proportion of patients with deep venous thrombosis in the total 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactJun Xing
Backup ContactChenyang Huang
Outcome results
None listed