Infertility, Female
Conditions
Keywords
Progesterone-modified natural cycle, Hormone replacement therapy, Frozen-thawed embryo transfer
Brief summary
Hormone replacement therapy (HRT) cycles, despite the ease of synchronizing embryo thawing and embryo transfer timing, increase the risk of pregnancies and obstetric complications compared to natural cycles (NC). By ensuring the presence of the corpus luteum while reducing the number of monitoring sessions, the progesterone modified natural cycle (P4mNC) offers more convenience for the patient than the normal NC. This study is designed to compare the effects of P4mNC and HRT cycles on FET outcomes.
Interventions
DRUGProgesterone-modified natural cycle preparation for frozen embryo transfer
A novel endometrial preparation protocol that optimizes the natural cycle, whereby as long as the thickness of the endometrium is suitable for embryo transfer, vaginal progesterone can be used to transform the endometrium before ovulation and subsequently FET.
DRUGHormone replacement therapy cycle preparation for frozen embryo transfer
A traditional endometrial preparation protocol is used for FET, which involves using fixed or flexible exogenous estradiol for artificial cycles. This protocol typically involves starting exogenous estradiol on day 3 or 4 of the cycle, continuing for 7-10 days, and then discontinuing. Upon determining that the endometrial thickness meets the standard, progesterone conversion of the endometrium can be performed.
Sponsors
Shandong University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 44 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 21 to 44 years undergoing FBT * Body mass index (BMI) 18-35 kg/m2 * Having regular ovulatory cycles
Exclusion criteria
* Untreated uterine adhesions * Medical contraindications to estrogen and progesterone therapy * Illnesses contraindicating assisted reproductive technology or pregnancy * History of recurrent implantation failures (\> 2 embryo transfer failures)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live birth | Within 1 year after randomization | A live birth is defined as the delivery of any surviving newborn at 28 weeks or more of gestation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical pregnancy | Two weeks after embryo transfer | Serum level of ß-hCG \> 50 mIU/mL |
| Clinical pregnancy | Five weeks after embryo transfer | Fetal heartbeat observed by vaginal ultrasound |
| Ongoing pregnancy | Ten weeks after embryo transfer | The presence of a gestational sac and fetal heartbeat after 12 weeks of gestation |
| Miscarriage | Within 28 weeks of pregnancy | A condition in which the embryo or fetus does not survive and is not spontaneously absorbed or expelled from the uterus |
Countries
China
Contacts
CONTACTXian-Ling Cao, MD
PRINCIPAL_INVESTIGATORZhen-Gao Sun, MD
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Outcome results
None listed