NCT06644794 Progesterone-modified Natural Cycle for FET
| NCT ID | NCT06644794 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Shandong University of Traditional Chinese Medicine |
| Condition | Infertility, Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 336 participants |
| Start Date | 2025-03-05 |
| Primary Completion | 2027-09-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 336 participants in total. It began in 2025-03-05 with a primary completion date of 2027-09-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Zhen-Gao Sun, MD
PRINCIPAL INVESTIGATOR
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Frequently Asked Questions
Who can join the NCT06644794 clinical trial?
This trial is open to female participants only, aged 21 Years or older, up to 44 Years, studying Infertility, Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06644794 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 336 participants.
Is NCT06644794 currently recruiting?
Yes, NCT06644794 is actively recruiting participants. Contact the research team at caoxianlingling@163.com for enrollment information.
Where is the NCT06644794 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06644794 clinical trial?
NCT06644794 is sponsored by Shandong University of Traditional Chinese Medicine. The principal investigator is Zhen-Gao Sun, MD at Affiliated Hospital of Shandong University of Traditional Chinese Medicine. The trial plans to enroll 336 participants.