Clinical Pregnancy Clinical Trial
— FETOfficial title:
Comparison of Immediate With Delayed Natural Cycle Frozen Embryo Transfers From Freeze-all-IVF Cycles: a Randomized Control Trial of First Frozen Embryo Transfers
Introduction: Based on recent studies the suggestion is that natural cycle frozen embryo transfers (NC FET) should preferably be used, with evidence suggesting that artificial cycle FET (AC FET) is subject to increased risks of adverse obstetric and perinatal outcomes and possibly lower live birth rates. There, however, is limited evidence on the most efficient and effective timing of NC FET following oocyte retrieval. Objective: In this non-inferiority randomised controlled trial, the effect on reproductive outcomes of NC FET performed immediately following the oocyte retrieval cycle (i.e., after one menstruation) will be investigated. Materials and Methods: At a single IVF centre, patients will be recruited from infertile patients presenting for freeze-all-IVF treatments. Patients aged 18 to 30 years will be enrolled, if they had ≤2 previous embryo transfers and had ≥1 blastocyst cryopreserved in their freeze-all cycles. Enrolled patients (N = 800) will be randomised (1:1) to either the immediate group (i.e., FET performed in the menstrual cycle immediately following the oocyte retrieval cycle) or the delayed group (i.e., FET performed in the menstrual cycle following two menstruations). All FET will be performed in NC. The primary outcome measure will be clinical pregnancy, defined as the visual confirmation by transvaginal ultrasound scan of a gestational sac with normal heartbeat at >5 weeks of gestation. The analyses will be performed according to per-procedure principles. Results: The ovarian, endometrial and time to transfer outcomes of the immediate group will be compared with those of the delayed group. The clinical pregnancy rate of the immediate group will be compared with that of the delayed group.
Status | Recruiting |
Enrollment | 800 |
Est. completion date | March 30, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Patients with female age 18=40 years. - Patients who provide written informed consent to participate in the trial and for the use of their anonymized data in research. - Patients with <2 previous IVF treatments. - Patients with =1 blastocyst cryopreserved. Exclusion Criteria: - Patients with female age >40 years - Patients with female BMI =30 kg/m2. - Female patients with insulin dependent diabetes or non-insulin dependent diabetes mellitus and female patients with gastrointestinal, cardiovascular, pulmonary, liver or kidney disease. - Female patients with any contraindications or allergies to the drugs used in routine freeze-all-IVF. - Patients with untreated intrauterine anomalies and tubal pathology. - Patients undergoing PGT-A (aneuploidy) or PGT-M (monogenic disorders) - Patients with no blastocysts cryopreserved. |
Country | Name | City | State |
---|---|---|---|
Turkey | Antalya IVF | Antalya |
Lead Sponsor | Collaborator |
---|---|
Antalya IVF |
Turkey,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical pregnancy from frozen embryo transfers | Clinical pregnancy rate will be defined as a pregnancy cycle with a normal gestational sac and fetal heartbeat confirmed by ultrasound at >5.5 weeks of gestation. | Transvaginal ultrasound examination will be performed after 5 weeks of gestation (>5.5 weeks) | |
Secondary | Pregnancy from frozen embryo transfers | Pregnancy will be defined as a cycle with an arbitrary serum ßHCG level of >5 mIU/mL, measured 9 days after blastocyst transfer. | Blood serum pregnancy tests will be performed 9 days after blastocyst transfer | |
Secondary | Early pregnancy loss of frozen embryo transfer pregnancies | Early pregnancy loss will be defined as a pregnancy lost before 10 weeks of gestation. | Serial transvaginal ultrasound scans will be performed to 12 weeks of gestation | |
Secondary | Ongoing pregnancy from frozen embryo transfers | Ongoing pregnancy will be defined as a clinical pregnancy developing normally past 12 weeks of gestation. | Transvaginal ultrasound scan will be performed after 12 weeks of gestation |
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