Natural Cycle vs Programmed Cycle Frozen Embryo Transfer

Preeclampsia Following Natural vs. Artificial Cycle Frozen Embryo Transfer

The goal of this[ type of study: randomized controlled trial]is to compare Preeclampsia following Natural vs. Artificial Cycle in patients undergoing frozen embryo transfer.

The main question[s] it aims to answer is

• Does NC-FET decreases the incidence of preeclampsia in patients undergoing frozen embryo transfer as compared to AC-FET ?

The main objective is to compare the proportion of preeclampsia in women with a viable pregnancy with natural cycle protocol to artificial cycle protocol when practicing frozen embryo transfer. Participants recruited will be divided into two ARM(1513 per arm). ARM 1 will undergo the Natural Cycle procedure of Embryo transfer, and ARM 2 will undergo the Artificial Cycle procedure of Embryo transfer. The primary outcome will be the proportion of preeclampsia. The duration of the study is around 2 year.

The Research question(PICO) addressed is Does NC-FET decreases the incidence of preeclampsia in patients undergoing frozen embryo transfer as compared to AC-FET . The hypothesis taken is NC-FET will decrease the incidence of preeclampsia compared to AC-FET. The sample size is taken as 3026 (1513 per arm). The Primary Objective is to compare the proportion of preeclampsia in women with a viable pregnancy with natural cycle protocol to artificial cycle protocol when practicing frozen embryo transfer. The study outcome of the proportion of preeclampsia after 20 weeks of gestation or 6 weeks post-delivery. There are two arms-Arm 1 Active Comparator: Natural Cycle and Arm 2 control: Artificial Cycle FET. The Randomization is done through Random Allocation as per computer generated sequence. The Blinding/masking is done Open labeled. The Study Duration is from Feb 2023 to Jan 2025. Participation Duration is 10 months.

Inclusion Criteria:

• Endometrial preparation with Hormone replacement therapy/ Natural cycle.
• Age 21-45 years following an autologous IVF cycle (with or without preimplantation genetic testing for aneuploidy)
• BMI > 18 and < 30 kg/m2
• Endometrial thickness ≥ 7 mm after estrogen therapy or on the day of ovulation
• Blastocyst embryo transfer

Exclusion Criteria:

• Uterine diseases (e.g. submucosal fibroids, polyps, previously diagnosed Müllerian abnormalities)
• Hydrosalpinx untreated.
• Recurrent pregnancy loss (≥ 3 previous miscarriages)
• Recurrent implantation failure (≥ 3 previously failed embryo transfers of good-quality blastocysts)
• Allergy to study medication
• Pregnancy or lactation at recruitment
• Contraindications for hormonal treatment