Preeclampsia Following Natural vs. Artificial Cycle Frozen Embryo Transfer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 172
- Locations
- 2
- Primary Endpoint
- proportion of preeclampsia
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Parallel group open labelled masking
Eligibility Criteria
- Ages
- 21 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
proportion of preeclampsia
Time Frame: after the 20th week of gestation up to six weeks postpartum
The primary efficacy endpoint is the proportion of preeclampsia in women assigned to a natural cycle protocol compared to the proportion of preeclampsia in women assigned to an artificial cycle protocol.
Secondary Outcomes
- HELLP Syndrome(After 20 weeks of GA till 6 weeks postpartum)
- Fetal growth restriction(20-40 weeks of gestation)
- Maternal hypertension(After 20 weeks of GA till 6 weeks postpartum)
- Maternal mortality(from start of pregnancy to 42 weeks of pregnancy)
- Fetal death(20 weeks of GA before delivery)
- Eclampsia(After 20 weeks of GA till 6 weeks postpartum)
- Fetal birthweight(within 30 minutes of birth)
- Premature detachment of normally inserted placenta(12 weeks of GA till labor)
- Biochemical Pregnancy Rate(6 weeks after Embryo Transfer)
- Implantation Rate(4 weeks +2 weeks after ET)
- Clinical Pregnancy Rate(4 weeks +2 weeks after ET)
- Ongoing Pregnancy Rate(12 weeks after embryo Transfer)
- Live Birth Rate(28 weeks(+12 weeks) after embryo transfer)
- Miscarriage Rate(Within 20 weeks of gestation)
- Preterm birth(< 37 weeks)
- Extreme preterm birth(20-28 weeks)
- Frequency of adverse events(through study completion, an average of 1 year)