Clinical trial NCT05716139: Natural Cycle vs Programmed Cycle Frozen Embryo Transfer
Official title: Preeclampsia Following Natural vs. Artificial Cycle Frozen Embryo Transfer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Frozen Embryo Transfer
Preeclampsia and Eclampsia
Keywords: Reproduction
In vitro fertilization
Natural Frozen Embryo Transfer
Artificial Frozen Embryo Transfer
Preeclampsia
Lead sponsor: Indira IVF Hospital Pvt Ltd
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 172
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open labelled parallel group randomized Controlled Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: proportion of preeclampsia
timeFrame: after the 20th week of gestation up to six weeks postpartum
Secondary outcomes:
measure: Biochemical Pregnancy Rate
timeFrame: 6 weeks after Embryo Transfer
measure: Implantation Rate
timeFrame: 4 weeks +2 weeks after ET
measure: Clinical Pregnancy Rate
timeFrame: 4 weeks +2 weeks after ET
measure: Ongoing Pregnancy Rate
timeFrame: 12 weeks after embryo Transfer
measure: Live Birth Rate
timeFrame: 28 weeks(+12 weeks) after embryo transfer
measure: Miscarriage Rate
timeFrame: Within 20 weeks of gestation
measure: Preterm birth
timeFrame: < 37 weeks
measure: Extreme preterm birth
timeFrame: 20-28 weeks
measure: Fetal growth restriction
timeFrame: 20-40 weeks of gestation
measure: Fetal birthweight
timeFrame: within 30 minutes of birth
measure: Premature detachment of normally inserted placenta
timeFrame: 12 weeks of GA till labor
measure: Maternal hypertension
timeFrame: After 20 weeks of GA till 6 weeks postpartum
measure: Eclampsia
timeFrame: After 20 weeks of GA till 6 weeks postpartum
measure: HELLP Syndrome
timeFrame: After 20 weeks of GA till 6 weeks postpartum
measure: Maternal mortality
timeFrame: from start of pregnancy to 42 weeks of pregnancy
measure: Fetal death
timeFrame: 20 weeks of GA before delivery
measure: Frequency of adverse events
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Udaipur
country: India
facility: Indira IVF Hospital Private Limited
state: Rajasthan
Study officials:
References:
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