Natural Cycle vs Programmed Cycle Frozen Embryo Transfer

Indira IVF Hospital Pvt Ltd

Status: Terminated

Conditions: Preeclampsia and Eclampsia; Infertility; Frozen Embryo Transfer

Treatments: Procedure: Artificial Cycle; Procedure: Natural Cycle

Study type: Interventional

Funder types: Other

Identifiers

NCT05716139

IIHPL-UDR/RCT/013_2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 patients

Sex: Female

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

172 participants in 2 patient groups

Natural Cycle

Active Comparator group

Description:

In this,hCG trigger and Luteal Phase Support is monitored for the natural frozen embryo cycle procedure of IVF.

Treatment:

Procedure: Natural Cycle

Artificial Cycle

Other group

Description:

In this, endometrial preparation and Luteal Phase Support is monitored for the artificial frozen embryo cycle procedure of IVF.

Treatment:

Procedure: Artificial Cycle