Natural Cycle vs Programmed Cycle Frozen Embryo Transfer

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05716139
Study type	Interventional
Source	Indira IVF Hospital Pvt Ltd
Contact	Nikolaos P. Polyzos, MD
Phone	+34 932274896
Email	nikpol@dexeus.com
Status	Recruiting
Phase	N/A
Start date	July 15, 2023
Completion date	January 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03607409` - Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment
Recruiting	`NCT02312076` - GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles	Phase 4
Terminated	`NCT02161861` - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study	N/A
Completed	`NCT03287479` - Comparison of a Semi-automated Closed Vitrification System (Gavi®) With a Manual Open Vitrification Sytem (Cryotop®)	N/A
Terminated	`NCT03522350` - Randomized Trial Comparing EmbryoScope With EmbryoScope+.	N/A
Completed	`NCT04496284` - Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen	N/A
Completed	`NCT03623659` - pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts	N/A
Completed	`NCT03895099` - New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors	Phase 3
Active, not recruiting	`NCT04142112` - Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation	N/A
Completed	`NCT03152643` - Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer	N/A
Recruiting	`NCT03683771` - Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome
Recruiting	`NCT03161119` - Comparing Two Different Embryo Transfer Catheters	N/A
Completed	`NCT04108039` - Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.	N/A
Completed	`NCT03678610` - Handling Medium for ICSI With Ionomycin and Latrunculin A	N/A
Completed	`NCT03678818` - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA)	N/A
Completed	`NCT03677492` - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)	N/A
Completed	`NCT03678584` - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)	N/A
Completed	`NCT03678597` - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)	N/A
Completed	`NCT03678558` - Oocyte Vitrification Aided With Cytochalasin B	N/A
Completed	`NCT03678571` - Oocyte Vitrification Aided With Latrunculin A	N/A