Clinical Trials Logo
  1. Home
  2. Infertility
  3. NCT04725864

Progesterone as Luteal Support in Frozen IVF Natural Cycles — ProFET  

Infertility Clinical Trial

Official title:
Vaginal Progesterone as Luteal Support for Improvement of Live Birth in Frozen/Thawed In-vitro Fertilization Natural Cycles; a Multicenter, Open, Randomized Trial

Clinical Trial Summary

The ProFET study aims to investigate if luteal phase support by vaginal progesterone, is superior to no luteal phase support, in terms of live birth rate per woman after a frozen embryo transfer (FET), in a natural cycle (NC) after in-vitro fertilization (IVF), and if 7 weeks of treatment is superior to 3 weeks duration.

Clinical Trial Description

Vaginal progesterone supplementation is routine treatment after IVF with fresh embryo transfer, but it is uncertain whether vaginal progesterone after frozen embryo transfer in natural cycles is efficacious in terms of increasing the chance of a live birth. The ProFET study is a multicenter, open randomized, controlled trial planning to include 1800 women, intended to undergo a FET in a natural cycle. Primary objectives are to investigate if luteal phase support by vaginal progesterone, is superior to no luteal phase support, in terms of live birth rate per woman after a frozen embryo transfer, in a natural cycle and if 7 weeks of treatment is superior to 3 weeks duration. Secondary objectives are to compare groups regarding pregnancy outcomes including biochemical pregnancy, clinical, ongoing and term pregnancy rates, as well as rates of miscarriage, termination of pregnancy, and ectopic pregnancy. Secondary objectives are also perinatal and obstetrics outcomes, self-reported side effects, adverse events and cost effectiveness. The investigators will also analyze the effect of S-Progesterone level before FET on the chance of achieving live birth and secondary pregnancy outcomes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04725864
Study type Interventional
Source Vastra Gotaland Region
Contact Åsa Magnusson, MD, PhD
Phone +46 70-265 55 85
Email asa.magnusson@vgregion.se
Status Recruiting
Phase Phase 4
Start date May 1, 2021
Completion date December 31, 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 NCT03678558 - Oocyte Vitrification Aided With Cytochalasin B N/A
Completed NCT03678597 - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB) N/A
Completed NCT03678571 - Oocyte Vitrification Aided With Latrunculin A N/A
Completed NCT03678584 - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA) N/A