Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone (PROTECTA)

Randomized Controlled Trial Comparing Micronized Progesterone (Amelgen ®) 400 mg BID Versus 400 mg TID for Luteal Support in Artificial Vitrified/Warmed Single Blastocyst Transfer Cycles With Low Progesterone on Day of Embryo Transfer

The study aims to evaluate the effect of an increased dose of vaginal progesterone supplementation on the incidence of ongoing pregnancy for patients with a suboptimal serum progesterone level (defined as < 10 mcg/l) on the day of blastocyst transfer.

Study Overview

• Status: Recruiting
• Conditions: Luteal Phase Defect; IVF; Embryo Loss
• Intervention / Treatment: Drug: Progesteron TID

• Study Type: Interventional
• Enrollment (Estimated): 242
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • UZ Ghent
    • Contact: Dominic Stoop; Phone Number: 0032 9 332 30 48; Email: dominic.stoop@uzgent.be
  • Roeselare, Belgium
    • Not yet recruiting
    • AZ Delta
    • Contact: Annelies De Knijf, MD; Phone Number: 0032 51 23 63 82; Email: fertiliteit@azdelta.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 41 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Informed consent form (ICF) dated and signed
• Age ≥ 18 and < 43 years old
• Body Mass Index (BMI) ≥ 18.5 kg/m2 and < 35 kg/m2
• Less than 4 previous Assisted Reproductive Technologies (ART) cycles
• Current pregnancy wish
• Patients undergoing a single vitrified/warmed single transfer in an artificial prepared endometrium cycle (IVF or ICSI)

Exclusion Criteria:

• Simultaneous participation in another clinical study
• Previous participation in this study
• Known reasons for impaired implantation (specifically: presence of a hydrosalpinx; presence of a type I, II or III fibroid; Asherman's syndrome; uterine malformations, intrauterine adhesions, ≥ grade 3 endometriosis according to the ASRM classification, endometrial tuberculosis)
• Repeated miscarriages (> 2 miscarriages)
• Untreated and uncontrolled thyroid dysfunction
• Tumors of the ovary, breast, uterus, pituitary or hypothalamus
• Abnormal vaginal bleeding without a known/diagnosed cause
• Ovarian cysts or enlarged ovaries
• Fibroid tumors of the uterus incompatible with pregnancy
• Malformations of the reproductive organs incompatible with pregnancy
• Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin)
• Risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia
• Active smoking
• Ongoing pregnancy
• Use of carbamazepine, rifampicin or phenytoin
• Those unable to comprehend the investigational nature of the proposed study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group: Amelgen ® 400 mg BID; Continue daily dose progesteron
Experimental: Intervention group: Amelgen ® 400 mg TID; Increase daily progesteron dose	Drug: Progesteron TID; increasing the dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ongoing pregnancy rate	visualization of an embryo with a heart beat	7 gestational weeks (+ or - 1 week)

Secondary Outcome Measures

Outcome Measure	Time Frame
Endometrial impaction: Corelation between the change in endometrial thickness on day of embryo transfer and ongoing pregnancy rate	7 gestational weeks (+ or - 1 week)

Other Outcome Measures

Outcome Measure	Time Frame
Questionnaire on patient comfort and side effects	On the day of embryo transfer (day 5)
Questionnaire on patient comfort and side effects	On the day of the initial pregnancy test (day 16 (± 2 days))

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2021
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Abortion, Spontaneous; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Embryo Loss; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: 2020-004112-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No