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CompletedNCT04806919PROTECTAUpdated Mar 23, 2026

Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone

A Phase 3 interventional study of Progesteron TID in IVF, Embryo Loss and Luteal Phase Defect, sponsored by University Hospital, Ghent. Completed at 2 sites in Belgium. Open to female participants aged 18 Years to 43 Years. Per ClinicalTrials.gov, last updated 2026-03-23.

Sponsored by University Hospital, Ghent · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
87
Allocation
Randomized
Ages
18 Years to 43 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • IVF
  • Embryo Loss
  • Luteal Phase Defect
03

In context

Lead sponsor

University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 43 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
87 participants (actual)

Study arms

  • 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

Interventions

  • DrugProgesteron TID

    increasing the dose

06

What researchers measure

Primary outcomes

  1. Ongoing pregnancy rate

    visualization of an embryo with a heart beat

    Time frame: 7 gestational weeks (+ or - 1 week)

Secondary outcomes

  1. Endometrial impaction: Corelation between the change in endometrial thickness on day of embryo transfer and ongoing pregnancy rate

    Time frame: 7 gestational weeks (+ or - 1 week)

Other outcomes

  1. Questionnaire on patient comfort and side effects

    Time frame: On the day of embryo transfer (day 5)

  2. Questionnaire on patient comfort and side effects

    Time frame: On the day of the initial pregnancy test (day 16 (± 2 days))

07

Study locations

2 sites
  • UZ Ghent
    Ghent, 9000, Belgium
  • AZ Delta
    Roeselare, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04806919
Lead sponsor
University Hospital, Ghent
Responsible party
Sponsor
First posted
Mar 19, 2021
Start date
Apr 2, 2021
Primary completion
Feb 28, 2025
Completion
Mar 31, 2025
Last update
Mar 23, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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