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Completed

NCT Number: NCT04806919

Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone

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.

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Key information

Conditions

IVF Abortion, Spontaneous Death Embryo Loss Female Urogenital Diseases and Pregnancy Complications Luteal Phase Defect Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

UZ Ghent, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progesteron TID

Drug

increasing the dose

Primary outcomes

  1. Ongoing pregnancy rate

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

    visualization of an embryo with a heart beat

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))

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Acronym: PROTECTA

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2021
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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