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

Sponsor
University Hospital, Ghent (Other)
Overall Status
Recruiting
CT.gov ID
NCT04806919
Collaborator
(none)
242
Enrollment
2
Locations
2
Arms
33
Anticipated Duration (Months)
121
Patients Per Site
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Progesteron TID
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
242 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Apr 2, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Ongoing pregnancy rate [7 gestational weeks (+ or - 1 week)]

    visualization of an embryo with a heart beat

Secondary Outcome Measures

  1. 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

  1. Questionnaire on patient comfort and side effects [On the day of embryo transfer (day 5)]

  2. Questionnaire on patient comfort and side effects [On the day of the initial pregnancy test (day 16 (± 2 days))]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 43 Years
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Ghent Ghent Belgium 9000
2 AZ Delta Roeselare Belgium

Sponsors and Collaborators

  • University Hospital, Ghent

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT04806919
Other Study ID Numbers:
  • 2020-004112-10
First Posted:
Mar 19, 2021
Last Update Posted:
Jul 7, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Embryo Loss
Progesterone

Study Results

No Results Posted as of Jul 7, 2022