Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone (PROTECTA)
Primary Purpose
IVF, Embryo Loss, Luteal Phase Defect
Status
Recruiting
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Progesteron TID
Sponsored by
About this trial
This is an interventional treatment trial for IVF
Eligibility Criteria
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
Sites / Locations
- UZ GhentRecruiting
- AZ Delta
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group: Amelgen ® 400 mg BID
Intervention group: Amelgen ® 400 mg TID
Arm Description
Continue daily dose progesteron
Increase daily progesteron dose
Outcomes
Primary Outcome Measures
Ongoing pregnancy rate
visualization of an embryo with a heart beat
Secondary Outcome Measures
Endometrial impaction: Corelation between the change in endometrial thickness on day of embryo transfer and ongoing pregnancy rate
Full Information
NCT ID
NCT04806919
First Posted
January 18, 2021
Last Updated
June 27, 2023
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT04806919
Brief Title
Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone
Acronym
PROTECTA
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IVF, Embryo Loss, Luteal Phase Defect
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group: Amelgen ® 400 mg BID
Arm Type
No Intervention
Arm Description
Continue daily dose progesteron
Arm Title
Intervention group: Amelgen ® 400 mg TID
Arm Type
Experimental
Arm Description
Increase daily progesteron dose
Intervention Type
Drug
Intervention Name(s)
Progesteron TID
Intervention Description
increasing the dose
Primary Outcome Measure Information:
Title
Ongoing pregnancy rate
Description
visualization of an embryo with a heart beat
Time Frame
7 gestational weeks (+ or - 1 week)
Secondary Outcome Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
Questionnaire on patient comfort and side effects
Time Frame
On the day of embryo transfer (day 5)
Title
Questionnaire on patient comfort and side effects
Time Frame
On the day of the initial pregnancy test (day 16 (± 2 days))
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UZ Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominic Stoop
Phone
0032 9 332 30 48
Email
dominic.stoop@uzgent.be
Facility Name
AZ Delta
City
Roeselare
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annelies De Knijf, MD
Phone
0032 51 23 63 82
Email
fertiliteit@azdelta.be
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone
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