Back to resultsMIcronized PROgesterone in Frozen Embryo Transfer Cycles (MI-PROF)
Primary Purpose
Infertility
Status
Recruiting
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Vaginal progesterone 600mg daily
Vaginal progesterone 800mg daily
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria: Endometrial preparation with hormone replacement therapy Age 18-43 years following an autologous IVF cycle (with or without preimplantation genetic testing for aneuploidy) Age < 50 years following an egg donation cycle BMI > 18 and < 30 kg/m2 blastocyst embryo transfer Willing to participate in the study Able to come to the Center to comply with the procedures of the study: blood tests, appointments and drug dispensation. Exlusion Criteria: • Uterine diseases (e.g. submucosal fibroids, polyps, previously diagnosed Müllerian abnormalities) Hydrosalpinx Recurrent pregnancy loss (≥ 3 previous miscarriages) Recurrent implantation failure (≥ 3 previously failed embryo transfers of good-quality blastocysts) Allergy to study medication Pregnancy or lactation Contraindication for hormonal treatment Personalized initiation of exogenous progesterone according to a previous endometrial receptivity assay test Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfere with the trial assessment).
Sites / Locations
- Hospital Universitario Quiron DexeusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Vaginal progesterone 600mg
Vaginal progesterone 800mg
Arm Description
Vaginal progesterone 600mg daily (200mg tid) will be started and maintained until 10 weeks of pregnancy or either up to menses or up to negative pregnancy test performed 10 days after ET
Vaginal progesterone 800mg daily (400mg bid) will be started and maintained until 10 weeks of pregnancy or either up to menses or up to negative pregnancy test performed 10 days after ET.
Outcomes
Primary Outcome Measures
Ongoing pregnancy rate
A positive heart beat at ultrasound after 11-13 weeks of gestation
Secondary Outcome Measures
Implantation rate
Number of gestational sacs over total embryo transfered
Biochemical pregnancy rate
positive beta-human chorionic gonadotropin (hCG)
Clinical pregnancy rate
A positive heart beat at ultrasound
Miscarriage rate
any spontaneous abortion that occurred after confirmation of clinical pregnancy
Frequency of adverse events
Full Information
NCT ID
NCT05899010
First Posted
June 1, 2023
Last Updated
July 5, 2023
Sponsor
Fundación Santiago Dexeus Font
1. Study Identification
Unique Protocol Identification Number
NCT05899010
Brief Title
MIcronized PROgesterone in Frozen Embryo Transfer Cycles
Acronym
MI-PROF
Official Title
A Phase III Randomized Controlled Trial Comparing the Efficacy, Safety and Tolerability of Two Formulations of Vaginal Micronized Progesterone
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
April 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Santiago Dexeus Font
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This randomized trial was designed as non-inferiority trial aiming to compare ongoing pregnancy rates following LPS with 600 mg/day vs 800 mg/day vaginal VMP. All patients will undergo an artificial cycle frozen embryo transfer (AC-FET) with transdermal estradiol 6mg/day Patients undergoing an artificial cycle FET will start estrogen priming with transdermal estradiol 6mg/day (Estrogel®) on cycle D1-D3. Following 10-12 days of estrogen priming, patients will be randomized to luteal phase support with a standard formulation (200mg tid, Utrogestan®) or a new formulation (400mg bid) VMP. All patients will undergo a serum P measurement on the day before embryo transfer (ET). Patients with P<10 ng/ml will receive a supplement of oral micronized progesterone 300mg, while patients with P≥10ng/ml will maintain the previous luteal phase support (LPS) protocol
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1020 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vaginal progesterone 600mg
Arm Type
Active Comparator
Arm Description
Vaginal progesterone 600mg daily (200mg tid) will be started and maintained until 10 weeks of pregnancy or either up to menses or up to negative pregnancy test performed 10 days after ET
Arm Title
Vaginal progesterone 800mg
Arm Type
Experimental
Arm Description
Vaginal progesterone 800mg daily (400mg bid) will be started and maintained until 10 weeks of pregnancy or either up to menses or up to negative pregnancy test performed 10 days after ET.
Intervention Type
Drug
Intervention Name(s)
Vaginal progesterone 600mg daily
Intervention Description
If endometrial thickness (ETH) ≥7 mm and follicle dominance/ultrasound (US) signs of ovulation P levels are measured: if P ≤1.5 patients start LPS, else cycle is cancelled. If ETH <7mm and no follicle dominance: estradiol dose is increased to 9mg/day and new US is performed up to 4 days after. If persistent thin endometrium after dose increase, cycle is cancelled. 24-48h pre ET, E2 and P are measured. in the morning, pre VMP dose, or at least 6h after last progesterone dose. If progesterone <10ng/ml, additional 300mg daily oral micronized progesterone is administered on the day of the ET and maintained until 10 weeks pregnancy or up to menses or up to negative pregnancy test 10 days after ET. ET will be performed with available blastocysts 6 days after start of LPS. 3-5 days, after ET, a blood test for P measurement will be performed in the morning, before VMP dose, or at least 6h after last progesterone dose. 10 days after ET, the last P test will be done with pregnancy test.
Intervention Type
Drug
Intervention Name(s)
Vaginal progesterone 800mg daily
Intervention Description
If endometrial thickness (ETH) ≥7 mm and follicle dominance/ultrasound (US) signs of ovulation P levels are measured: if P ≤1.5 patients start LPS, else cycle is cancelled. If ETH <7mm and no follicle dominance: estradiol dose is increased to 9mg/day and new US is performed up to 4 days after. If persistent thin endometrium after dose increase, cycle is cancelled. 24-48h pre ET, E2 and P are measured. in the morning, pre VMP dose, or at least 6h after last progesterone dose. If progesterone <10ng/ml, additional 300mg daily oral micronized progesterone is administered on the day of the ET and maintained until 10 weeks pregnancy or up to menses or up to negative pregnancy test 10 days after ET. ET will be performed with available blastocysts 6 days after start of LPS. 3-5 days, after ET, a blood test for P measurement will be performed in the morning, before VMP dose, or at least 6h after last progesterone dose. 10 days after ET, the last P test will be done with pregnancy test.
Primary Outcome Measure Information:
Title
Ongoing pregnancy rate
Description
A positive heart beat at ultrasound after 11-13 weeks of gestation
Time Frame
7-9 weeks after embryo transfer
Secondary Outcome Measure Information:
Title
Implantation rate
Description
Number of gestational sacs over total embryo transfered
Time Frame
3-4 weeks after embryo transfer
Title
Biochemical pregnancy rate
Description
positive beta-human chorionic gonadotropin (hCG)
Time Frame
10 to 12 days after embryo transfer
Title
Clinical pregnancy rate
Description
A positive heart beat at ultrasound
Time Frame
3-4 weeks after embryo transfer
Title
Miscarriage rate
Description
any spontaneous abortion that occurred after confirmation of clinical pregnancy
Time Frame
before completion of 12 weeks of gestation
Title
Frequency of adverse events
Time Frame
Until 15 days after the end of treatment with progesterone
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Endometrial preparation with hormone replacement therapy
Age 18-43 years following an autologous IVF cycle (with or without preimplantation genetic testing for aneuploidy)
Age < 50 years following an egg donation cycle
BMI > 18 and < 30 kg/m2
blastocyst embryo transfer
Willing to participate in the study
Able to come to the Center to comply with the procedures of the study: blood tests, appointments and drug dispensation.
Exlusion Criteria:
• Uterine diseases (e.g. submucosal fibroids, polyps, previously diagnosed Müllerian abnormalities)
Hydrosalpinx
Recurrent pregnancy loss (≥ 3 previous miscarriages)
Recurrent implantation failure (≥ 3 previously failed embryo transfers of good-quality blastocysts)
Allergy to study medication
Pregnancy or lactation
Contraindication for hormonal treatment
Personalized initiation of exogenous progesterone according to a previous endometrial receptivity assay test
Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfere with the trial assessment).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nikolaos P Polyzos, MD, PhD
Phone
0034932274700
Email
nikpol@dexeus.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ignacio Rodríguez, MSc
Phone
0034932274700
Email
nacrod@dexeus.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolaos P Polyzos, MD, PhD
Organizational Affiliation
Service of Reproductive Medicine Dexeus University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Noemie Sachs-Guedj, MD
Organizational Affiliation
Service of Reproductive Medicine Dexeus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Quiron Dexeus
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolaos P Polyzos, MD PhD
Phone
0034932274700
Email
nikpol@dexeus.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Links:
URL
http://www.dexeus.com
Description
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MIcronized PROgesterone in Frozen Embryo Transfer Cycles
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