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Rescue Progesterone Supplementation During Frozen Embryo Transfer (P4R)

Primary Purpose

Fertility Issues, Embryo Implantation, Frozen Embryo Transfer

Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Progesterone Effervescent Vaginal Tablet
Sponsored by
Clinique Ovo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fertility Issues focused on measuring Embryo, Frozen embryo transfer, Progesterone, Embryo implantation

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women 18-42 years of age
  • Normal uterine cavity (according to treating physician)
  • FET substituted cycle prescribed
  • First or second cycle of FET
  • Adequate endometrial pattern (triple layer) and thickness (>7 mm) after adequate standard endometrial preparation in artificial cycle

Exclusion Criteria:

  • Any uterine abnormalities confirmed by treating physician making participant unable to proceed with FET
  • Patients with personalized FET according to the endometrial receptivity assay tests
  • Previous allergic reactions to progesterone or any of the ingredients of Endometrin
  • Severe hepatic dysfunction or disease
  • Known or suspected breast cancer or genital tract cancer
  • Known active arterial or venous thromboembolism or severe thrombophlebitis or cerebro-vascular disease, or a history of these events
  • Diagnosed porphyria
  • Undiagnosed abnormal vaginal bleeding
  • Known missed abortion or ectopic pregnancy
  • Recurrent pregnancy loss excluding biochemical pregnancies
  • Hypersensitivity to Acetylsalicylic acid (ASA), salicylates, non-steroidal anti-inflammatory drugs (NSAIDs), analgesics, antipyretics or other ingredients in the product or component of the container
  • Acute gastrointestinal ulcer, history of gastrointestinal ulcers and hemorrhagic diathesis
  • Active or severe renal disease, or congestive heart failure
  • History of asthma induced by salicylates or other NSAIDs
  • Use of methotrexate at doses of 15mg/week or more
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency

Sites / Locations

  • Clinique OvoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Endometrin 100 mg three times per day (TID)

Endometrin 200 mg three times per day (TID)

Arm Description

Women with progesterone levels ≥ 8.8 ng/ml during frozen embryo transfer cycle will take Endometrin 100 mg TID until 10th week of pregnancy

Women with progesterone levels < 8.8 ng/ml during frozen embryo transfer cycle will take Endometrin 200 mg TID until 10th week of pregnancy

Outcomes

Primary Outcome Measures

Evaluate the ongoing pregnancy rate
Viability ultrasound

Secondary Outcome Measures

Evaluate the miscarriage rate
Viability ultrasound
Evaluate progesterone levels
Progesterone levels will be tested at two different times
Evaluate the rate of biochemical pregnancy
Serum pregnancy test to measure Beta Human Chorionic Gonadotropin (BhCG) levels

Full Information

First Posted
September 16, 2022
Last Updated
December 22, 2022
Sponsor
Clinique Ovo
Collaborators
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05555121
Brief Title
Rescue Progesterone Supplementation During Frozen Embryo Transfer
Acronym
P4R
Official Title
Rescue Progesterone Supplementation in Patients With Low Progesterone on the Day of Embryo Transfer for Artificial Endometrial Preparation Cycles: a Non-inferiority Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinique Ovo
Collaborators
Ferring Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Endometrin is a progesterone supplement prescribed during in vitro fertilization (IVF) for preparation for embryo transfer. The usual dose of Endometrin is 100 mg two to three times per day in the form of an effervescent tablet to be inserted vaginally. The purpose of this research project is to evaluate the dose response of the Endometrin when determined based on the blood level of progesterone on the day of the FET. According to the literature, a predefined level of progesterone in the blood should be reached in order to have favorable conditions for pregnancy. The hypothesis being that a woman with low progesterone levels would benefit from a dose of Endometrin of 600 mg (200 mg 3x/day) to decrease the risk of miscarriage and improve the chances of pregnancy. Women with adequate progesterone levels according to the literature, would continue with the standard dose of progesterone prescribed at clinique ovo which is 300 mg (100 mg 3x/day). PIBF (Progesterone Induced Blocking Factor) levels, a protein found in the blood that could also predict pregnancy outcomes in women using IVF will also be looked at.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fertility Issues, Embryo Implantation, Frozen Embryo Transfer
Keywords
Embryo, Frozen embryo transfer, Progesterone, Embryo implantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Single centre, prospective, open label study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endometrin 100 mg three times per day (TID)
Arm Type
Active Comparator
Arm Description
Women with progesterone levels ≥ 8.8 ng/ml during frozen embryo transfer cycle will take Endometrin 100 mg TID until 10th week of pregnancy
Arm Title
Endometrin 200 mg three times per day (TID)
Arm Type
Active Comparator
Arm Description
Women with progesterone levels < 8.8 ng/ml during frozen embryo transfer cycle will take Endometrin 200 mg TID until 10th week of pregnancy
Intervention Type
Drug
Intervention Name(s)
Progesterone Effervescent Vaginal Tablet
Other Intervention Name(s)
Endometrin
Intervention Description
On the day of Frozen Embryo Transfer (FET), women will have a blood test to determine progesterone levels. Depending on the result of progesterone level, the participant will be assigned to either the Endometrin 100 mg TID dose or the Endometrin 200 mg TID dose
Primary Outcome Measure Information:
Title
Evaluate the ongoing pregnancy rate
Description
Viability ultrasound
Time Frame
6 to 8 weeks after Frozen Embryo Transfer
Secondary Outcome Measure Information:
Title
Evaluate the miscarriage rate
Description
Viability ultrasound
Time Frame
6 to 8 weeks after Frozen Embryo Transfer
Title
Evaluate progesterone levels
Description
Progesterone levels will be tested at two different times
Time Frame
Before embryo transfer and 10 days after embryo transfer
Title
Evaluate the rate of biochemical pregnancy
Description
Serum pregnancy test to measure Beta Human Chorionic Gonadotropin (BhCG) levels
Time Frame
10 days after frozen embryo transfer
Other Pre-specified Outcome Measures:
Title
Blood test to evaluate the prevalence of PIBF
Description
Progesterone Inducing Blocking Factor (PIBF) has been found to to have an important part in creating a welcoming environment for the embryo
Time Frame
Before embryo transfer and 10 days after embryo transfer

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women 18-42 years of age Normal uterine cavity (according to treating physician) FET substituted cycle prescribed First or second cycle of FET Adequate endometrial pattern (triple layer) and thickness (>7 mm) after adequate standard endometrial preparation in artificial cycle Exclusion Criteria: Any uterine abnormalities confirmed by treating physician making participant unable to proceed with FET Patients with personalized FET according to the endometrial receptivity assay tests Previous allergic reactions to progesterone or any of the ingredients of Endometrin Severe hepatic dysfunction or disease Known or suspected breast cancer or genital tract cancer Known active arterial or venous thromboembolism or severe thrombophlebitis or cerebro-vascular disease, or a history of these events Diagnosed porphyria Undiagnosed abnormal vaginal bleeding Known missed abortion or ectopic pregnancy Recurrent pregnancy loss excluding biochemical pregnancies Hypersensitivity to Acetylsalicylic acid (ASA), salicylates, non-steroidal anti-inflammatory drugs (NSAIDs), analgesics, antipyretics or other ingredients in the product or component of the container Acute gastrointestinal ulcer, history of gastrointestinal ulcers and hemorrhagic diathesis Active or severe renal disease, or congestive heart failure History of asthma induced by salicylates or other NSAIDs Use of methotrexate at doses of 15mg/week or more Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nelly Delouya, RN
Phone
5147982000
Ext
759
Email
n.delouya@cliniqueovo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marion Vivien, PhD
Phone
5147982000
Ext
627
Email
m.vivien@cliniqueovo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wael Jamal, MD
Organizational Affiliation
Clinique Ovo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Ovo
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4P 2S4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nelly Delouya, RN
Phone
5147982000
Ext
759
Email
n.delouya@cliniqueovo.com
First Name & Middle Initial & Last Name & Degree
Wael Jamal, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Rescue Progesterone Supplementation During Frozen Embryo Transfer

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