Rescue Progesterone Supplementation During Frozen Embryo Transfer

NCT05555121 | Suspended Phase 2

• 1 other identifier: IIS-1032
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertility Issues; Embryo Implantation; Frozen Embryo Transfer

Keywords

Embryo; Frozen embryo transfer; Progesterone; Embryo implantation

Outcome Measures

Primary Outcomes (1)

• Evaluate the ongoing pregnancy rate

  Viability ultrasound

  6 to 8 weeks after Frozen Embryo Transfer

Secondary Outcomes (3)

• Evaluate the miscarriage rate

  6 to 8 weeks after Frozen Embryo Transfer

• Evaluate progesterone levels

  Before embryo transfer and 10 days after embryo transfer

• Evaluate the rate of biochemical pregnancy

  10 days after frozen embryo transfer

Other Outcomes (1)

• Blood test to evaluate the prevalence of PIBF

  Before embryo transfer and 10 days after embryo transfer

Study Arms (2)

Endometrin 100 mg three times per day (TID)

ACTIVE COMPARATOR

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

Drug: Progesterone Effervescent Vaginal Tablet

Endometrin 200 mg three times per day (TID)

ACTIVE COMPARATOR

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

Drug: Progesterone Effervescent Vaginal Tablet

Interventions

Progesterone Effervescent Vaginal Tablet DRUG

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

Also known as: Endometrin

Endometrin 100 mg three times per day (TID); Endometrin 200 mg three times per day (TID)

Eligibility Criteria

• Age: 18 Years - 42 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Ovo: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Location

MeSH Terms

Conditions

Infertility

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Wael Jamal, MD

  Clinique Ovo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single centre, prospective, open label study

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 26, 2022
• Study Start: December 1, 2022
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)