Rescue Progesterone Supplementation During Frozen Embryo Transfer (P4R)

O

Ovo Clinic

Status and phase

Active, not recruiting
Phase 2

Conditions

Frozen Embryo Transfer
Embryo Implantation
Fertility Issues

Treatments

Drug: Progesterone Effervescent Vaginal Tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT05555121
IIS-1032

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

Female

Ages

18 to 42 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Endometrin 100 mg three times per day (TID)
Active Comparator group
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
Treatment:
Drug: Progesterone Effervescent Vaginal Tablet
Endometrin 200 mg three times per day (TID)
Active Comparator group
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
Treatment:
Drug: Progesterone Effervescent Vaginal Tablet

Trial contacts and locations

1

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Central trial contact

Nelly Delouya, RN; Marion Vivien, PhD

Data sourced from clinicaltrials.gov

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