Patient's Preferences About Subcutaneous or Vaginal Progesterone Administration for Luteal Phase Support (PROPER-1)

University of Verona

Status: Completed

Conditions: In Vitro Fertilization; Progesterone; Luteal Phase Support

Treatments: Drug: Subcutaneous Progesterone; Drug: Vaginal progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT03734770

PROPER-1

Details and patient eligibility

About

Luteal phase support in "in vitro fertilization" (IVF) cycles has been shown to improve pregnancy rates and became a standard of treatment, and progesterone is the first choice considering its safety profile and effectiveness. There are many studies demonstrating that vaginal progesterone is equally efficacious and better tolerated compared to intramuscular progesterone for luteal phase support in IVF cycles. Conversely, although different studies showed that subcutaneous progesterone is equally efficacious compared to vaginal progesterone, patient use satisfaction and compliance were less studied with few evidences are available, that may guide the choice of vaginal progesterone instead of subcutaneous progesterone and other way around. Considering the paucity of published data about the patient's preference and use satisfaction about subcutaneous progesterone, the investigators will conduct a prospective randomized study aimed to compared adverse effects rates, impact on quality of life, use satisfaction and administration preference in women undergoing luteal phase support with vaginal progesterone versus subcutaneous progesterone during IVF cycles, that may guide the choice for luteal phase support in IVF cycles.

Enrollment: 149 patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Infertile women candidate to undergo fresh IVF cycles

Exclusion criteria

• day-3 follicle-stimulating hormone (FSH) levels over 15 IU/L
• clinically relevant systemic disease (e.g., uncontrolled thyroid and adrenal dysfunction, an organic intracranial lesion such as a pituitary tumor, insulin-dependent diabetes mellitus, cancers)
• hypersensitivity to any of the study drugs
• contraindications to use the study drugs
• surgical or medical condition that would interfere with absorption, distribution, metabolism, or excretion of the study drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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149 participants in 2 patient groups

Subcutaneous progesterone

Active Comparator group

Description:

After standard stimulating protocol for IVF, beginning on the day of oocyte retrieval allocated patients receive subcutaneous progesterone (Pleyris, IBSA Farmaceutici, Italia) 25 mg one time per day (every day at the same time, according to patient's availability and preference) for at least 8 gestational weeks or confirmation of a negative pregnancy test performed 14 days after oocyte retrieval.

Treatment:

Drug: Subcutaneous Progesterone

Vaginal progesterone

Active Comparator group

Description:

After standard stimulating protocol for IVF, beginning on the day of oocyte retrieval allocated patients receive micronized vaginal progesterone (Progeffik, EFFIK Spa, Italia) 200 mg three times per day (every 8 hours) for at least 8 gestational weeks or confirmation of a negative pregnancy test performed 14 days after oocyte retrieval.

Treatment:

Drug: Vaginal progesterone