Clinical trial NCT03734770: Patient's Preferences About Subcutaneous or Vaginal Progesterone Administration for Luteal Phase Support
Official title: Patient's Preferences About Subcutaneous or Vaginal Progesterone Administration for Luteal Phase Support: Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Progesterone
Luteal Phase Support
In Vitro Fertilization
Keywords: progesterone
subcutaneous
vaginal
luteal phase support
in vitro fertilization
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 149
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized trial
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Grade of use satisfaction reported by the patients
timeFrame: At the human chorionic gonadotropin test performed after 14 days of progesterone use
measure: Grade of quality of life impairment reported by the patients
timeFrame: At the human chorionic gonadotropin test performed after 14 days of progesterone use
measure: Adverse effects (AEs)
timeFrame: At the human chorionic gonadotropin test performed after 14 days of progesterone use
Secondary outcomes:
measure: Progesterone administration route that the patients prefer
timeFrame: At the human chorionic gonadotropin test performed after 14 days of progesterone use
measure: Implantation rate
timeFrame: At the human chorionic gonadotropin test performed after 14 days of progesterone use
measure: Clinically pregnancy rate
timeFrame: At 6 week from oocyte retrieval
measure: live birth rate
timeFrame: At nine months from oocyte retrieval
Other outcomes:
Locations:
city: Verona
country: Italy
facility: AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Study officials:
affiliation: Universita di Verona
name: Simone Garzon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita di Verona
name: Rossana Di Paola, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi dell'Insubria
name: Antonio Simone Laganà
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita di Verona
name: Francesca Parissone, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: AOUI Verona
name: Stefano Zaffagnini, M.D.
role: STUDY_DIRECTOR
affiliation: Universita di Verona
name: Massimo Franchi, M.D.
role: STUDY_DIRECTOR
affiliation: Universita di Verona
name: Ricciarda Raffaelli, M.D.
role: PRINCIPAL_INVESTIGATOR
References: