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

Sponsor

Universita di Verona (Other)

Overall Status

Completed

CT.gov ID

NCT03734770

Collaborator

(none)

149

Enrollment

Location

Arms

5.9

Actual Duration (Months)

25.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Progesterone Luteal Phase Support In Vitro Fertilization	Drug: Subcutaneous Progesterone Drug: Vaginal progesterone	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

149 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective randomized trialProspective randomized trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Patient's Preferences About Subcutaneous or Vaginal Progesterone Administration for Luteal Phase Support: Prospective Randomized Trial.

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Subcutaneous progesterone 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.	Drug: Subcutaneous Progesterone 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).
Active Comparator: Vaginal progesterone 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.	Drug: Vaginal progesterone Micronized vaginal progesterone (Progeffik, EFFIK Spa, Italia) 200 mg three times per day (every 8 hours).

Arm

Intervention/Treatment

Active Comparator: Subcutaneous progesterone

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.

Drug: Subcutaneous Progesterone

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).

Active Comparator: Vaginal progesterone

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.

Drug: Vaginal progesterone

Micronized vaginal progesterone (Progeffik, EFFIK Spa, Italia) 200 mg three times per day (every 8 hours).

Outcome Measures

Primary Outcome Measures

Grade of use satisfaction reported by the patients [At the human chorionic gonadotropin test performed after 14 days of progesterone use]
Patients will be asked how satisfied they are by the use of progesterone product that they receive in the luteal phase. Their satisfaction responses will be recorded on a scale of 1 to 3, with 1 being ''least satisfied'' and 3 being ''most satisfied'.
Grade of quality of life impairment reported by the patients [At the human chorionic gonadotropin test performed after 14 days of progesterone use]
Patients will be asked whether work life, social life, sexual life, and personal hygiene are perceived impaired by the progesterone treatment that they received. The answer for each item is "yes" or "no".
Adverse effects (AEs) [At the human chorionic gonadotropin test performed after 14 days of progesterone use]
Patients will be asked to report experienced AEs. The investigated AEs are sleepiness, dizziness, headache, bowel dysfunctions, breast pain/tension, weight changes, mood disorders, skin irritation, and vaginal discharge. The answer for each item is "yes" or "no".

Secondary Outcome Measures

Progesterone administration route that the patients prefer [At the human chorionic gonadotropin test performed after 14 days of progesterone use]
Patients of subcutaneous progesterone arm and who had previously used vaginal progesterone will be asked which administration route they prefer.
Implantation rate [At the human chorionic gonadotropin test performed after 14 days of progesterone use]
Rate of positive human chorionic gonadotropin test
Clinically pregnancy rate [At 6 week from oocyte retrieval]
Rate of evolving pregnancy at ultrasound
live birth rate [At nine months from oocyte retrieval]
Rate of baby delivered after 24 gestational weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 43 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOUI Verona - University of Verona - Department of Obstetrics and Gynecology	Verona		Italy	37125

Sponsors and Collaborators

Universita di Verona

Investigators

Principal Investigator: Simone Garzon, M.D., Universita di Verona
Principal Investigator: Rossana Di Paola, M.D., Universita di Verona
Principal Investigator: Antonio Simone Laganà, Università degli Studi dell'Insubria
Principal Investigator: Francesca Parissone, M.D., Universita di Verona
Study Director: Stefano Zaffagnini, M.D., AOUI Verona
Study Director: Massimo Franchi, M.D., Universita di Verona
Principal Investigator: Ricciarda Raffaelli, M.D., Universita di Verona