Health Trials

About this trial

The goal of this observational study is to compare two commonly used vaginal progesterone formulations - soft capsules versus pessaries - in women undergoing frozen embryo transfer (FET). The main question it aims to answer is:

\- Do soft vaginal progesterone capsules provide similar or better patient satisfaction, convenience, and tolerability compared with vaginal progesterone pessaries during preparation for frozen embryo transfer?

Participants undergoing FET who are prescribed vaginal progesterone as part of their endometrial preparation and luteal phase support will use one of the two formulations and complete patient-reported assessments regarding satisfaction, convenience, and tolerability. The study will also measure serum progesterone levels on the day of embryo transfer and evaluate pregnancy outcomes, including clinical pregnancy and live birth rates.

Eligibility criteria

Qualifiers

Age: ≥18 and <49 years old;

Body Mass Index (BMI) ≥18.5 Kg/m2 and <30 Kg/m2;

Planned for single blastocyst stage transfer;

Has been prescribed two vaginal 200mg soft capsules or one 400mg pessary of progesterone, each 12hours before and after FET;

Disqualifiers

Women who have previously enrolled in this study;

Those unable to comprehend the investigational nature of the proposed study;

Rank of FET>3;

Use of oral/injectable corticoids.

Trial design

Treatments tested in this trial

  • Vaginal progesterone soft capsules
  • Vaginal progesterone pessaries

Treatment groups

400 Participants
are divided into 2 treatment groups

Locations

1
Instituto Valenciano de Infertilidade (IVI Lisboa)1800-282, Lisbon Portugal

Sponsors and collaborators

Instituto Valenciano de Infertilidade de Lisboa

Lead sponsor

Gedeon Richter Ltd.

Collaborator

Source ClinicalTrials.gov