Comparison of Two Vaginal Progesterone Forms in Frozen Embryo Transfer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-48
SponsorInstituto Valenciano de Infertilidade de Lisboa
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 groupsSponsors and collaborators
Instituto Valenciano de Infertilidade de Lisboa
Lead sponsor
Gedeon Richter Ltd.
Collaborator
Source ClinicalTrials.gov