Infertility Clinical Trials

Find Infertility Clinical Trials Near You

Comparison of Patient Satisfaction, Convenience and Tolerability Between Two Vaginal Progesterone Formulations During Frozen Embryo Transfer

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 48
Healthy Volunteers: f
View:

• 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;

• Either AC-FET or NPP-FET.

Locations
Other Locations
Portugal
Instituto Valenciano de Infertilidade (IVI Lisboa)
RECRUITING
Lisbon
Contact Information
Primary
Samuel Ribeiro
Samuel.Ribeiro@ivirma.com
+351 218503210
Backup
Belisa Silva
Belisa.Silva@ivirma.com
+351 218503210
Time Frame
Start Date: 2024-11-08
Estimated Completion Date: 2026-12
Participants
Target number of participants: 400
Treatments
Cohort 1 - vaginal progesterone soft capsules
Women undergoing FET who receive soft vaginal progesterone capsules (micronized progesterone 200 mg x 2 capsules every 12 h = 400 mg/12h) for endometrial preparation/luteal support as per routine care.
Cohort 2 - vaginal provesterone pessaries (ovules)
Women undergoing FET who receive vaginal progesterone pessaries (400 mg x 1 pessary every 12 h) for endometrial preparation/luteal support as per routine care.
Related Therapeutic Areas
Sponsors
Leads: Instituto Valenciano de Infertilidade de Lisboa
Collaborators: Gedeon Richter Ltd.

This content was sourced from clinicaltrials.gov