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RECRUITING
NCT07461909

Comparison of Two Vaginal Progesterone Forms in Frozen Embryo Transfer

Sponsor: Instituto Valenciano de Infertilidade de Lisboa

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 48 Years

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2024-11-08

Completion Date

2026-12

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

OTHER

Vaginal progesterone soft capsules

Whenever the endometrium is above 7 mm and serum progesterone is determined and if \<1.5ng/ml, vaginal micronized progesterone soft capsules is initiated as part of routine clinical practice for luteal phase support during AC-FET or NPP-FET cycles. Typical dose: 400 mg every 12 hours (two 200 mg soft capsules). The choice of progesterone for luteal phase suport will be performed according to routine clinical practice at the discretion of both the physician and patient.

OTHER

Vaginal progesterone pessaries

Whenever the endometrium is above 7 mm and serum progesterone is determined and if \<1.5ng/ml, vaginal progesterone pessaries is initiated as part of routine clinical practice for luteal phase support during AC-FET or NPP-FET cycles. Typical dose: 400 mg every 12 hours (one 400 mg pessary). The choice of progesterone for luteal phase suport will be performed according to routine clinical practice at the discretion of both the physician and patient.

Locations (1)

Instituto Valenciano de Infertilidade (IVI Lisboa)

Lisbon, Portugal