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Clinical Trials in Portugal / NCT07461909
Recruiting Observational

Comparison of Two Vaginal Progesterone Forms in Frozen Embryo Transfer

NCT07461909 · tracked via the Priya Life Science Portugal tracker
Phase
Observational
Started
2024-11-08
Last updated
2026-03-10

Condition(s) studied

Frozen Embryo Transfer (FET)InfertilityArtificial CycleNatural Cycle

Investigational drug(s) / intervention(s)

Vaginal progesterone soft capsulesVaginal progesterone pessaries

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.

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.

Study 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

Sex
FEMALE
Min age
18 Years
Max age
48 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Instituto Valenciano de Infertilidade (IVI Lisboa) Lisbon Portugal Recruiting

More Instituto Valenciano de Infertilidade de Lisboa trials in Portugal

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07461909 on ClinicalTrials.gov ↗ ← All trials in Portugal