NCT07461909 Comparison of Two Vaginal Progesterone Forms in Frozen Embryo Transfer
| NCT ID | NCT07461909 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto Valenciano de Infertilidade de Lisboa |
| Condition | Frozen Embryo Transfer (FET) |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-11-08 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2024-11-08 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Samuel Ribeiro
PRINCIPAL INVESTIGATOR
Instituto Valenciano de Infertilidade de Lisboa (IVI Lisboa)
Frequently Asked Questions
Who can join the NCT07461909 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 48 Years, studying Frozen Embryo Transfer (FET). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07461909 currently recruiting?
Yes, NCT07461909 is actively recruiting participants. Contact the research team at Samuel.Ribeiro@ivirma.com for enrollment information.
Where is the NCT07461909 trial being conducted?
This trial is being conducted at Lisbon, Portugal.
Who is sponsoring the NCT07461909 clinical trial?
NCT07461909 is sponsored by Instituto Valenciano de Infertilidade de Lisboa. The principal investigator is Samuel Ribeiro at Instituto Valenciano de Infertilidade de Lisboa (IVI Lisboa). The trial plans to enroll 400 participants.