Comparing two vaginal progesterone forms for frozen embryo transfer
Official title: Comparison of Patient Satisfaction, Convenience and Tolerability Between Two Vaginal Progesterone Formulations During Frozen Embryo Transfer
Run by Instituto Valenciano de Infertilidade de Lisboa · NCT07461909 · Data updated 2026-11-12
This compares whether soft vaginal progesterone capsules are easier to use, better tolerated, and give similar pregnancy results as vaginal progesterone pessaries for women having frozen embryo transfer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 48 Years |
| Sex | Women only |
| Enrollment | 400 (estimated) |
| Sponsor | Instituto Valenciano de Infertilidade de Lisboa Research network |
| Locations | 1 site (Lisbon) |
| Status | Recruiting |
| Started | November 8, 2024 |
| Main results expected | August 2026 |
| Study ends | December 2026 |
| Registry record updated | March 10, 2026 |
| Trial ID | NCT07461909 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–48 with BMI 18.5–29.9 planning a single blastocyst frozen embryo transfer and prescribed either two 200 mg vaginal progesterone capsules or one 400 mg vaginal progesterone pessary in AC-FET or NPP-FET cycles are ideal candidates.
✕Probably not a fit
People outside the age or BMI limits, those with more than three prior FETs, current oral/injectable corticosteroid use, inability to consent, or not using vaginal progesterone would not be expected to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study follows women undergoing frozen embryo transfer who are prescribed either vaginal progesterone soft capsules or vaginal progesterone pessaries as luteal support in artificial or natural proliferative phase cycles. Participants use the prescribed formulation and complete patient-reported questionnaires on satisfaction, convenience, and tolerability. Serum progesterone levels will be measured on the day of embryo transfer and clinical pregnancy and live birth outcomes will be recorded. The non-randomized design compares real-world patient experience, biochemical levels, and pregnancy endpoints between the two formulations.
Why it matters
Potential benefit: If soft capsules prove more comfortable or convenient without reducing pregnancy rates, patients could have better tolerability and adherence during frozen embryo transfer cycles.
How similar studies have gone: Prior research comparing vaginal progesterone routes and formulations has often found similar serum levels and pregnancy outcomes, but direct head-to-head data on soft capsules versus pessaries and detailed patient satisfaction comparisons are limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Instituto Valenciano de Infertilidade (IVI Lisboa)
Lisbon, Portugal Recruiting
Study contacts
- Principal investigator: Samuel Ribeiro — Instituto Valenciano de Infertilidade de Lisboa (IVI Lisboa)
- Study coordinator: Samuel Ribeiro
- Email: Samuel.Ribeiro@ivirma.com
- Phone: +351 218503210
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.