Comparing two vaginal progesterone forms for frozen embryo transfer

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

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
• Enrollment: 400 (estimated)
• Ages: 18 Years to 48 Years
• Sex: Female
• Sponsor: Instituto Valenciano de Infertilidade de Lisboa (Research network)
• Locations: 1 site (Lisbon)
• Trial ID: NCT07461909 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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.

Where this trial is running

Lisbon

• 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

Conditions Frozen Embryo Transfer; Infertility; Artificial Cycle; Natural Cycle; Progesterone; Natural cycle; Natural proliferative phase; Artificial cycle