Comparison of Two Vaginal Progesterone Forms in Frozen Embryo Transfer

NCT07461909 | Recruiting

• 1 other identifier: 2306-LIS-122-SS
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Frozen Embryo Transfer (FET); Infertility; Artificial Cycle; Natural Cycle

Keywords

Progesterone; Natural cycle; Natural proliferative phase (NPP-FET); Artificial cycle (AC-FET); Patient satisfaction; Frozen embryo transfer; Assisted reproduction; Endometrial preparation; Treatment tolerability

Outcome Measures

Primary Outcomes (1)

• Compare the patients' satisfaction, convenience and tolerability of two common vaginal progesterone formulations: soft capsules versus pessaries

  Satisfaction levels, convenience and tolerability will be collected using a GDPR compliant online survey tool, filled by participants

  5 days after starting progesterone supplementation

Secondary Outcomes (3)

• Serum Progesterone(P4) level

  5 days after starting progesterone supplementation

• Clinical pregnancy rates

  7 - 8 weeks of gestational age

• Livebirth rates

  Livebirth after 22 completed weeks of gestational age

Study Arms (2)

Cohort 1 - vaginal progesterone soft capsules

Women undergoing FET who receive soft vaginal progesterone capsules (micronized progesterone 200 mg x 2 capsules every 12 h = 400 mg/12h) for endometrial preparation/luteal support as per routine care.

Other: Vaginal progesterone soft capsules

Cohort 2 - vaginal provesterone pessaries (ovules)

Women undergoing FET who receive vaginal progesterone pessaries (400 mg x 1 pessary every 12 h) for endometrial preparation/luteal support as per routine care.

Other: Vaginal progesterone pessaries

Interventions

Vaginal progesterone soft capsules OTHER

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.

Cohort 1 - vaginal progesterone soft capsules

Vaginal progesterone pessaries OTHER

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.

Cohort 2 - vaginal provesterone pessaries (ovules)

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of women aged 18 to 48 years undergoing frozen embryo transfer (FET) at IVI Lisboa. Eligible participants must have a BMI between 18.5 and \<30 kg/m², be scheduled for a single blastocyst-stage transfer, and be prescribed vaginal progesterone for luteal phase support, either soft capsules (400 mg every 12 hours) or pessaries (400 mg every 12 hours). Both artificial cycle (AC-FET) and natural proliferative phase (NPP-FET) protocols are included. The study population reflects real-world patients receiving routine clinical care.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Valenciano de Infertilidade de Lisboa: lead
• Gedeon Richter Ltd.: collaborator

Study Sites (1)

Instituto Valenciano de Infertilidade (IVI Lisboa)

Lisbon, 1800-282, Portugal

RECRUITING

MeSH Terms

Conditions

Infertility; Patient Satisfaction

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Samuel Ribeiro

  Instituto Valenciano de Infertilidade de Lisboa (IVI Lisboa)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Ribeiro

CONTACT

+351 218503210; Samuel.Ribeiro@ivirma.com

Belisa Silva

CONTACT

+351 218503210; Belisa.Silva@ivirma.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: March 10, 2026
• Study Start: November 8, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

PT (1)