Comparison of Two Vaginal Progesterone Forms in Frozen Embryo Transfer
Comparison of Patient Satisfaction, Convenience and Tolerability Between Two Vaginal Progesterone Formulations During Frozen Embryo Transfer
Instituto Valenciano de Infertilidade de Lisboa
400 participants
Nov 8, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria4
- 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.
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Interventions
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.
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.
Locations(1)
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NCT07461909