Comparison of Two Vaginal Progesterone Forms in Frozen Embryo Transfer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-48
SponsorInstituto Valenciano de Infertilidade de Lisboa
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Vaginal progesterone soft capsules
Other interventionWhenever 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.
Vaginal progesterone pessaries
Other interventionWhenever 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Cohort 1 - vaginal progesterone soft capsules1 intervention
Group B: Cohort 2 - vaginal provesterone pessaries (ovules)1 intervention
Trial outcomes
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
Time frame
5 days after starting progesterone supplementationSecondary outcomes
1
Serum Progesterone(P4) level
Serum P4 levels collected via blood sample (as standard of care)
Time frame
5 days after starting progesterone supplementation2
Clinical pregnancy rates
Clinical pregnancy confirmation at 7 - 8 weeks gestational age, via transvaginal ultrasound
Time frame
7 - 8 weeks of gestational age3
Livebirth rates
Live birth rate, defined as the complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age
Time frame
Livebirth after 22 completed weeks of gestational ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
Instituto Valenciano de Infertilidade de Lisboa
Lead sponsor
Gedeon Richter Ltd.
Collaborator
Source ClinicalTrials.gov