A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of two formulations of vaginal micronized progesterone.

Phase 3

Recruiting

• Conditions: infertility

• Registration Number: 2024-513102-57-00
• Lead Sponsor: Santiago Dexeus Font Fundacio Privada

Brief Summary

To compare the ongoing pregnancy rate following luteal phase support with standard formulation (200mg tid) and a new formulation (400mg bid) vaginal micronized progesterone in patients undergoing an AC-FET.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-04-23
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Female
• Target Recruitment: 1020

Inclusion Criteria

patients undergoing an artificial cycle-frozen embryo transfer (AC-FET)

Endometrial preparation with hormone replacement therapy

Age 18-43 years following an autologous IVF cycle (with or without preimplantation genetic testing for aneuploidy)

Age < 50 years following an egg donation cycle

BMI > 18 and < 30 kg/m2

blastocyst embryo transfer

Willing to participate in the study

Able to come to the Center to comply with the procedures of the study: blood tests, appointments and drug dispensation.

Exclusion Criteria

Uterine diseases (e.g. submucosal fibroids, polyps, previously diagnosed Müllerian abnormalities)

Hydrosalpinx

Recurrent pregnancy loss (≥ 3 previous miscarriages)

Recurrent implantation failure (≥ 3 previously failed embryo transfers of good-quality blastocysts)

Allergy to study medication

pregnancy or lactation

Contraindication for hormonal treatment

Personalized initiation of exogenous progesterone according to a previous endometrial receptivity assay test

Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfere with the trial assessment).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint is the comparison of ongoing pregnancy rate. The primary efficacy endpoint is related to the primary trial objective.		The primary efficacy endpoint is the comparison of ongoing pregnancy rate. The primary efficacy endpoint is related to the primary trial objective.

Secondary Outcome Measures

Name	Time	Method
Frequency of adverse events		Frequency of adverse events
Implantation rate		Implantation rate
Biochemical pregnancy rate		Biochemical pregnancy rate
Clinical pregnancy rate		Clinical pregnancy rate
Miscarriage rate		Miscarriage rate

Trial Locations

Locations (3)

Hospital Universitari Dexeus Grupo Quironsalud; 🇪🇸 Barcelona, Spain

Hospital Universitari General De Catalunya; 🇪🇸 Sant Cugat Del Valles, Spain

Hospital Quironsalud Del Valles; 🇪🇸 Sabadell, Spain

Hospital Universitari Dexeus Grupo Quironsalud

🇪🇸Barcelona, Spain

Nikolaos Polyzos

Site contact

0034932274700

nikpol@dexeus.com