Progesterone Levels and Clinical Outcomes Using a Single Pessary of 400 mg of Vaginal Progesterone in Substitutive Cycles for Embryo Transfer.

Instituto Bernabeu347 enrolled

Overview

This study aims to compare the efficacy, in terms of progesterone levels and clinical outcomes, of two different presentations of micronized vaginal progesterone (400 mg vs. 200 mg) used in endometrial preparation in artificial cycle (AC) for embryo transfer. This is a non-inferiority, retrospective case-control study, with at least 200 cycles analyzed (at least 100 per arm) and the primary outcome is the serum progesterone level on the day of the embryo transfer.

Study Type

OBSERVATIONAL

Enrollment

347

Conditions

Luteal Phase Defect

Interventions

Vaginally administered progesteroneDRUG

The artificial endometrial preparation for an embryo transfer with the use of 400 mg vaginal tablet (one tablet twice a day) or 200 mg (two tablets twice a day)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with primary or secondary infertility undergoing endometrial preparation for an embryo transfer using standard doses of oral or transdermal estrogens. * Age between 18 and 50 years. * Normal uterine cavity verified by imaging techniques. * Serum progesterone documented on the day of embryo transfer. Exclusion Criteria: * Patients with a history of endometritis. * Patients diagnosed with Asherman's syndrome. * Patients with a different supplementation regimen or doses than those of the study groups.

Locations (1)

Instituto Bernabeu

Alicante, Valencia, Spain

Outcomes

Primary Outcomes

Serum progesterone level

Time frame: On the day of embryo transfer

Secondary Outcomes

Need for additional progesterone supplementation

Time frame: assessed on the day of the embryo transfer

Clinical results (ongoing pregnancy and miscarriage rate)

Time frame: assessed on the day of the pregnancy test and during the pregnancy evolution

Data from ClinicalTrials.gov

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