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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

347 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-03

Study Completion Date

2021-03-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Luteal Phase Defect

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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400 mg

Treatments where 400 mg tablet presentation of micronized vaginal progesterone was used, the protocol being one vaginal tablet twice a day.

Vaginally administered progesterone

Intervention Type DRUG

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)

200 mg

Treatments where 200 mg tablet presentation of micronized vaginal progesterone was used, the protocol being two vaginal tablets twice a day.

Vaginally administered progesterone

Intervention Type DRUG

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)

Interventions

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Vaginally administered progesterone

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)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes