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

Study Overview
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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.

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

Conditions
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Luteal Phase Defect

Intervention / Treatment
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* Drug: Vaginally administered progesterone


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 400 mg<br>Treatments where 400 mg tablet presentation of micronized vaginal progesterone was used, the protocol being one vaginal tablet twice a day. | Drug: Vaginally administered progesterone<br>* 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)<br>|
| 200 mg<br>Treatments where 200 mg tablet presentation of micronized vaginal progesterone was used, the protocol being two vaginal tablets twice a day. | Drug: Vaginally administered progesterone<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum progesterone level |  | On the day of embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for additional progesterone supplementation |  | assessed on the day of the embryo transfer | 
| Clinical results (ongoing pregnancy and miscarriage rate) |  | assessed on the day of the pregnancy test and during the pregnancy evolution | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frozen embryo transfer, endometrial preparation, artificial cycle, progesterone