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

Completed

• Conditions: Luteal Phase Defect
• Interventions: Drug: Vaginally administered progesterone

• Registration Number: NCT04722471
• Lead Sponsor: Instituto Bernabeu

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-25
• Status Verified: 2021-03
• Study Start: 2021-03-03
• Primary Completion: 2021-03-03
• Study Completion: 2021-03-17
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 347

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
200 mg	Vaginally administered progesterone	Treatments where 200 mg tablet presentation of micronized vaginal progesterone was used, the protocol being two vaginal tablets twice a day.
400 mg	Vaginally administered progesterone	Treatments where 400 mg tablet presentation of micronized vaginal progesterone was used, the protocol being one vaginal tablet twice a day.

Primary Outcome Measures

Name	Time	Method
Serum progesterone level	On the day of embryo transfer

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Instituto Bernabeu; 🇪🇸 Alicante, Comunidad Valenciana, Spain