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

Instituto Bernabeu

Status: Completed

Conditions: Luteal Phase Defect

Treatments: Drug: Vaginally administered progesterone

Study type: Observational

Funder types: Other

Identifiers

NCT04722471

IB-1201

Details and patient eligibility

About

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.

Enrollment: 347 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

347 participants in 2 patient groups

400 mg

Description:

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

Treatment:

Drug: Vaginally administered progesterone

200 mg

Description:

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

Treatment:

Drug: Vaginally administered progesterone