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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.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04722471
Acronym
CycloCT
Enrollment
347
Registered
2021-01-25
Start date
2021-03-03
Completion date
2021-03-17
Last updated
2021-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Luteal Phase Defect

Keywords

Frozen embryo transfer, endometrial preparation, artificial cycle, progesterone

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.

Interventions

DRUGVaginally 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)

Sponsors

Instituto Bernabeu
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Serum progesterone levelOn the day of embryo transfer

Secondary

MeasureTime frame
Need for additional progesterone supplementationassessed 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026