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OpenTrials
Completed

NCT Number: NCT04722471

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

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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Key information

Conditions

Luteal Phase Defect

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Instituto Bernabeu

Alicante, Valencia, 03016, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vaginally administered progesterone

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)

Primary outcomes

  1. Serum progesterone level

    Time frame: On the day of embryo transfer

Secondary outcomes

  1. Need for additional progesterone supplementation

    Time frame: assessed on the day of the embryo transfer

  2. Clinical results (ongoing pregnancy and miscarriage rate)

    Time frame: assessed on the day of the pregnancy test and during the pregnancy evolution

Sponsors and collaborators

Lead sponsor

Instituto Bernabeu

Other

Registry information

Acronym: CycloCT

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 25, 2021
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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