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OpenTrials
Completed

NCT Number: NCT03725904

Daytime Profile of Salivary Progesterone

The aim of this study is to perform a 12-hour profile of free saliva progesterone during the luteal phase after fresh and frozen embryo transfer. If progesterone levels in saliva samples show a constant level during daytime, this non-invasive measurement can be used in future ART patients with insufficient progesterone levels who might benefit from additional exogenous progesterone supplementation.

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fertility Clinic Regional Hospital Skive

Skive, 7800, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18-45 years
  • One or two good quality embryos for transfer on day 5.
  • BMI >18,5 <30 kg/m²

Exclusion criteria

  • No good quality embryos for transfer
  • Uterine abnormalities
  • One ovary
  • Oocyte donation

Treatment and study plan

Progesterone analysis in saliva

Diagnostic Test

Analysis of salava progesterone

Primary outcomes

  1. Levels of free progesterone in saliva

    Time frame: 12 hours

Secondary outcomes

  1. Clinical pregnancy rate

    Time frame: 8 weeks

    Ultrasound detected gestational sack divided with number of embryo transfer

  2. Ongoing pregnancy rate

    Time frame: 12 weeks

    Viable pregnancy after gestational week 12+0

Sponsors and collaborators

Lead sponsor

Peter Humaidan

Other

Collaborators

  • Boston IVF

Registry information

Official study title

Daytime Profile of Salivary Progesterone During the Mid-luteal Phase of IVF and FET Cycles

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 31, 2018
Registry last updated
Jan 22, 2020

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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