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Completed

NCT Number: NCT01430650

Endometrial Priming for Embryo Transfer

The aim of this trial is compare two different endometrial priming protocols

* women that receive oral estrogens * women that receive transdermal estrogens

Completed

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Key information

Conditions

Sterility Genital Diseases Infertility Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital del Mar

Barcelona, 08003, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women between 18-50 years old with desire of children and needs of embryo transfer.
  • Plasma prolactin less than 30.
  • Uterine cavity that allow pregnancy, body mass index between 20-30.
  • And signed consent inform.

Exclusion criteria

  • History of estrogen dependent cancer, unknown origin vaginal bleeding.
  • Ovarian cyst.
  • Contraindications to be pregnant.
  • Estrogen allergy.

Treatment and study plan

Oral strogen

Drug

2 mg of estradiol every day beginning the second day of the cycle until day 7. 4 mg of estradiol every day beginning 8th day of the cycle until day 10. 6 mg of estradiol every day beginning 11th day of the cycle until day 16.

Transdermal strogen

Drug

One patch of 75 mcg of estradiol hemimydrate every 48 h from 2 to day 6. Two patches of 75 mcg of estradiol hemimydrate every 48 h from 6 to day 12. Three patches of 75 mcg of estradiol hemimydrate every 48 h from 12 to day 16.

Primary outcomes

  1. Difference between day means in endometrial priming to achieve 7 mm.

    Time frame: 11-16 days

Secondary outcomes

  1. Biochemical Pregnancy rate

    Time frame: 26-30 days

    To calculate the biochemical pregnancy rate, we will divide the number of biochemical pregnancy into the number of embryonary transference and multiply by 100.

  2. The patient's adherence to the recommended treatment.

    Time frame: 1-16 days

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

A Randomised Control Trial to Evaluate Efficacy and Safety of Two Different Protocols of Endometrial Priming for Embryo Transfer.

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Sep 8, 2011
Registry last updated
Sep 20, 2017

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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