Endometrial Priming for Embryo Transfer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01430650
First received: June 20, 2011
Last updated: November 2, 2015
Last verified: November 2015
  Purpose

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

  • women that receive oral estrogens
  • women that receive transdermal estrogens

Condition Intervention Phase
Sterility
Drug: Oral strogen
Drug: Transdermal strogen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Control Trial to Evaluate Efficacy and Safety of Two Different Protocols of Endometrial Priming for Embryo Transfer.

Further study details as provided by Parc de Salut Mar:

Primary Outcome Measures:
  • Difference between day means in endometrial priming to achieve 7 mm. [ Time Frame: 11-16 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical Pregnancy rate [ Time Frame: 26-30 days ] [ Designated as safety issue: No ]
    To calculate the biochemical pregnancy rate, we will divide the number of biochemical pregnancy into the number of embryonary transference and multiply by 100.

  • The patient's adherence to the recommended treatment. [ Time Frame: 1-16 days ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: July 2010
Study Completion Date: July 2015
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral strogen Drug: Oral strogen
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.
Experimental: Transdermal strogen Drug: Transdermal strogen
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430650

Locations
Spain
Hospital del Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar
  More Information

Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01430650     History of Changes
Other Study ID Numbers: UREP-PREPENDO-2010 
Study First Received: June 20, 2011
Last Updated: November 2, 2015
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Parc de Salut Mar:
Oral estrogens
transdermal estrogens
endometrial priming

Additional relevant MeSH terms:
Permixon
Androgen Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2016