NCT01430650

Brief Summary

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

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 8, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 20, 2017

Status Verified

September 1, 2017

Enrollment Period

4.3 years

First QC Date

June 20, 2011

Last Update Submit

September 19, 2017

Conditions

Sterility

Keywords

Oral estrogenstransdermal estrogensendometrial priming

Outcome Measures

Primary Outcomes (1)

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

    11-16 days

Secondary Outcomes (2)

  • Biochemical Pregnancy rate

    26-30 days

  • The patient's adherence to the recommended treatment.

    1-16 days

Study Arms (2)

Oral strogen

EXPERIMENTAL
Drug: Oral strogen

Transdermal strogen

EXPERIMENTAL
Drug: Transdermal strogen

Interventions

Oral strogenDRUG

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.

Oral strogen
Transdermal strogenDRUG

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.

Transdermal strogen

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Infertility

Interventions

IDS 89 Sabal serrulata extract

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 20, 2011

First Posted

September 8, 2011

Study Start

July 1, 2010

Primary Completion

October 1, 2014

Study Completion

July 1, 2015

Last Updated

September 20, 2017

Record last verified: 2017-09

Locations

ES(1)