NCT02567552

Brief Summary

Study the endometrial predecidualization by using subcutaneous progesterone 25 mg/day versus intramuscular progesterone 50 mg/day, to determine whether there are differences in the endometrial transformation and endometrial receptivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2015

Shorter than P25 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

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

March 19, 2018

Completed
Last Updated

December 16, 2019

Status Verified

February 1, 2019

Enrollment Period

7 months

First QC Date

October 2, 2015

Results QC Date

February 23, 2017

Last Update Submit

December 13, 2019

Conditions

Reproductive Techniques, Assisted

Keywords

endometrial receptivityendometrial predecidualizationendometrial genomicsendometrial receptivity array

Outcome Measures

Primary Outcomes (5)

  • Predecidual Transformation

    Histologic dating of the endometrium at day 5: early secretory phase, media secretory phase or late secretory phase

    5 days

  • Decidualization of Stromal Cell

    Rate of transformation of endometrial stromal fibroblasts into specialized secretory decidual cells (three categories: less than 25%, between 26% and 50%, and over 50%)

    5 days

  • Endometrial Maturation Using Noyes' Criteria

    Endometrial dating of luteal phase days according to the Noyes criteria

    5 days

  • Endometrial Gene Expression

    Gene expression profile of endometrial

    5 days

  • Endometrial Gene Expression Difference

    Genes with a significantly high gene expression difference (adj-p-value \< 0.05, Fold Change\>3)

    5 days

Secondary Outcomes (8)

  • Endometrial Thickness

    5 days

  • Blood Estradiol Level

    day 0

  • Blood Progesterone Level

    day 0

  • Blood LH Level

    day 0

  • Blood Estradiol Level

    5 days

  • +3 more secondary outcomes

Study Arms (2)

Prolutex

EXPERIMENTAL

Subcutaneous progesterone

Drug: Subcutaneous progesterone

Prontogest

ACTIVE COMPARATOR

Intramuscular progesterone

Drug: Intramuscular progesterone

Interventions

Subcutaneous progesteroneDRUG

subcutaneous progesterone 25 mg/day

Also known as: Prolutex
Prolutex
Intramuscular progesteroneDRUG

intramuscular progesterone 50 mg/day

Also known as: Prontogest
Prontogest

Eligibility Criteria

Age18 Years - 34 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female aged between 18 and 34 years
  • BMI between 18 and 28 kg/m2
  • Endometrial thickness \> 7 mm the day of progesterone treatment initiation (day of follicular puncture)
  • Follicular maturation with a single bolus of GnRH agonist
  • Egg donors who undergo a cycle of ovarian stimulation in the IVI Barcelona Centre
  • Egg donors selected in accordance with the requirements of Law 14/2006 of 26 May 2006 on Assisted Human Reproduction Techniques
  • Informed consent has been signed and dated

You may not qualify if:

  • Known allergy to progesterone formulations or their excipients
  • Known allergy to estrogens
  • Known thrombophilias
  • Alcohol, drug or psychotropic medication dependence
  • Concurrent participation in another study
  • Concomitant medication that may interfere with the study medication and ovarian stimulation
  • Failure to comply with the requirements for egg donors in accordance with Law 14/2006 of 26 May 2006 on Assisted Human Reproduction Techniques

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Barcelona

Barcelona, 08017, Spain

Location

MeSH Terms

Conditions

Helping Behavior

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Results Point of Contact

Title
Evelin Lara Molina
Organization
IVI Barcelona
Evelin.Lara@ivi.es
+34 93 531 63 00

Study Officials

  • Agustín B Boluda

    IVI Barcelona

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Masked samples for histological evaluation and assessment of gene expression
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2015

First Posted

October 5, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

December 16, 2019

Results First Posted

March 19, 2018

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)