NCT04733235

Brief Summary

The purpose of this prospective cohort study is to assess the effect of endometrial compaction caused by progesterone effect on pregnancy outcomes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
205

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

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, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

January 3, 2023

Status Verified

December 1, 2022

Enrollment Period

10 months

First QC Date

January 17, 2021

Last Update Submit

December 29, 2022

Conditions

InfertilityFemale InfertilityFrozen-thawed Embryo Transfer

Keywords

infertilityfemale infertilityfrozen- thawed embryo transferfemale

Outcome Measures

Primary Outcomes (2)

  • The change in endometrial thickness

    changing in millimeters of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.

    1 year

  • ongoing pregnancy rates.

    pregnancy beyond 12 weeks of gestational age.

    1 year

Secondary Outcomes (4)

  • The Correlation of Serum Progesterone Levels With the Degree of Endometrial Compaction on the Day of Frozen Embryo Transfer

    On the day of frozen embryo transfer

  • Clinical pregnancy rate

    6-7 weeks after the last menstrual period of the patient

  • Implantation rate

    5 weeks after the last menstrual period of the patient

  • Clinical miscarriage

    after 5th gestational week

Study Arms (2)

with endometrial compaction

Participants who have endometrial compaction caused by progesterone effects on undergoing frozen embryo transfer with artificial hormone replacement

Drug: Progesterone

without endometrial compaction

Participants who have not endometrial compaction caused by progesterone effects on undergoing frozen embryo transfer with artificial hormone replacement

Drug: Progesterone

Interventions

ProgesteroneDRUG

ultrasound measurements of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.

Also known as: Diagnostic Test: Blood test Measurement of E2, P4, LH, FSH hormones Diagnostic Test: Transvaginal
with endometrial compactionwithout endometrial compaction

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients underwent infertility treatment
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women underwent frozen embryo transfer

You may qualify if:

  • Woman aged 18-40 years
  • Presence of high quality (\>2BB) blastocyst
  • Hormonal(estrogen and progesterone) frozen- thawed embryo transfer cycles
  • presence of high quality blastocyst cryopreserved by vitrification method.
  • A single embryo transfer

You may not qualify if:

  • Presence of uterine pathology
  • Participants whose optimal endometrial image cannot be obtained due to uterine position
  • Participants whose treatments were canceled for any reason before embryo transfer
  • Participants which had embryo transfer on the day 2 or 3 (at the cleavage stage)
  • Participants who had 2 embryo transfer
  • Presence of low quality (\<2BB) blastocyst
  • \> 15% loss of viability in the embryo during embryo thawing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

Related Publications (1)

  • Haas J, Smith R, Zilberberg E, Nayot D, Meriano J, Barzilay E, Casper RF. Endometrial compaction (decreased thickness) in response to progesterone results in optimal pregnancy outcome in frozen-thawed embryo transfers. Fertil Steril. 2019 Sep;112(3):503-509.e1. doi: 10.1016/j.fertnstert.2019.05.001. Epub 2019 Jun 24.

    PMID: 31248618RESULT

MeSH Terms

Conditions

InfertilityInfertility, Female

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOCIATE PROFESSOR

Study Record Dates

First Submitted

January 17, 2021

First Posted

February 2, 2021

Study Start

July 1, 2020

Primary Completion

April 15, 2021

Study Completion

July 15, 2021

Last Updated

January 3, 2023

Record last verified: 2022-12

Locations

TU(1)