NCT04114500

Brief Summary

The outcomes of frozen embryo transfer (FET) have substantially improved over the last decade, due to the improvements in the cryopreservation process, Artificial endometrial preparation is typically accomplished by the administration of estradiol (E2) supplementation and exogenous progesterone (P) in order to transform the endometrium into a secretory one, mimicking a natural cycle , The current study aims to determine the association, if any, between serum E2 and P levels, measured same day of FET, and pregnancy outcome

Trial Health

87
On Track

Trial Health Score

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

Enrollment
402

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

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

April 3, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

September 22, 2019

Last Update Submit

July 7, 2020

Conditions

Keywords

EstradiolFETIVFProgesterone

Outcome Measures

Primary Outcomes (2)

  • Pregnancy rate

    B-hCG

    2 weeks

  • clinical pregnancy rate

    positive fetal heart beat

    4 weeks

Interventions

blood sample for measuring serum estradiol and progesterone level on the same day of FET

Eligibility Criteria

Age22 Years - 40 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients undergoing IVF/FET were recruited from April 2018 to September 2019.

You may qualify if:

  • patients who underwent frozen-thawed embryos transfer treatment
  • the endometrial preparation was initiated with oral estradiol valerate
  • the endometrial thickness was no less than 8 mm on the day when P was administrated;
  • normal endometrial ultrasound imaging
  • euploid pre-genetically tested embryos

You may not qualify if:

  • age\> 40 years
  • BMI \> 35
  • abnormal ultrasonogram of uterine cavity
  • abnormal embryos not suitable for transfer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-BARAKA FERTILITY HOSPITAL

Manama, Adliya, 15006, Bahrain

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor , medical director

Study Record Dates

First Submitted

September 22, 2019

First Posted

October 3, 2019

Study Start

April 3, 2018

Primary Completion

May 1, 2019

Study Completion

May 5, 2019

Last Updated

July 8, 2020

Record last verified: 2020-07

Locations