NCT05825885

Brief Summary

This prospective controlled study aimed to investigate the effect of the duration of estrogen (E2) administration prior to progesterone (P) initiation on live birth rates (LBR) in frozen embryo transfer (FET) cycles. The study was conducted at a single tertiary-care in vitro fertilization (IVF) center and included 486 patients undergoing high-quality frozen blastocyst transfer in a hormone replacement therapy (HRT) cycle. Patients scheduled for E2 therapy were administered either 5-7, 8-10, or 11-13 days of treatment, depending on their presentation day. After the E2-only phase, if the endometrial thickness was above 7mm, P was initiated (daily 300mg of vaginal micronized P tablets), and FET was performed on the 6th day of P treatment. The primary outcome measure was LBR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
420

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

April 11, 2023

Last Update Submit

February 25, 2025

Conditions

Keywords

Endometrial compactionEndometrial receptivityEndometrial thicknessFrozen embryo transferHRTPregnancy

Outcome Measures

Primary Outcomes (1)

  • live birth rate

    the birth ratio of a baby who showed any sign of life

    2 years

Secondary Outcomes (3)

  • implantation rate

    2 years

  • clinical pregnancy rate

    2 years

  • miscarriage rate

    2 years

Study Arms (3)

5-7 days E2 therapy

Patient group treated with e2 for 5-7 days

8-10 days E2 therapy

Patient group treated with e2 for 5-7 days

11-13 days E2 therapy

Patient group treated with e2 for 5-7 days

Interventions

E2DRUG

micronized E2 at a daily dose of 4-6mg,

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All patients who have artificial endometrial preparation with high-quality blastocysts between January 2020 and December 2021 were included.

You may qualify if:

  • Exogenous hormone preparation of the endometrial lining
  • High embryo quality ((≥2BB) according to Alpha criteria
  • Embryo transfer at the blastocyst stage

You may not qualify if:

  • \- Patients whose treatments were canceled for any reason before the embryo transfer procedure
  • Patients who underwent embryo transfer in the cleavage stage
  • Presence of low-quality (\<2BB) blastocysts
  • \>15% loss of viability of the embryo during embryo thawing,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Antalya, 07700, Turkey (Türkiye)

Location

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

April 11, 2023

First Posted

April 24, 2023

Study Start

January 1, 2020

Primary Completion

December 31, 2021

Study Completion

May 1, 2023

Last Updated

February 27, 2025

Record last verified: 2025-02

Locations