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CompletedNCT05825885Updated Feb 27, 2025

The Impact of Estrogen Administration Duration in Hormonally Prepared Frozen Embryo Transfer Cycles

An observational study in Duration of Estrogen Administration, sponsored by Akdeniz University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-02-27.

Sponsored by Akdeniz University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
420
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the detailed description

The timing of P initiation in HRT cycles depends on the thickness and morphology of the endometrium, which are influenced by the duration of E2 treatment. Although numerous studies have examined the effect of E2 treatment duration on endometrial thickness and morphology, the results have been inconsistent, and the impact on live birth rates (LBR) remains unclear. Previous research has explored the impact of standard 12-day E2 therapy and prolonged periods of E2 administration on pregnancy outcomes. However, the present study aims to compare the effects of standard 12-day E2 therapy with shorter-term E2 application and evaluate their impact on treatment outcomes.

To test hypothesis, investigators conducted a prospective analysis of about 500 hormonally prepared frozen embryo transfer (FET) cycles performed between January 2020 and December 2021 at IVF center in Akdeniz University. The objective of this study was to determine the optimal duration of estrogen (E2) therapy prior to progesterone (P) initiation for FET cycles in terms of live birth rate (LBR).

In IVF center, patients with frozen embryos routinely applied to the center on weekdays (Monday, Wednesday, and Friday) as part of a predetermined treatment plan. Patients who presented to the clinic during their menstrual periods were scheduled to receive E2 therapy for a duration of either 5-7, 8-10, or 11-13 days, depending on the day they presented. After the application of micronized E2 at a daily dose of 4-6mg, transvaginal ultrasonography was performed to assess endometrial thickness. If the endometrial thickness was found to be above 7mm, daily 300mg of vaginal micronized P tablets were initiated, and FET was performed on the 6th day of P treatment. Patients whose endometrial thickness was less than 7 millimeters on transvaginal ultrasonography after the application of E2 treatment for the specified day and who had to continue estrogen therapy were not included in the study.

The duration of E2 administration prior to P initiation was categorized into three groups: 5-7 days, 8-10 days, and 11-13 days. The primary outcome of this study was LBR, which was defined as the delivery of a live-born infant after 24 weeks of gestation. Secondary outcomes included implantation rate, clinical pregnancy rate, and miscarriage rate.

02

Conditions studied

  • Duration of Estrogen Administration

Keywords

  • Endometrial compaction
  • Endometrial receptivity
  • Endometrial thickness
  • Frozen embryo transfer
  • HRT
  • Pregnancy
03

In context

Lead sponsor

Akdeniz University is the lead sponsor of 296 studies on the registry; 62 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • - 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,
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
420 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DrugE2

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

06

What researchers measure

Primary outcomes

  1. live birth rate

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

    Time frame: 2 years

Secondary outcomes

  1. implantation rate

    the percentage of embryos which successfully undergo implantation compared to the number of embryos transferred in a given period.

    Time frame: 2 years

  2. clinical pregnancy rate

    the number of clinical pregnancy divided by the number of embryo transfer cycle for each group

    Time frame: 2 years

  3. miscarriage rate

    rate of the spontaneous loss of a pregnancy before the 20th week

    Time frame: 2 years

07

Study locations

1 site
  • Akdeniz University
    Antalya, Antalya 07700, Turkey (Türkiye)
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05825885
Lead sponsor
Akdeniz University
Responsible party
ŞAFAK OLGAN (Associate Professor, Akdeniz University) — Principal investigator
First posted
Apr 24, 2023
Start date
Jan 1, 2020
Primary completion
Dec 31, 2021
Completion
May 1, 2023
Last update
Feb 27, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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