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Clinical Trials/CTRI/2025/04/084727
CTRI/2025/04/084727Not yet recruitingNot Applicable

A retrospective investigator-initiated study to observe the effectiveness and safety of estradiolhemihydrate tablet usage vaginally in patients with thin endometrial for endometrial preparation inFrozen Embryo Transfer (FET) cycles

Dr Jatin Shah1 site in 1 country80 target enrollmentStarted: April 25, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
A retrospective real world observational study to observe the effectiveness and safety of estradiol

Study Overview

Brief Summary

This is a retrospective real world observational study to observe the effectiveness and safety of estradiol hemihydrate tablet usage vaginally in patients with thin endometrial for artificial endometrial preparation in Frozen Embryo Transfer (FET) cycles

Study Design

Study Type
Observational

Eligibility Criteria

Ages
25.00 Year(s) to 42.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Age 25 to 42 years (both inclusive) b.
  • Patients planned to undergo Frozen embryo transfer cycle where endometrial preparation will be done by hormone replacement therapy (HRT) c.
  • Normal pelvic ultrasonography.

Exclusion Criteria

  • Women who smoke b.
  • Women under 25 years or over 42 years of age c.
  • Women who had unexplained vaginal bleeding d.
  • Women who had Ashermans syndrome e.
  • Women with history of Malignancy, HIV and Tubercular endometritis g.
  • Any Contraindications for receiving estradiol h.
  • Hypersensitivity to estradiol or any of its excipients i.

Outcomes

Primary Outcomes

A retrospective real world observational study to observe the effectiveness and safety of estradiol

Time Frame: Following retrospective data will be collected in this study. | • Patients Age | • Duration and cause of Infertility | • Number of previous IVF treatment cycle | • Base line investigations | • Endometrial thickness - before starting and after administration of vaginal estradiol | hemihydrate; and on progesterone start day | • Pregnancy test - positive or negative 10 to 15 days after embryo

hemihydrate tablet usage vaginally in patients with thin endometrial for artificial endometrial

Time Frame: Following retrospective data will be collected in this study. | • Patients Age | • Duration and cause of Infertility | • Number of previous IVF treatment cycle | • Base line investigations | • Endometrial thickness - before starting and after administration of vaginal estradiol | hemihydrate; and on progesterone start day | • Pregnancy test - positive or negative 10 to 15 days after embryo

preparation in Frozen Embryo Transfer (FET) cycles

Time Frame: Following retrospective data will be collected in this study. | • Patients Age | • Duration and cause of Infertility | • Number of previous IVF treatment cycle | • Base line investigations | • Endometrial thickness - before starting and after administration of vaginal estradiol | hemihydrate; and on progesterone start day | • Pregnancy test - positive or negative 10 to 15 days after embryo

Secondary Outcomes

  • NA(NA)

Investigators

Sponsor
Dr Jatin Shah
Sponsor Class
Research institution and hospital

Study Sites (1)

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