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

Not yet recruiting

• Conditions: Pregnancy, childbirth and the puerperium,

• Registration Number: CTRI/2025/04/084727
• Lead Sponsor: Dr Jatin Shah

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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-14
• Study Start: 2025-04-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A retrospective real world observational study to observe the effectiveness and safety of estradiol	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	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	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 Outcome Measures

Name	Time	Method
NA	NA

Trial Locations

Locations (1)

Kamala Poly Clinic & Nursing Home; 🇮🇳 Mumbai, MAHARASHTRA, India

Kamala Poly Clinic & Nursing Home

🇮🇳Mumbai, MAHARASHTRA, India

Dr Jatin Shah

Principal investigator

9820080449

drjatin2000@gmail.com