Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT07526207
PHASE4

Estradiol 8 vs 12 mg for Endometrial Preparation in HRT-FET

Sponsor: Cairo University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn whether 12 mg or 8 mg of oral estradiol valerate is better for preparing the endometrium in women undergoing hormone replacement frozen embryo transfer (HRT-FET) cycles. It also aims to assess how these two doses affect pregnancy outcomes and cycle success. The main questions it aims to answer are: Does oral estradiol 12 mg/day improve the clinical pregnancy rate compared with 8 mg/day? Do the two doses differ in endometrial thickness, cycle cancellation, miscarriage, and embryo transfer outcomes? Researchers will compare oral estradiol valerate 12 mg/day with oral estradiol valerate 8 mg/day to see whether the higher dose leads to better endometrial preparation and higher clinical pregnancy rates. Participants will: Be randomly assigned to receive either oral estradiol 8 mg/day or 12 mg/day Undergo endometrial preparation before frozen embryo transfer Have endometrial thickness assessed before starting progesterone Undergo embryo transfer and follow-up to assess clinical pregnancy and other outcomes

Official title: Oral Estradiol Dose for Endometrial Preparation in Hormone Replacement Frozen Embryo Transfer Cycles: A Randomized Comparative Clinical Trial Comparing 8 mg and 12 mg on Clinical Pregnancy Rate

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

850

Start Date

2022-05-01

Completion Date

2026-04-01

Last Updated

2026-04-13

Healthy Volunteers

No

Interventions

DRUG

Progynova®

Oral estradiol valerate 8 mg/day Oral estradiol valerate administered as 2 mg tablets for a total daily dose of 8 mg (four active tablets daily), starting on cycle day 2 for endometrial preparation in programmed HRT frozen embryo transfer cycles. Endometrial thickness was reassessed after 10 days; if the endometrium remained \<7 mm, treatment could be continued for an additional 3 to 5 days. After adequate endometrial preparation, progesterone was initiated, and estradiol was continued through embryo transfer and until 12 completed weeks of gestation if pregnancy was confirmed.

DRUG

Progynova®

Oral estradiol valerate 12 mg/day Oral estradiol valerate administered as 2 mg tablets for a total daily dose of 12 mg (six active tablets daily), starting on cycle day 2 for endometrial preparation in programmed HRT frozen embryo transfer cycles. Endometrial thickness was reassessed after 10 days; if the endometrium remained \<7 mm, treatment could be continued for an additional 3 to 5 days. After adequate endometrial preparation, progesterone was initiated, and estradiol was continued through embryo transfer and until 12 completed weeks of gestation if pregnancy was confirmed.

Locations (1)

Cairo University

Cairo, Al-Manial, Egypt