Estradiol 8 vs 12 mg for Endometrial Preparation in HRT-FET (NCT07526207) | Clinical Trial Compass
CompletedPhase 4
Estradiol 8 vs 12 mg for Endometrial Preparation in HRT-FET
Egypt850 participantsStarted 2022-05-01
Plain-language 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
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* Inclusion Criteria
* Women aged 18 to 40 years
* Body mass index (BMI) less than 30 kg/m²
* Undergoing assisted reproduction treatment at the IVF Unit of Kasr Al-Ainy Teaching Hospital
* Scheduled for an autologous programmed hormone replacement frozen embryo transfer (HRT-FET) cycle
* Endometrial preparation planned using oral estradiol valerate only
* Embryos obtained from a previous IVF or ICSI cycle
* Planned transfer of vitrified-warmed day-5 blastocyst embryo(s)
* First frozen embryo transfer cycle
* Normal uterine cavity confirmed within the previous 12 months
* Baseline transvaginal ultrasound showing no ovarian cyst, dominant follicle, or uterine cavity abnormality
* Willing and able to provide informed consent
* Exclusion Criteria
* Contraindication to estrogen treatment
* History of breast cancer or endometrial cancer
* History of deep venous thrombosis, pulmonary embolism, or stroke
* Allergy to the study medication
* Irregular vaginal bleeding
* Thyroid disorder
* Hyperprolactinemia
* Uncontrolled diabetes mellitus
* Uncontrolled hypertension
* Significant liver disease
* Significant kidney disease
* Severe systemic illness
* Uterine abnormality
* Untreated hydrosalpinx
* Untreated pathology inside the uterine cavity
* Donor-oocyte cycle
* Donor-embryo cycle
* Gestational-carrier cycle
* Preimplantation genetic testing for aneuploidy (PGT-A) cycle
* Natural cycle or modified natural cycle for endom…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.