Frozen Embryo Transfer, Infertility, Female
Conditions
Keywords
Transdermal Estrogen, FET, Oral Estrogen, IVF/ICSI
Brief summary
The goal of this randomized study trial is to comparing transdermal estradiol gel and oral estradiol for endometrial preparation in the Frozen Embryo Transfer Cycle. The main question\[s\] it aims to answer is: • Can Transdermal estrogen (gel) can be equally efficacious as compared to oral estrogen in hormone replacement FET (HRT- FET) cycles ? The Transdermal gel would have the added benefit of a higher patient comfort with fewer side effects and a better safety profile. Participants planned for Frozen embryo transfer will undergo H-P-O axis suppression on previous cycle D21 of menses with gonadotropin-releasing hormone(GnRH) agonist depot preparation (Inj. Decapeptyl 3.75 mg) IM . The study will compare Transdermal E2 gel with Oral E2 tabs. The patients will be randomized into an oral and gel group, and all patients will participate only once in the study.
Detailed description
Estrogen priming is essential for the induction of progesterone receptors and to build endometrial thickness, both of which play an important role in regulating endometrial receptivity . Different routes of Estrogen administration are oral (tablets), transdermal (patch/gel), and vaginal (tablets).
Interventions
DRUG17-beta Estradiol gel 0.06% w/w(ESTOGEL.Intas pharma)
In the Estradiol gel group patients will be administered transdermal Estradiol gel (17-beta Estradiol gel 0.06% w/w) 2 puffs thrice a day (each application contains 1.25 mg with 0.75 mg of the drug).
DRUGEstradiol Hemihydrate(Estrabet Tablet, abbott pharma)
In the oral Estradiol group, all women will be given 2 mg of Estradiol valerate tablets, one tablets thrice a day within 30 days of injection triptorelin depot. Endometrial assessment will be performed on D10 of HRT. Please see the flow diagram (in the annexure) for details.
Sponsors
Indira IVF Hospital Pvt Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
All cases undergoing frozen embryo transfer with own or donor gametes.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Infertile patients aged 23-35 years. * BMI 18.5 to 29.9 kg/m2. * A normal uterine cavity assessed by 3D ultrasound (USG)/hysteroscopy. * Patients who underwent IVF/ICSI and who have cryopreserved their embryos. * Those receiving donor oocytes or donor embryos. * Patients undergoing hormonal replacement frozen embryo transfer (HRT-FET) cycles with GnRH agonist suppression. * Embryo Transfers of good quality embryos -2/3/4/5 AA, AB, BA(As per Gardner Grading System).
Exclusion criteria
* Preimplantation Genetic Testing for Aneuploidies (PGT-A) cycles. * Patients who had a FET performed in natural or stimulated cycles. * Patients who had more than 2 failed transfers due to thin endometrium. * Patients having uterine anomalies. * Known cases of adenomyosis and endometriosis. * Underlying cardiac/renal/hepatic/thromboembolic disorders, h/o anxiety or depression. * E2 \>50 pg./ml, P4 \> 1 ng/ml and on D2 of menses. * On D2 scan presence of a cyst or a dominant follicle. * Patients with a history of recurrent 1st-trimester abortions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endometrial thickness (ET) | 14 to 21 days after start of estrogen | Average endometrial thickness achieved on day 14 of HRT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cycle cancelation rate | 21 days after starting HRT | Number of cycles cancelled before embryo transfer × 100 |
| Average E2 consumption | On 1 day of embryo transfer | Total E2 consumed till embryo transfer |
| Implantation rates (IR) | 4 weeks + 2 weeks after embryo transfer | The number of gestational sacs observed by transvaginal ultrasound at the 6th gestational week per the number of embryos transferred. |
| Miscarriage rates (MR) | Within 20 weeks of gestation | Number of spontaneous pregnancy losses in which a gestational sac was previously observed (before gestation week \<20 weeks) per 100 clinical pregnancy . |
| Patient satisfaction score | on 1 day of embryo transfer | It is measured using visual analogue scale(VAS) score |
| Clinical pregnancy rates (CPR) | 4 weeks + 2 weeks after embryo transfer | Detection of a foetal heartbeat on transvaginal ultrasound at the 6th gestational week per embryo transfer cycle |
Other
| Measure | Time frame | Description |
|---|---|---|
| Undesirable side effects between both the groups | Till 12 weeks of pregnancy | Symptoms like rash, itching ,burning, thromboembolic event |
Countries
India
Outcome results
None listed