Safety and Efficacy of Transdermal Estrogen (Gel) Versus Oral Estrogen for Endometrial Preparation in Down-regulated Frozen Embryo Transfer (FET) Cycles-An Open-label Multi Centric Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Endometrial thickness (ET)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
All cases undergoing frozen embryo transfer with own or donor gametes.
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile patients aged 23-35 years.
- •BMI 18.5 to 29.9 kg/m
- •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).
排除标准
- •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.
研究组 & 干预措施
Transdermal Gel
In the Estradiol gel group patients will be administered transdermal Estradiol gel (17-beta Estradiol gel 0.06%)
干预措施: 17-beta Estradiol gel 0.06% w/w(ESTOGEL.Intas pharma) (Drug)
Oral Estradiol
In the Oral Estradiol group, all women will be given oral Estradiol valerate tablets
干预措施: Estradiol Hemihydrate(Estrabet Tablet, abbott pharma) (Drug)
结局指标
主要结局
Endometrial thickness (ET)
时间窗: 14 to 21 days after start of estrogen
Average endometrial thickness achieved on day 14 of HRT
次要结局
- Cycle cancelation rate(21 days after starting HRT)
- Average E2 consumption(On 1 day of embryo transfer)
- Implantation rates (IR)(4 weeks + 2 weeks after embryo transfer)
- Clinical pregnancy rates (CPR)(4 weeks + 2 weeks after embryo transfer)
- Miscarriage rates (MR)(Within 20 weeks of gestation)
- Patient satisfaction score(on 1 day of embryo transfer)
研究者
Dr Vipin Chandra
Chief Clinical Lab Operations
Indira IVF Hospital Pvt Ltd