Comparison of ART Outcomes in Repeat Gonadotrophin-releasing Hormone Agonist Trigger Versus Single Dose Agonist Trigger in PCOS Patients Undergoing IVF/ICSI:A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
All patients , registered in the Department of reproductive medicine, fulfilling inclusion and exclusion criteria undergoing IVF with antagonist protocol will be enrolled in this study after written consent and proper workup as per the protocol of the department.
A written informed consent will be obtained from patients enrolled in the study.
Baseline transvaginal ultrasound will be done(on Mindray DC80 machine frequency of transvaginal probe 7-9MHz) on day2/day3 of cycle.
Controlled ovarian stimulation with gonadotropins is started from day2 or day3 of cycle.
Dose of gonadotropins will depend on age of the patient, antral follicular count, AMH,BMI
GnRH antagonist fixed protocol would be followed ,i.e, GnRH antagonist is started on 6th day of stimulation with gonadotropins.
RANDOMIZATION
Computer-generated randomization sequence using permuted blocks of variable sizes (4, 6, 8) will be employed. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes (SNOSE). Randomization will occur on the day of recruitment.
• Intervention:
• Group A (Single-dose GnRH agonist trigger):
• Triptorelin 0.2 mg subcutaneous injection administered 35 hours before scheduled oocyte retrieval
• Group B (Repeat GnRH agonist trigger)
• Gonadotropins and antagonist are continued until atleast 3 follicles attain a size of greater than equal to17mm following which inj.triptorelin 0.2mg will be administered for final oocyte maturation. Second dose of inj.triptorelin 0.1mg will be administered 12 hours after the first dose .
• As per the protocol practised in the institute, 2 doses of NSAID 12 hours apart is given one day before ovum pickup.
• Ovum pickup will be done 35 hours after the administration of trigger.
• Outcomes would be studied with respect to number and quality of oocytes(M2 oocytes, cleavage stage and blastocyst stage embryos formed and clinical pregnancy rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 38.00 Year(s)(—)
- 性别
- Female
入选标准
- •All women between the age 21-38 years, satisfying diagnostic criteria of PCOS according to ESHRE(2018)criteria which defines: Any 2 of 3 1.Irregular menstrual cycles and anovulation 2.Clinical or biochemical signs of hyperandrogenism 3.Polycystic ovarian morphology after excluding other disorders with similar clinical presentation.
排除标准
- •Other causes of anovulation/irregular menses-Hypothyroid, Hyperprolactinemia, Premature Ovarian Insufficiency Other causes of hyperandrogenemia like late onset Congenital Adrenal Hyperplasia, Cushing’s Syndrome.
研究者
Jhalak Jain
Indira Gandhi Institute of medical sciences
