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临床试验/NCT06769789
NCT06769789尚未招募不适用

Evaluation of Pregnancy Outcome in Poor Responder Patients in IVF Cycle with Usage of Drug-free In-vitro Activation of Follicles Ovary

Malihe Mahmoudinia0 个研究点目标入组 23 人开始时间: 2025年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
23
主要终点
Number of embryos

研究概览

简要总结

This study is the pilot study to evaluate the effect of Drug-free in vitro activation to improve the outcomes of IVF in poor responder women

详细描述

First, patients who are poor responders based on Poseidon criteria 1, 3 (women under 35 years of age who either have abnormal ovarian reserve tests or have not had an adequate ovarian response in an IVF cycle) are included in the list of poor responders and are consulted after a complete evaluation by a physician. The patient has a history of poor response in previous IVF cycles. After obtaining the patient's consent, the patient undergoes laparoscopy. The laparoscopy procedure will be performed at Milad Infertility Center, which is equipped with a laparoscopy operating room and a laboratory nearby. The procedures will be performed by a single surgical team that includes laparoscopy and infertility flowsheets. After general anesthesia and pre- and post-operative care, double puncture laparoscopy will be performed. Two minor trocars will be placed, which will be held in place by an ovarian grasper. With scissors, a part of the ovarian cortex is first separated from the underlying medulla and strips of cortex 1 to 2 mm thick and 10 mm long are removed. They are immediately transferred to the adjacent laboratory. A 1 x 5 mm sample from the removed piece is used for histological examination and determination of the number of remaining follicles. The tissue is then divided into 1 x 1 x 1 mm pieces. The removal site will be sutured in case of bleeding. The preparation of the ovary into small pieces will be performed by a single physician for all patients. The prepared pieces are immediately transferred to the operating room. Then the surgeon places the prepared pieces in the tunnel between the cortex and medulla in the opposite ovary and then sutured. The patient is then followed up and immediately treated with FSH (Sinagene Company, Tehran, Iran) at a maximum dose of 300 units, and then the dose is adjusted according to the ovarian response. When a 12 mm follicle is observed, 0.25 mg of Sterotide (Merck Serono, Mississauga, Canada) is started. When the size of 1 or 2 follicles reaches 16, 10,000 units of HCG (Puyish Daru Company, Tehran, Iran) and two ampoules of Deca (Decapeptyl 0.2 mg, Ferring, Germany) are given together for triggering. Ovulation is performed 36 hours later under transvaginal ultrasound guidance.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Women under 35 years of age who have one of the following characteristics:
  • •Or poor response to gonadotropins in a previous IVF cycle (fewer than 3 oocytes in a previous IVF cycle)
  • •Or ovarian reserve test AMH less than 1.1

排除标准

  • •Unwillingness to continue working with the researcher during the procedure

研究组 & 干预措施

Experimental: Drug -free invitro activation of ovary in women

Experimental

干预措施: Drug free invitro activation Ovary (Other)

结局指标

主要结局

Number of embryos

时间窗: Within 3 weeks after ovarian stimulation

The number of oocytes obtained at oocyte pick-up (OPU)

时间窗: Within 3 weeks after ovarian stimulation

Quality of embryos at the end of IVF treatment

时间窗: Within 3 weeks after ovarian stimulation

A grade embryo was defined to have four blastomeres on the second day and seven or eight blastomeres on the third day with equal size and \<20% fragmentation (high quality). Blastocyst embryos were assessed according to Gardner's criteria.

次要结局

  • Implantation rate(4-8 weeks after transfer)
  • Clinical pregnancy rate(one month after transfer)
  • Miscarriage rate(20 weeks after transfer)

研究者

发起方
Malihe Mahmoudinia
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Malihe Mahmoudinia

Associate Professor of obstetrics & Gynecology, Fellowship of infertility, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

Mashhad University of Medical Sciences

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