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临床试验/NCT05405686
NCT05405686撤回4 期

Endometrial Gene Expression Profiles During Ovarian Stimulation With Recombinant FSH With or Without the Addition of Recombinant LH in Genuine Poor Responders

CRG UZ Brussel0 个研究点开始时间: 2023年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
发起方
主要终点
endometrial gene expression

研究概览

简要总结

This is a prospective randomized open-label cross-over study. Poor responder patients will undergo two ovarian stimulation cycles. One with recombinant follicle stimulation hormone (FSH), and an other stimulation with recombinant FSH and recombinant luteinizing hormone (LH). In both groups, a freeze-all strategy will be applied and an endometrial biopsy will be taken 7 days after final oocyte maturation trigger. Endometrial gene expression analysis will be performed on both biopsies. After completion of both treatment cycles, a frozen embryo transfer of a single embryo will be performed.

详细描述

This is a prospective randomized open-label cross-over study, in which patients will be randomized to either start in the control group or in the study group. Participants will undergo both treatments with an interval of minimum 1 and maximum 6 months. In both treatment arms, ovarian stimulation will be started at day 2/3 of the menstrual cycle. In the control group, 225 IU of recombinant FSH will be administered in a fixed antagonist protocol. In the study group, 225 IU of recombinant FSH plus 112,5 IU of recombinant LH will be administered. Cycle monitoring will be performed through serum estradiol (E2), progesterone (P), and luteinizing hormone (LH) assessments, combined with serial ultrasound examinations. Both groups will undergo dual triggering with gonadotropin releasing hormone agonist (GnRHa) 0,2ml and human chorionic gonadotrophin (hCG) 6500IU if one or more follicles of ≥ 17 mm are observed. The oocyte retrieval (OR) will be performed between 34 and 36 hours after final oocyte maturation trigger. At each OR, follicles will be individually meas-ured, aspirated and searched for the presence of cumulus oocyte complexes (COC). Metaphase II (MII) oocytes will then be injected to standard intra-cytoplasmatic sperm injection (ICSI) procedures. In both groups, a freeze-all strategy will be applied. An endometrial biopsy (Pipelle de Cornier ®) will be taken 7 days after final oocyte maturation trigger. After completion of both treatment cycles, a frozen embryo transfer of a single embryo will be performed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
35 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 35-40 years
  • Undergoing IVF/ICSI
  • BMI ≥ 19 and ≤ 30
  • AMH <1.2 ng/mL
  • Previous conventional ovarian stimulation (OS) with < 4 metaphase II (MII) oocytes
  • Regular menstrual cycle (26-35 days)
  • Non-smokers
  • Acceptance to do 2 consecutive ovarian stimulation cycles (between 1-6 months)
  • Signed informed consent

排除标准

  • Endometriosis > rAFS grade II
  • Testicular sperm extraction
  • Recurrent miscarriage (>2 previous miscarriages)
  • Ovarian stimulation for pre-implantation genetic testing (PGT-A/M)
  • Medical/social oocyte vitrification
  • In vitro maturation (IVM)
  • Untreated auto-immune, endocrine or metabolic disorders
  • Asherman's syndrome

研究组 & 干预措施

Control arm

Active Comparator

In the control group, 225 IU of recombinant FSH will be administered in a fixed antagonist protocol.

干预措施: Follitropin alfa (Drug)

Control arm

Active Comparator

In the control group, 225 IU of recombinant FSH will be administered in a fixed antagonist protocol.

干预措施: Endometrial biopsy (Diagnostic Test)

Study arm

Experimental

In the study group, 225 IU of recombinant FSH plus 112,5 IU of recombinant LH will be administered.

干预措施: Lutropin alfa (Drug)

Study arm

Experimental

In the study group, 225 IU of recombinant FSH plus 112,5 IU of recombinant LH will be administered.

干预措施: Follitropin alfa (Drug)

Study arm

Experimental

In the study group, 225 IU of recombinant FSH plus 112,5 IU of recombinant LH will be administered.

干预措施: Endometrial biopsy (Diagnostic Test)

结局指标

主要结局

endometrial gene expression

时间窗: 7 days after finale oocyte maturation trigger

gene expression profile of the endometrium

次要结局

  • implantation rate(6-12 months)
  • live birth rate(20 months)
  • number of preovulatory follicles(3-6 months)
  • cumulus cell gene expression(3-6 months)
  • endometrial histologic analysis based on Noyes' classification system(3-6 months)
  • follicular fluid (FF) hormonal analysis(3-6 months)
  • number of MII oocytes(3-6 months)
  • duration of stimulation(3-6 months)
  • clinical pregnancy rate(6-12 months)
  • progesterone level at oocyte triggering(3-6 months)
  • number of oocytes fertilized(3-6 months)
  • number of good quality embryos(3-6 months)
  • total dose of gonadotropins administered(3-6 months)
  • endometrial thickness at the day of endometrial biopsy(3-6 months)

研究者

发起方
CRG UZ Brussel
申办方类型
Other
责任方
Principal Investigator
主要研究者

Liese Boudry

Principal investigator

CRG UZ Brussel

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