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临床试验/NCT03457233
NCT03457233Unknown不适用

The Impact of Overweight and Obesity on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles

Cairo University1 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2015年1月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
185
试验地点
1
主要终点
clinical pregnancy rate

研究概览

简要总结

Induction of ovulation cycle:

  1. Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration(choriomon,IBSA10000IU) with starting dose 300 to 450iu.
  2. GNRH antagonist (cetrorelix 0,25mg s.c, cetrotide, serono laboratories, Aubonne Switzerland) is given using flexible protocol, it is given when at least one follicle reaches size 14 mm to prevent premature lutenization ,until the day of hCG administration
  3. Ovarian ultrasound scans were performed using a 5.0-9.0 MHZ multi frequency trans vaginal probe (mindrayDP-5)to assess the ovarian response till the mature follicles reach18-20mm when hCG administration 10000 IU is given.Serum E2 level is done on day of HCG trigger.
  4. Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection
  5. Progesterone vaginal tablets (Prontogest,IBSA) are administrated 400mg twice daily as luteal support from the day of oocytes retrieval.
  6. Ultrasound -guided fresh embryo transfer is performed on day 2 or 3 after fertilization.
  7. Serum hCG assessment to detect pregnancy is performed at 14 days after embryo transfer .if positive(chemical pregnancy) ,women undergo trans -vaginal ultrasonography 2 weeks after, to confirm fetal pulsations as well as number of gestational sacs (clinical pregnancy).
  8. The implantation rate is calculated as the number of viable embryos divided by the number of transferred embryos multiplied by 100

详细描述

Induction of ovulation cycle:

  1. Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration(choriomon,IBSA10000IU) with starting dose 300 to 450iu.
  2. GNRH antagonist (cetrorelix 0,25mg s.c, cetrotide, serono laboratories, Aubonne Switzerland) is given using flexible protocol, it is given when at least one follicle reaches size 14 mm to prevent premature lutenization ,until the day of hCG administration
  3. Ovarian ultrasound scans were performed using a 5.0-9.0 MHZ multi frequency trans vaginal probe (mindrayDP-5)to assess the ovarian response till the mature follicles reach18-20mm when hCG administration 10000 IU is given.Serum E2 level is done on day of HCG trigger.
  4. Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection
  5. Progesterone vaginal tablets (Prontogest,IBSA) are administrated 400mg twice daily as luteal support from the day of oocytes retrieval.
  6. Ultrasound -guided fresh embryo transfer is performed on day 2 or 3 after fertilization.
  7. Serum hCG assessment to detect pregnancy is performed at 14 days after embryo transfer .if positive(chemical pregnancy) ,women undergo trans -vaginal ultrasonography 2 weeks after, to confirm fetal pulsations as well as number of gestational sacs (clinical pregnancy).
  8. The implantation rate is calculated as the number of viable embryos divided by the number of transferred embryos multiplied by 100

研究设计

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

入排标准

年龄范围
20 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 4- Poor responder according to ESHRE consensus; in which at least 2 of the following should be present: Advanced maternal age (≥ 40 years old) or any other risk factor A previous poor ovarian response (cycles cancelled or ≤ 3 oocytes with a conventional protocol)An abnormal ovarian reserve test (ORT); antral follicle count (AFC) < 5-7 follicles or anti-mullerian hormone (AMH) ≤0.5- 1.1 ng/ml In the absence of advanced maternal age or abnormal ORT, two previous episodes of poor ovarian response after maximal stimulation patients are also considered poor responders according to ESHRE consensus.
  • Presence and Adequate visualization of both ovaries Uterine cavity within normal anatomy assessed with HSG, hysteroscopy and TVUS

排除标准

  • Any factor which may affect reproductive outcome other than that the patient is a poor responder will be excluded from the study, like:
  • Severe male factor .
  • Uterine factor (eg: fibroid, polyp, Ashermann, .. etc)
  • Immunological disorder (eg: SLE, APS, ... etc)
  • Thyroid or adrenal dysfunction
  • Neoplasia (especially: hypothalamic, pit, ovarian)
  • Women diagnosed with PCOS according to Rotterdam criteria
  • Hydrosalpinx that hasn't been surgically removed or ligated.
  • Untreated hyperprolactinemia
  • Abnormal bleeding disorder
  • Hepatic or renal dysfunction
  • Hypersenstivity to study medication ( GNRH antagonist)
  • Need to take medication that can influence ovarian stimulation
  • Endometriosis grade 3 or 4
  • Ovarian cyst> 10 cm.

研究组 & 干预措施

Normal weight

Active Comparator

18.5- 24.9 kg/m2

干预措施: Gonadotropins (Drug)

Normal weight

Active Comparator

18.5- 24.9 kg/m2

干预措施: GNRH antagonist (Drug)

Normal weight

Active Comparator

18.5- 24.9 kg/m2

干预措施: Human chorionic gonadotropin Chorimon (Drug)

Normal weight

Active Comparator

18.5- 24.9 kg/m2

干预措施: Natural progesterone (Drug)

Overweight

Active Comparator

BMI 25-29.9 kg/m2

干预措施: Gonadotropins (Drug)

Overweight

Active Comparator

BMI 25-29.9 kg/m2

干预措施: GNRH antagonist (Drug)

Overweight

Active Comparator

BMI 25-29.9 kg/m2

干预措施: Human chorionic gonadotropin Chorimon (Drug)

Overweight

Active Comparator

BMI 25-29.9 kg/m2

干预措施: Natural progesterone (Drug)

Obese

Active Comparator

BMI ≥ 30 kg/m2

干预措施: Gonadotropins (Drug)

Obese

Active Comparator

BMI ≥ 30 kg/m2

干预措施: GNRH antagonist (Drug)

Obese

Active Comparator

BMI ≥ 30 kg/m2

干预措施: Human chorionic gonadotropin Chorimon (Drug)

Obese

Active Comparator

BMI ≥ 30 kg/m2

干预措施: Natural progesterone (Drug)

结局指标

主要结局

clinical pregnancy rate

时间窗: 4 weeks after HCG triggering

appearance of intrauterine gestational sac by transvaginal ultrasound

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Maged

professor

Cairo University

研究点 (1)

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