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临床试验/NCT03484611
NCT03484611Unknown不适用

Prediction of Metaphase II Oocytes According to Different Levels of Serum AMH in Poor Responders Using the Antagonist Protocol

Cairo University1 个研究点 分布在 1 个国家目标入组 179 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
179
试验地点
1
主要终点
Number of the retrieved oocytes

研究概览

简要总结

A multicentric study looked into 179 poor responders who underwent antagonist protocol in ICSI cycles Gonadotrophines is started on day 2 with HMG until the day of HCG administration with starting dose 300IU to 450IU,with no pretreatment with OCPs or progestogens or estrogen.

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 Ovarian ultrasound scans were performed using a 5.0-9.0 MHZ multi frequency trans vaginal probe to assess the ovarian response till the mature follicles reach18-20mm when hCG administration 10000 IU is given to induce final oocytes maturation , serum E2 is done on day of HCG trigger.

Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection.

Ultrasound -guided fresh embryo transfer is performed on day 3 or 5 after fertilization.

Progesterone support of luteal phase was commenced on the day of ovum pick up using prontogest 400 mg twice daily.

详细描述

A multicentric study looked into 179 poor responders who underwent antagonist protocol in ICSI cycles

Induction of ovulation cycle:

  1. Gonadotrophines is started on day 2with HMG(merional, IBSA) ,until the day of HCG administration(choriomon,IBSA10000IU)with starting dose 300IU to 450IU,with no pretreatment with OCPs or progestogens or estrogen.
  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 to induce final oocytes maturation , serum E2 is done on day of HCG trigger.
  4. Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection.
  5. Ultrasound -guided fresh embryo transfer is performed on day 3 or 5 after fertilization. . Embryo transfer was performed under abdominal ultrasound guide for proper embryo placement to the mid-uterine cavity. 0ne to three grade 1 or 2 embryos were transferred on day 3 after oocyte retrieval. The quality of the embryos were graded as 1,2,3 (1 being the best and 3 being the worst) based on the number of cells, degree of fragmentation and regularity. Embryo transfer was performed with a Wallace catheter (Smith Medical International Ltd, Hythe, Kent, UK). Progesterone support of luteal phase was commenced on the day of ovum pick up using prontogest 400 mg twice daily (IBSA, institut Biochemique,Switzerland).

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 3- On antagonist protocol 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 NB: 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

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. 8 . Untreated hyperprolactinemia 9 . Abnormal bleeding disorder
  • 10.Hepatic or renal dysfunction 11.Hypersenstivity to study medication ( GNRH antagonist) 12.Need to take medication that can influence ovarian stimulation 13.Endometriosis grade 3 or 4 14.Ovarian cyst> 10 cm.

研究组 & 干预措施

AMH < 0.3 ng/ml

Active Comparator

Poor ovarian responders according to ESHRE consensus with serum AMH < 0,3 ng/ml

干预措施: GnRH antagonist (Drug)

AMH < 0.3 ng/ml

Active Comparator

Poor ovarian responders according to ESHRE consensus with serum AMH < 0,3 ng/ml

干预措施: Gonadotropins (Drug)

AMH < 0.3 ng/ml

Active Comparator

Poor ovarian responders according to ESHRE consensus with serum AMH < 0,3 ng/ml

干预措施: Human chorionic gonadotropin (Drug)

AMH < 0.3 ng/ml

Active Comparator

Poor ovarian responders according to ESHRE consensus with serum AMH < 0,3 ng/ml

干预措施: Embryo transfer (Procedure)

AMH < 0.3 ng/ml

Active Comparator

Poor ovarian responders according to ESHRE consensus with serum AMH < 0,3 ng/ml

干预措施: Progesterone (Drug)

AMH 0.3 to 0.7 ng/ml

Active Comparator

Poor ovarian responders according to ESHRE consensus with serum AMH 0.3 to 0.7 ng/ml

干预措施: GnRH antagonist (Drug)

AMH 0.3 to 0.7 ng/ml

Active Comparator

Poor ovarian responders according to ESHRE consensus with serum AMH 0.3 to 0.7 ng/ml

干预措施: Gonadotropins (Drug)

AMH > 0.7 to 1 ng/ml

Active Comparator

Poor ovarian responders according to ESHRE consensus with serum AMH 0.7 to 1 ng/ml

干预措施: Gonadotropins (Drug)

AMH 0.3 to 0.7 ng/ml

Active Comparator

Poor ovarian responders according to ESHRE consensus with serum AMH 0.3 to 0.7 ng/ml

干预措施: Human chorionic gonadotropin (Drug)

AMH 0.3 to 0.7 ng/ml

Active Comparator

Poor ovarian responders according to ESHRE consensus with serum AMH 0.3 to 0.7 ng/ml

干预措施: Embryo transfer (Procedure)

AMH 0.3 to 0.7 ng/ml

Active Comparator

Poor ovarian responders according to ESHRE consensus with serum AMH 0.3 to 0.7 ng/ml

干预措施: Progesterone (Drug)

AMH > 0.7 to 1 ng/ml

Active Comparator

Poor ovarian responders according to ESHRE consensus with serum AMH 0.7 to 1 ng/ml

干预措施: GnRH antagonist (Drug)

AMH > 0.7 to 1 ng/ml

Active Comparator

Poor ovarian responders according to ESHRE consensus with serum AMH 0.7 to 1 ng/ml

干预措施: Human chorionic gonadotropin (Drug)

AMH > 0.7 to 1 ng/ml

Active Comparator

Poor ovarian responders according to ESHRE consensus with serum AMH 0.7 to 1 ng/ml

干预措施: Embryo transfer (Procedure)

AMH > 0.7 to 1 ng/ml

Active Comparator

Poor ovarian responders according to ESHRE consensus with serum AMH 0.7 to 1 ng/ml

干预措施: Progesterone (Drug)

结局指标

主要结局

Number of the retrieved oocytes

时间窗: 34 hours after HCG injection

number of oocytes retrieved 34 hours after HCG injection

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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