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Trial record 21 of 80 for:    ASNS

Poor Ovarian Stimulation Response in In Vitro Fertilization (IVF) Program

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ClinicalTrials.gov Identifier: NCT02640976
Recruitment Status : Completed
First Posted : December 29, 2015
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
Nadine wagdi maurice, Cairo University

Brief Summary:
The aim of this study is to assess the role of AMH in prediction of poor ovarian response as well as the relation between ESR2 (+1730G>A) (rs4986938), FSHR p.Thr307Ala (c.919A>G, rs6165) and FSHR p.Asn680Ser (c.2039A>G, rs6166) SNPs and the poor response in Egyptian women undergoing IVF procedure. Discovering the genetic variants associated with ovarian response is an important step towards individualized pharmacogenetic protocols of ovarian stimulation.

Condition or disease Intervention/treatment Phase
Infertility Drug: Human menopausal gonadotrophin (HMG) Drug: GnRH antagonist Cetrorelix Drug: Human chorionic gonadotrophin (hCG) Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Assessing the Relation Between Hormone Receptors Gene Polymorphism and Ovarian Stimulation Response in In Vitro Fertilization (IVF) Program
Study Start Date : June 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Poor responders

This group will include women who underwent IVF/ICSI cycle and produced 4 oocytes or less.

intervention:

  1. fixed daily morning dose of Human menopausal gonadotrophin (HMG) Merional® intra-muscular injection ,starting on cycle day 2 and will be maintained for 9-11 days according to each individual ovarian response,at a dose of (300 IU).
  2. On cycle day 7, the GnRH antagonist Cetrorelix 0.25 mg Cetrotide® will be introduced as daily subcutaneous injections and continued till the day of ovulation triggering.
  3. Finally, when at least 3 follicles will reach 17 mm in diameter, ovulation will be triggered by a single intra-muscular injection of 10,000 IU of Human chorionic gonadotrophin (hCG) Choriomon®.
Drug: Human menopausal gonadotrophin (HMG)
[Merional® 75 IU ampoules, IBSA institut]
Other Name: Merional®

Drug: GnRH antagonist Cetrorelix
[Cetrotide® 0.25 mg syringes, Merck Serono]
Other Name: Cetrotide®

Drug: Human chorionic gonadotrophin (hCG)
[Choriomon® 5000 IU ampoules, IBSA institut]
Other Name: Choriomon®

Active Comparator: Good responders

This group will include women who produced (5 or more oocytes) after COH.

Intervention:

  1. fixed daily morning dose of Human menopausal gonadotrophin (HMG) Merional® intra-muscular injection ,starting on cycle day 2 and will be maintained for 9-11 days according to each individual ovarian response,at a dose of (225 IU) for participants with AMH levels > 1.5 ng/ml and/or FSH levels ≤ 8 mIU/ml
  2. On cycle day 7, the GnRH antagonist Cetrorelix 0.25 mg Cetrotide® will be introduced as daily subcutaneous injections and continued till the day of ovulation triggering.
  3. When at least 3 follicles will reach 17 mm in diameter, ovulation will be triggered by a single intra-muscular injection of 10,000 IU of Human chorionic gonadotrophin (hCG) Choriomon®.
Drug: Human menopausal gonadotrophin (HMG)
[Merional® 75 IU ampoules, IBSA institut]
Other Name: Merional®

Drug: GnRH antagonist Cetrorelix
[Cetrotide® 0.25 mg syringes, Merck Serono]
Other Name: Cetrotide®

Drug: Human chorionic gonadotrophin (hCG)
[Choriomon® 5000 IU ampoules, IBSA institut]
Other Name: Choriomon®




Primary Outcome Measures :
  1. number of oocytes collected [ Time Frame: 3 weeks from of start of ICSI cycle ]
    when at least 3 follicles will reach 17 mm in diameter, ovulation will be triggered by a single intra-muscular injection of 10,000 IU of hCG [Choriomon® 5000 IU ampoules, IBSA institut]. 36 hours later, oocyte retrieval will be performed and will be guided by transvaginal ultrasound.


Secondary Outcome Measures :
  1. Detection of the single nucleotide polymorphisms ESR2(+1730G>A) (rs4986938), FSHR p.Thr307Ala (c.919A>G, rs6165) and FSHR p.Asn680Ser (c.2039A>G, rs6166) SNPs will be performed using the TaqMan system by real-time polymerase chain reaction (PCR) [ Time Frame: Within 1 week ]
    By using PCR, we will indicate the genotype in each individual and determine the probability of the poor ovarian response.


Other Outcome Measures:
  1. Laboratory analysis of basal follicle stimulating hormone level for each individual will be measured by enzyme-linked immunosorbent assay (ELISA) [ Time Frame: Done within 3 months preceeding the ICSI cycle ]
    Based on FSH level, the dose of HMG ( Merional) will be adjusted for each individual.

  2. Laboratory analysis of anti-mullerian hormone level (AMH) will be measured by ELISA technique for each individual. [ Time Frame: Done within 3 months preceeding the ICSI cycle. ]
    Based on AMH level, the dose of HMG (Merional) will be adjusted for each individual.



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Ages Eligible for Study:   25 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women at or under the age of 35 years.
  • Normal thyroid stimulating hormone and prolactin levels.
  • Normal ovulatory cycles (25-35 interval days), together with proven patent fallopian tubes at hysterosalpingography or laparoscopy done within six cycles preceding the ICSI cycle.
  • Presence of both ovaries with normal findings as assessed by trans-vaginal ultrasound and laparoscopy.
  • All male partners had a normal semen analysis according to WHO criteria (WHO, 2010), done within 6 months preceding the ICSI cycle

Exclusion Criteria

  • Chronic medical disorders such as diabetes.
  • Previous inadequate response to ovulation induction.
  • Polycystic ovary syndrome.
  • Women who performed ovarian surgery and cases of endometriosis diagnosed by laparoscopy or suspected by ultrasound or CA-125 assay.
  • Abnormal pelvic pathology or congenital anomalies.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nadine wagdi maurice, Demonstrator at faculty of pharmacy Cairo university biochemistry department, Cairo University
ClinicalTrials.gov Identifier: NCT02640976     History of Changes
Other Study ID Numbers: BC (705)
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Nadine wagdi maurice, Cairo University:
in vitro fertilization
controlled ovarian hyperstimulation
poor ovarian response
estrogen receptor 2 gene polymorphism
follicle stimulating hormone receptor gene polymorphism
anti-mullerian hormone
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Cetrorelix
Menotropins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Fertility Agents, Female
Fertility Agents
Hormone Antagonists