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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03484611
Collaborator
(none)
179
Enrollment
1
Location
3
Arms
62.9
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
179 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Prediction of Metaphase II Oocytes According to Different Levels of Serum AMH in Poor Responders Using the Antagonist Protocol
Actual Study Start Date :
Jan 1, 2013
Anticipated Primary Completion Date :
Apr 1, 2018
Anticipated Study Completion Date :
Apr 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: AMH < 0.3 ng/ml

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

Drug: GnRH antagonist
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
Other Names:
  • cetrorelix

    • Drug: Gonadotropins
    started on day 2 of the menstrual cycle until the day of HCG administration(choriomon,IBSA10000IU)with starting dose 300IU to 450IU
    Other Names:
  • Human menopausal gonadotropin

    • Drug: Human chorionic gonadotropin
    10000 IU is given to induce final oocytes maturation when at least 2 follicles reached 14 mm or more
    Other Names:
  • HCG

    • Procedure: Embryo transfer
    0ne to three grade 1 or 2 embryos were transferred on day 3 after oocyte retrieval. Embryo transfer was performed with a Wallace catheter (Smith Medical International Ltd, Hythe, Kent, UK)

    Drug: Progesterone
    vaginal prontogest 400 mg twice daily
    Active Comparator: AMH 0.3 to 0.7 ng/ml

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

    Drug: GnRH antagonist
    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
    Other Names:
  • cetrorelix

    • Drug: Gonadotropins
    started on day 2 of the menstrual cycle until the day of HCG administration(choriomon,IBSA10000IU)with starting dose 300IU to 450IU
    Other Names:
  • Human menopausal gonadotropin

    • Drug: Human chorionic gonadotropin
    10000 IU is given to induce final oocytes maturation when at least 2 follicles reached 14 mm or more
    Other Names:
  • HCG

    • Procedure: Embryo transfer
    0ne to three grade 1 or 2 embryos were transferred on day 3 after oocyte retrieval. Embryo transfer was performed with a Wallace catheter (Smith Medical International Ltd, Hythe, Kent, UK)

    Drug: Progesterone
    vaginal prontogest 400 mg twice daily
    Active Comparator: AMH > 0.7 to 1 ng/ml

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

    Drug: GnRH antagonist
    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
    Other Names:
  • cetrorelix

    • Drug: Gonadotropins
    started on day 2 of the menstrual cycle until the day of HCG administration(choriomon,IBSA10000IU)with starting dose 300IU to 450IU
    Other Names:
  • Human menopausal gonadotropin

    • Drug: Human chorionic gonadotropin
    10000 IU is given to induce final oocytes maturation when at least 2 follicles reached 14 mm or more
    Other Names:
  • HCG

    • Procedure: Embryo transfer
    0ne to three grade 1 or 2 embryos were transferred on day 3 after oocyte retrieval. Embryo transfer was performed with a Wallace catheter (Smith Medical International Ltd, Hythe, Kent, UK)

    Drug: Progesterone
    vaginal prontogest 400 mg twice daily

    Outcome Measures

    Primary Outcome Measures

    1. Number of the retrieved oocytes [34 hours after HCG injection]

      number of oocytes retrieved 34 hours after HCG injection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    Any factor which may affect reproductive outcome other than that the patient is a poor responder will be excluded from the study, like:

    1. Severe male factor .

    2. Uterine factor (eg: fibroid, polyp, Ashermann, .. etc)

    3. Immunological disorder (eg: SLE, APS, … etc)

    4. Thyroid or adrenal dysfunction

    5. Neoplasia (especially: hypothalamic, pit, ovarian)

    6. Women diagnosed with PCOS according to Rotterdam criteria

    7. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kasr Alainy medical school Cairo Egypt 12111

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Ahmed Maged, MD, professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Maged, professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03484611
    Other Study ID Numbers:
    • 35
    First Posted:
    Apr 2, 2018
    Last Update Posted:
    Apr 2, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Chorionic Gonadotropin
    Cetrorelix
    Menotropins
    Progesterone

    Study Results

    No Results Posted as of Apr 2, 2018