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The Impact of Body Weight on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03457233
Collaborator
(none)
185
Enrollment
1
Location
3
Arms
37.9
Anticipated Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Gonadotropins
  • Drug: GNRH antagonist
  • Drug: Human chorionic gonadotropin Chorimon
  • Drug: Natural progesterone
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
185 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The Impact of Overweight and Obesity on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles
Actual Study Start Date :
Jan 3, 2015
Anticipated Primary Completion Date :
Mar 1, 2018
Anticipated Study Completion Date :
Mar 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Normal weight

18.5- 24.9 kg/m2

Drug: Gonadotropins
1) Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration
Other Names:
  • Human menopausal gonadotropin

    • Drug: GNRH antagonist
    cetrorelix 0,25mg s.c 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: Human chorionic gonadotropin Chorimon
    10000 IU of HCG are given intramuscular when 2 or more mature follicles reach 18 - 20 mm
    Other Names:
  • HCG

    • Drug: Natural progesterone
    400 mg vaginal tablets twice daily from the day of ovum pick up till HCG tesing
    Other Names:
  • prontogest

    		•
    Active Comparator: Overweight

    BMI 25-29.9 kg/m2

    Drug: Gonadotropins
    1) Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration
    Other Names:
  • Human menopausal gonadotropin

    • Drug: GNRH antagonist
    cetrorelix 0,25mg s.c 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: Human chorionic gonadotropin Chorimon
    10000 IU of HCG are given intramuscular when 2 or more mature follicles reach 18 - 20 mm
    Other Names:
  • HCG

    • Drug: Natural progesterone
    400 mg vaginal tablets twice daily from the day of ovum pick up till HCG tesing
    Other Names:
  • prontogest

    		•
    Active Comparator: Obese

    BMI ≥ 30 kg/m2

    Drug: Gonadotropins
    1) Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration
    Other Names:
  • Human menopausal gonadotropin

    • Drug: GNRH antagonist
    cetrorelix 0,25mg s.c 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: Human chorionic gonadotropin Chorimon
    10000 IU of HCG are given intramuscular when 2 or more mature follicles reach 18 - 20 mm
    Other Names:
  • HCG

    • Drug: Natural progesterone
    400 mg vaginal tablets twice daily from the day of ovum pick up till HCG tesing
    Other Names:
  • prontogest

    		•

    Outcome Measures

    Primary Outcome Measures

    1. clinical pregnancy rate [4 weeks after HCG triggering]

      appearance of intrauterine gestational sac by transvaginal ultrasound

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 44 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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

    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, professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Maged, professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03457233
    Other Study ID Numbers:
    • 31
    First Posted:
    Mar 7, 2018
    Last Update Posted:
    Mar 7, 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 Mar 7, 2018