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

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ClinicalTrials.gov Identifier: NCT03457233
Recruitment Status : Unknown
Verified March 2018 by Ahmed Maged, Cairo University.
Recruitment status was:  Recruiting
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

Study Description
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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
Invitro Fertilization Drug: Gonadotropins Drug: GNRH antagonist Drug: Human chorionic gonadotropin Chorimon Drug: Natural progesterone Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 3, 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018
Arms and Interventions
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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 Name: 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 Name: cetrorelix

Drug: Human chorionic gonadotropin Chorimon
10000 IU of HCG are given intramuscular when 2 or more mature follicles reach 18 - 20 mm
Other Name: HCG

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

Drug: Human chorionic gonadotropin Chorimon
10000 IU of HCG are given intramuscular when 2 or more mature follicles reach 18 - 20 mm
Other Name: HCG

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

Drug: Human chorionic gonadotropin Chorimon
10000 IU of HCG are given intramuscular when 2 or more mature follicles reach 18 - 20 mm
Other Name: HCG

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


Outcome Measures
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Primary Outcome Measures :
  1. clinical pregnancy rate [ Time Frame: 4 weeks after HCG triggering ]
    appearance of intrauterine gestational sac by transvaginal ultrasound


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457233


Contacts
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Contact: Ahmed Maged, MD +2001005227404 prof.ahmedmaged@gmail.com
Contact: Radwa Fahmy, MD radwafahmi@yahoo.com

Locations
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Egypt
Kasr Alainy medical school Recruiting
Cairo, Egypt, 12111
Contact: Ahmed Maged, MD    01005227404    prof.ahmedmaged@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged professor
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ahmed Maged, professor, Cairo University
ClinicalTrials.gov Identifier: NCT03457233    
Other Study ID Numbers: 31
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chorionic Gonadotropin
Cetrorelix
Menotropins
Progesterone
Progestins
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Fertility Agents, Female
Fertility Agents
Hormone Antagonists