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Status unknownNCT03457233Updated Mar 7, 2018

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

An interventional study of Gonadotropins and GNRH antagonist in Invitro Fertilization, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 44 Years. Per ClinicalTrials.gov, last updated 2018-03-07.

Sponsored by Cairo University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
185
Allocation
Non-randomized
Ages
20 Years to 44 Years
Sex
Female
01

Study 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
Read the 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
02

Conditions studied

  • Invitro Fertilization
03

Who can participate

Ages eligible
20 Years to 44 Years
Sexes eligible
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

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.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
185 participants (estimated)

Study arms

  • Active comparator
    Normal weight

    18.5- 24.9 kg/m2

    Drug: Gonadotropins · Drug: GNRH antagonist · Drug: Human chorionic gonadotropin Chorimon · Drug: Natural progesterone

  • Active comparator
    Overweight

    BMI 25-29.9 kg/m2

    Drug: Gonadotropins · Drug: GNRH antagonist · Drug: Human chorionic gonadotropin Chorimon · Drug: Natural progesterone

  • Active comparator
    Obese

    BMI ≥ 30 kg/m2

    Drug: Gonadotropins · Drug: GNRH antagonist · Drug: Human chorionic gonadotropin Chorimon · Drug: Natural progesterone

Interventions

  • DrugGonadotropins

    1) Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration

    Also known as: Human menopausal gonadotropin

  • DrugGNRH 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

    Also known as: cetrorelix

  • DrugHuman chorionic gonadotropin Chorimon

    10000 IU of HCG are given intramuscular when 2 or more mature follicles reach 18 - 20 mm

    Also known as: HCG

  • DrugNatural progesterone

    400 mg vaginal tablets twice daily from the day of ovum pick up till HCG tesing

    Also known as: prontogest

05

What researchers measure

Primary outcomes

  1. clinical pregnancy rate

    appearance of intrauterine gestational sac by transvaginal ultrasound

    Time frame: 4 weeks after HCG triggering

06

Study locations

1 of 1 sites recruiting
  • Kasr Alainy medical school
    Cairo, 12111, Egypt
    Recruiting
07

References and documents

Publications

  • Maged AM, Fahmy RM, Rashwan H, Mahmood M, Hassan SM, Nabil H, Hany A, Lotfy R, Lasheen YS, Dahab S, Darwish M. Effect of body mass index on the outcome of IVF cycles among patients with poor ovarian response. Int J Gynaecol Obstet. 2019 Feb;144(2):161-166. doi: 10.1002/ijgo.12706. Epub 2018 Nov 26. PubMed 30407618 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03457233
Lead sponsor
Cairo University
Responsible party
Ahmed Maged (professor, Cairo University) — Principal investigator
First posted
Mar 7, 2018
Start date
Jan 3, 2015
Primary completion
Mar 2018 (estimated)
Completion
Mar 2018 (estimated)
Last update
Mar 7, 2018

Study contacts

Ahmed Maged, MD
Contact
prof.ahmedmaged@gmail.com
+2001005227404
Radwa Fahmy, MD
Contact
radwafahmi@yahoo.com
Ahmed Maged
principal investigator · professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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