NCT03457233

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

The Impact of Overweight and Obesity on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 185 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 20 Years – 44 Years
• Healthy volunteers: Not accepted

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

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

Conditions

• Invitro Fertilization

Interventions

Type	Name	Description
DRUG	Gonadotropins	1\) Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration
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
DRUG	Human chorionic gonadotropin Chorimon	10000 IU of HCG are given intramuscular when 2 or more mature follicles reach 18 - 20 mm
DRUG	Natural progesterone	400 mg vaginal tablets twice daily from the day of ovum pick up till HCG tesing

Timeline

• Start date: 2015-01-03
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2018-03-07
• Last updated: 2018-03-07

Locations

1 site across 1 country: Egypt