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

NCT03457233 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2018-03-07

No results posted yet for this 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

Conditions

  • Invitro Fertilization

Interventions

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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Ahmed Maged · professor

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-03
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03457233 on ClinicalTrials.gov