Invitro Fertilization Clinical Trial
Official title:
The Impact of Overweight and Obesity on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles
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
Status | Recruiting |
Enrollment | 185 |
Est. completion date | March 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 44 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Kasr Alainy medical school | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | clinical pregnancy rate | appearance of intrauterine gestational sac by transvaginal ultrasound | 4 weeks after HCG triggering |
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