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

Not Applicable

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

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

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

Recruitment & 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:

Arm && Interventions

Group	Intervention	Description
Normal weight	GNRH antagonist	18.5- 24.9 kg/m2
Overweight	GNRH antagonist	BMI 25-29.9 kg/m2
Overweight	Gonadotropins	BMI 25-29.9 kg/m2
Overweight	Human chorionic gonadotropin Chorimon	BMI 25-29.9 kg/m2
Overweight	Natural progesterone	BMI 25-29.9 kg/m2
Normal weight	Gonadotropins	18.5- 24.9 kg/m2
Normal weight	Human chorionic gonadotropin Chorimon	18.5- 24.9 kg/m2
Obese	GNRH antagonist	BMI ≥ 30 kg/m2
Obese	Natural progesterone	BMI ≥ 30 kg/m2
Normal weight	Natural progesterone	18.5- 24.9 kg/m2
Obese	Gonadotropins	BMI ≥ 30 kg/m2
Obese	Human chorionic gonadotropin Chorimon	BMI ≥ 30 kg/m2

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate	4 weeks after HCG triggering	appearance of intrauterine gestational sac by transvaginal ultrasound

Secondary Outcome Measures

Name	Time	Method