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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-03

Study Completion Date

2018-03-31

Brief Summary

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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

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Detailed Description

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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

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Invitro Fertilization

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Normal weight

18.5- 24.9 kg/m2

Group Type ACTIVE_COMPARATOR

Gonadotropins

Intervention Type DRUG

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

GNRH antagonist

Intervention Type DRUG

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

Human chorionic gonadotropin Chorimon

Intervention Type DRUG

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

Natural progesterone

Intervention Type DRUG

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

Overweight

BMI 25-29.9 kg/m2

Group Type ACTIVE_COMPARATOR

Gonadotropins

Intervention Type DRUG

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

GNRH antagonist

Intervention Type DRUG

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

Human chorionic gonadotropin Chorimon

Intervention Type DRUG

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

Natural progesterone

Intervention Type DRUG

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

Obese

BMI ≥ 30 kg/m2

Group Type ACTIVE_COMPARATOR

Gonadotropins

Intervention Type DRUG

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

GNRH antagonist

Intervention Type DRUG

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

Human chorionic gonadotropin Chorimon

Intervention Type DRUG

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

Natural progesterone

Intervention Type DRUG

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

Interventions

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Gonadotropins

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

Intervention Type 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

Intervention Type DRUG

Human chorionic gonadotropin Chorimon

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

Intervention Type DRUG

Natural progesterone

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

Intervention Type DRUG

Other Intervention Names

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Human menopausal gonadotropin cetrorelix HCG prontogest

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No