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

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

Study Overview

• Status: Unknown
• Conditions: Invitro Fertilization
• Intervention / Treatment: Drug: Gonadotropins; Drug: GNRH antagonist; Drug: Human chorionic gonadotropin Chorimon; Drug: Natural progesterone

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

• Study Type: Interventional
• Enrollment (Anticipated): 185
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12111
    • Recruiting
    • Kasr Alainy Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Normal weight; 18.5- 24.9 kg/m2	Drug: Gonadotropins; 1) Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration; Other Names: Human menopausal gonadotropin; 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; Other Names: cetrorelix; Drug: Human chorionic gonadotropin Chorimon; 10000 IU of HCG are given intramuscular when 2 or more mature follicles reach 18 - 20 mm; Other Names: HCG; Drug: Natural progesterone; 400 mg vaginal tablets twice daily from the day of ovum pick up till HCG tesing; Other Names: prontogest
Active Comparator: Overweight; BMI 25-29.9 kg/m2	Drug: Gonadotropins; 1) Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration; Other Names: Human menopausal gonadotropin; 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; Other Names: cetrorelix; Drug: Human chorionic gonadotropin Chorimon; 10000 IU of HCG are given intramuscular when 2 or more mature follicles reach 18 - 20 mm; Other Names: HCG; Drug: Natural progesterone; 400 mg vaginal tablets twice daily from the day of ovum pick up till HCG tesing; Other Names: prontogest
Active Comparator: Obese; BMI ≥ 30 kg/m2	Drug: Gonadotropins; 1) Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration; Other Names: Human menopausal gonadotropin; 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; Other Names: cetrorelix; Drug: Human chorionic gonadotropin Chorimon; 10000 IU of HCG are given intramuscular when 2 or more mature follicles reach 18 - 20 mm; Other Names: HCG; Drug: Natural progesterone; 400 mg vaginal tablets twice daily from the day of ovum pick up till HCG tesing; Other Names: prontogest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy rate	appearance of intrauterine gestational sac by transvaginal ultrasound	4 weeks after HCG triggering

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Maged AM, Fahmy RM, Rashwan H, Mahmood M, Hassan SM, Nabil H, Hany A, Lotfy R, Lasheen YS, Dahab S, Darwish M. Effect of body mass index on the outcome of IVF cycles among patients with poor ovarian response. Int J Gynaecol Obstet. 2019 Feb;144(2):161-166. doi: 10.1002/ijgo.12706. Epub 2018 Nov 26.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2015
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: February 25, 2018
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): March 7, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Progestins; Chorionic Gonadotropin; Cetrorelix; Menotropins; Progesterone
• Other Study ID Numbers: 31 (Other Identifier: IASO Thessalias)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No