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
1 other identifier
interventional
185
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 3, 2015
CompletedFirst Submitted
Initial submission to the registry
February 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedFirst Posted
Study publicly available on registry
March 7, 2018
CompletedMarch 7, 2018
March 1, 2018
3.2 years
February 25, 2018
March 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
clinical pregnancy rate
appearance of intrauterine gestational sac by transvaginal ultrasound
4 weeks after HCG triggering
Study Arms (3)
Normal weight
ACTIVE COMPARATOR18.5- 24.9 kg/m2
Overweight
ACTIVE COMPARATORBMI 25-29.9 kg/m2
Obese
ACTIVE COMPARATORBMI ≥ 30 kg/m2
Interventions
1\) Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration
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
10000 IU of HCG are given intramuscular when 2 or more mature follicles reach 18 - 20 mm
400 mg vaginal tablets twice daily from the day of ovum pick up till HCG tesing
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any factor which may affect reproductive outcome other than that the patient is a poor responder will be excluded from the study, like:
- Severe male factor .
- Uterine factor (eg: fibroid, polyp, Ashermann, .. etc)
- Immunological disorder (eg: SLE, APS, … etc)
- Thyroid or adrenal dysfunction
- Neoplasia (especially: hypothalamic, pit, ovarian)
- Women diagnosed with PCOS according to Rotterdam criteria
- Hydrosalpinx that hasn't been surgically removed or ligated.
- Untreated hyperprolactinemia
- Abnormal bleeding disorder
- Hepatic or renal dysfunction
- Hypersenstivity to study medication ( GNRH antagonist)
- Need to take medication that can influence ovarian stimulation
- Endometriosis grade 3 or 4
- Ovarian cyst\> 10 cm.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Kasr Alainy medical school
Cairo, 12111, Egypt
Related Publications (1)
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.
PMID: 30407618DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Maged
professor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
February 25, 2018
First Posted
March 7, 2018
Study Start
January 3, 2015
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
March 7, 2018
Record last verified: 2018-03