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CompletedNCT03778684Updated Nov 30, 2022

Obesity and Intracytoplasmic Sperm Injection Cycle Outcome

An interventional study of Visceral fat thickness and Body mass index in Infertility, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2022-11-30.

Sponsored by Assiut University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Non-randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study summary

Obesity has been associated with menstrual irregularities, chronic an-ovulation, infertility, and poor outcomes in women undergoing in vitro fertilization.

There is strong evidence that obesity is associated with a higher n vitro fertilization cycle cancellation rate (despite administration of higher doses of exogenous gonadotrophins), a lower mature oocyte yield and lower number of cryopreservation cycles.

Furthermore, obese women have been shown to have impaired response to ovarian stimulation and significantly lower live births after in vitro fertilization. Indeed, obesity affects many ovarian intra-follicular steroidogenic, metabolic and inflammatory pathways.This is particularly evident in women with abdominal (central obesity). Waist circumference measurement is used to identify individuals with abdominal obesity but it cannot differentiate between intra-abdominal fat and subcutaneous abdominal fat accumulation.

The reliable measurement of visceral fat and subcutaneous fat is not only important as a tool to predict cardiovascular and metabolic disease risk, but it is also essential to evaluate the effect of these fat compartments on female reproductive function. Intra-abdominal fat accumulation is related to insulin resistance in women with polycystic ovary syndrome and in these women the resulting hyperinsulinemia contributes to an-ovulation.

Obese anovulatory women with polycystic ovary syndrome who resume ovulation during a 6-month lifestyle program lose more visceral fat with no difference in the change of subcutaneous fat compared to the women who did not resume ovulation.

Another recent study that enrolled 140 non-polycystic ovary syndrome in vitro fertilization women demonstrated that women with increased waist circumference and higher follicular fluid leptin have less oocytes fertilized and failed in vitro fertilization outcomes. Increased intra-abdominal fat during early pregnancy is associated with insulin resistance and increased diastolic blood pressure and it can predict glucose intolerance in later pregnancy.

02

Conditions studied

  • Infertility

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03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 88 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Age of women 18 - 35 yrs old.
  • Women with Body mass index I 18 - 35 kg/m2.
  • Infertile women with an indication for In vitro fertilization
  • Anticipated normal responders.
  • Normal uterine cavity by trans-vaginal ultrasound.

Exclusion criteria

Exclusion Criteria:

  • Poly cystic ovarian syndrome
  • Diabetic patients.
  • Known Poor ovarian response
  • Patients with abnormal uterine cavity.
  • Refusal to participate in the study.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    Normal Body mass index without central obesity

    Diagnostic Test: Visceral fat thickness · Diagnostic Test: Body mass index

  • Experimental
    High Body mass index with central obesity

    Diagnostic Test: Visceral fat thickness · Diagnostic Test: Body mass index

Interventions

  • Diagnostic testVisceral fat thickness

    An initial longitudinal sweep will be done from the xiphoid process to the umbilicus to determine the area of maximum pre-peritoneal fat thickness.

  • Diagnostic testBody mass index

    Weight and height will be measured with subjects in a standing position wearing light clothes and no shoes.

06

What researchers measure

Primary outcomes

  1. Number of women will be pregnant (clinical pregnancy rate)

    a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy.

    Time frame: 1 month

07

Study locations

1 site
  • Women Health Hospital - Assiut university
    Assiut, 71111, Egypt
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03778684
Lead sponsor
Assiut University
Responsible party
Alaa Ahmad Mohamed Makhlouf (Assistant Lecturer, Assiut University) — Principal investigator
First posted
Dec 19, 2018
Start date
Feb 1, 2019
Primary completion
Mar 1, 2022
Completion
Nov 26, 2022
Last update
Nov 30, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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