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OpenTrials
Completed

NCT Number: NCT03778684

Obesity and Intracytoplasmic Sperm Injection Cycle Outcome

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Visceral fat thickness

Diagnostic Test

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

Body mass index

Diagnostic Test

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

Primary outcomes

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

    Time frame: 1 month

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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Impact of Obesity on Intracytoplasmic Sperm Injection Cycle Outcome: a Prospective Cohort Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 19, 2018
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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