Effect of Body Mass Index on ICSI Outcomes

September 16, 2026 updated by: Hager Mikhamer Mohamed sayed, Assiut University

Effect of Body Mass Index on Intracytoplasmic Sperm Injection Cycles

This retrospective cohort study aims to evaluate the effect of body mass index on the outcomes of intracytoplasmic sperm injection (ICSI) cycles at Assiut Women Health Hospital.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Obesity is associated with alterations in reproductive function and may affect the success of assisted reproductive techniques. This observational study will review medical records of women who underwent ICSI cycles.

Patients will be classified according to the World Health Organization body mass index categories: underweight (<18.5 kg/m²), normal weight (18.5-24.99 kg/m²), overweight (25-29.99 kg/m²), and obese (≥30 kg/m²). Pregnancy outcomes will be compared across BMI groups.

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women who underwent intracytoplasmic sperm injection cycles at Assiut Women Health Hospital between January 2020 and December 2026.

Description

Inclusion Criteria:

  • Women who underwent ICSI cycles at Assiut Women Health Hospital
  • Recorded weight and height at the start of treatment

Exclusion Criteria:

  • Cases with no recorded weight or height at registration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: RETROSPECTIVE

Cohorts and Interventions

Group / Cohort
Underweight

BMI < 18.5 kg/m² Women classified according to World Health Organization body mass index categories who underwent ICSI cycles.
Normal weight

BMI 18.5-24.99 kg/m² Women classified according to World Health Organization body mass index categories who underwent ICSI cycles.
Overweight

BMI 25-29.99 kg/m² Women classified according to World Health Organization body mass index categories who underwent ICSI cycles.
Obese

BMI ≥ 30 kg/m² Women classified according to World Health Organization body mass index categories who underwent ICSI cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Pregnancy Rate After ICSI
Time Frame: At 6 weeks after embryo transfer

Proportion of women achieving clinical pregnancy defined as positive serum beta-hCG and presence of gestational sac on ultrasound among total ICSI cycles stratified by BMI groups
At 6 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing Pregnancy Rate
Time Frame: At 12 weeks after embryo transfer

Proportion of pregnancies continuing beyond 12 weeks gestation among women who achieved clinical pregnancy stratified by BMI groups
At 12 weeks after embryo transfer
Clinical Abortion Rate
Time Frame: Up to 20 weeks after embryo transfer

Proportion of clinical pregnancies that result in pregnancy loss before 20 weeks gestation among BMI groups
Up to 20 weeks after embryo transfer
Live Birth Rate
Time Frame: At 40 weeks after embryo transfer

Proportion of ICSI cycles resulting in live birth among BMI groups
At 40 weeks after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Ahmed N Fatieh, prof, obstetric and gynecology Department, Assiut University Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 20, 2026

Primary Completion (Estimated)

September 20, 2027

Study Completion (Estimated)

March 20, 2028

Study Registration Dates

First Submitted

September 16, 2026

First Submitted That Met QC Criteria

September 16, 2026

First Posted (Actual)

September 22, 2026

Study Record Updates

Last Update Posted (Actual)

September 22, 2026

Last Update Submitted That Met QC Criteria

September 16, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMI-ICSI-Assiut-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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