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Not yet recruitingNCT07832825Updated Sep 22, 2026

Effect of Body Mass Index on ICSI Outcomes

An observational study in Infertility, Obesity and Pregnancy Complications, sponsored by Assiut University. Not yet recruiting. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
350
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Infertility
  • Obesity
  • Pregnancy Complications

Keywords

  • ICSI
  • In vitro fertilization
  • Obesity
  • Pregnancy rate
  • Assiut
03

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's planned enrollment of 350 is above the median of 200 across 592 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Cases with no recorded weight or height at registration
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
350 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Clinical Pregnancy Rate After ICSI

    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

    Time frame: At 6 weeks after embryo transfer

Secondary outcomes

  1. Ongoing Pregnancy Rate

    Proportion of pregnancies continuing beyond 12 weeks gestation among women who achieved clinical pregnancy stratified by BMI groups

    Time frame: At 12 weeks after embryo transfer

  2. Clinical Abortion Rate

    Proportion of clinical pregnancies that result in pregnancy loss before 20 weeks gestation among BMI groups

    Time frame: Up to 20 weeks after embryo transfer

  3. Live Birth Rate

    Proportion of ICSI cycles resulting in live birth among BMI groups

    Time frame: At 40 weeks after embryo transfer

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2026, 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
NCT07832825
Lead sponsor
Assiut University
Responsible party
Hager Mikhamer Mohamed sayed (Resident Physician, Assiut University) — Principal investigator
First posted
Sep 22, 2026
Start date
Sep 20, 2026 (estimated)
Primary completion
Sep 20, 2027 (estimated)
Completion
Mar 20, 2028 (estimated)
Last update
Sep 22, 2026

Study contacts

Hager M Mohamed, Resident
Contact
hagar.18313516@med.aun.edu.eg
01554546780
Ahmed N Fatieh, prof
study chair · obstetric and gynecology Department, Assiut University Hospitals

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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