InfertilityNCT07832825
Effect of Body Mass Index on ICSI Outcomes
An observational study of Infertility and Obesity, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility, Obesity, Pregnancy Complications
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 20 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who underwent intracytoplasmic sperm injection cycles at Assiut Women Health Hospital between January 2020 and December 2026.
Who may be able to join
- Women who underwent ICSI cycles at Assiut Women Health Hospital
- Recorded weight and height at the start of treatment
Who cannot join
- Cases with no recorded weight or height at registration
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Conditions
- Infertility, Obesity, Pregnancy Complications
- Keywords
- ICSI, In vitro fertilization, Obesity, Pregnancy rate, Assiut
- Medical subject headings
- Infertility, Obesity, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 6 weeks after embryo transfer
Secondary outcomes (3)
Ongoing Pregnancy Rate
Proportion of pregnancies continuing beyond 12 weeks gestation among women who achieved clinical pregnancy stratified by BMI groups
Measured: At 12 weeks after embryo transfer
Clinical Abortion Rate
Proportion of clinical pregnancies that result in pregnancy loss before 20 weeks gestation among BMI groups
Measured: Up to 20 weeks after embryo transfer
Live Birth Rate
Proportion of ICSI cycles resulting in live birth among BMI groups
Measured: At 40 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion20 Sep 2027 (estimated)
- Study completion20 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Mikhamer Mohamed sayed, Assiut University
- Investigators
- Ahmed N Fatieh, prof, Study chair, obstetric and gynecology Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832825
- Sponsor's protocol ID
- BMI-ICSI-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Body Mass Index on Intracytoplasmic Sperm Injection Cycles
- ClinicalTrials.gov ID
- NCT07832825
- Acronym / sponsor ID
- BMI-ICSI-Assiut-2026
- Conditions
- Infertility, Obesity, Pregnancy Complications
- Keywords
- ICSI, In vitro fertilization, Obesity, Pregnancy rate, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 20 Sep 2027 (estimated)
- Study completion
- 20 Mar 2028 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who underwent intracytoplasmic sperm injection cycles at Assiut Women Health Hospital between January 2020 and December 2026.
Key inclusion criteria (2 listed)
- Women who underwent ICSI cycles at Assiut Women Health Hospital
- Recorded weight and height at the start of treatment
Key exclusion criteria (1 listed)
- Cases with no recorded weight or height at registration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Ongoing Pregnancy Rate
Time frame: At 12 weeks after embryo transfer
Clinical Abortion Rate
Time frame: Up to 20 weeks after embryo transfer
Live Birth Rate
Time frame: At 40 weeks after embryo transfer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed N Fatieh, prof study chair
obstetric and gynecology Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Obesity, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hager M Mohamed, Resident (01554546780, hagar.18313516@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy Rate After ICSI (time frame: At 6 weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.