InfertilityNCT07836400
Half-dose vs Conventional-dose Cetrorelix in ICSI Cycles
An observational study of Infertility and Infertility, Female, run by Assiut University.
Trial summary
This prospective cohort study aims to compare the effectiveness of half-dose (0.125 mg/day) versus conventional-dose (0.25 mg/day) cetrorelix in GnRH antagonist ICSI cycles regarding clinical pregnancy rate in women with BMI ≥25 kg/m². Read more about this study
- Who is it for?
- Ages 18 to 34 years, women only
- Conditions the study is for
- Infertility, Infertility, Female, Anovulation
- How many people
- 160 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 34 years
- Women only
- No healthy volunteers
- Adult
Study population: Women aged less than 35 years with BMI ≥25 kg/m² and normal ovarian reserve who received either half-dose or conventional-dose cetrorelix as part of routine care during GnRH antagonist ICSI cycles at Assiut University Hospital.
Who may be able to join
- - Age less than 35 years
- Normal ovarian responders (AMH ≥1.2 ng/mL and AFC 5-15)
- Body mass index (BMI) ≥25 kg/m²
- Written informed consent
Who cannot join
- - Age greater than 35 years
- Diminished ovarian reserve (AMH <1.2 ng/mL or AFC <5)
- Congenital uterine anomalies or significant intrauterine pathology
- Contraindications to ovarian stimulation or pregnancy
- Refusal to participate
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: Half-dose Versus Conventional-dose Cetrorelix in Antagonist ICSI Cycles: Prospective Comparative Cohort Study
This prospective cohort study aims to compare the effectiveness of half-dose (0.125 mg/day) versus conventional-dose (0.25 mg/day) cetrorelix in GnRH antagonist ICSI cycles regarding clinical pregnancy rate in women with BMI ≥25 kg/m².
Read the detailed description
Cetrorelix is used as a GnRH antagonist to prevent premature LH surge during controlled ovarian stimulation for ICSI. This observational study will include women aged less than 35 years with normal ovarian reserve and BMI ≥25 kg/m² who received either half-dose or conventional-dose cetrorelix as part of routine care. Clinical pregnancy rate and secondary reproductive outcomes will be compared between the two groups.
- Conditions
- Infertility, Infertility, Female, Anovulation
- Keywords
- Half-dose, Cetrorelix, ICSI, GnRH Antagonist, Assiut
- Medical subject headings
- Infertility, Infertility, Female, Anovulation
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 |
|---|---|---|
| Half-dose Cetrorelix 0.125 mg | Women who received cetrorelix 0.125 mg daily as part of routine GnRH antagonist protocol. | |
| Conventional-dose Cetrorelix 0.25 mg | Women who received cetrorelix 0.25 mg daily as part of routine GnRH antagonist protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rate
Proportion of women with intrauterine gestational sac with fetal heartbeat by ultrasound at 6 weeks gestation
Measured: 6 weeks after embryo transfer
Secondary outcomes (5)
Ongoing pregnancy rate
Ongoing pregnancy with heartbeat >12 weeks on ultrasound
Measured: 12 weeks after embryo transfer
Number of retrieved oocytes
Mean number of oocytes retrieved at pickup
Measured: Periprocedurally, at time of oocyte retrieval, during oocyte pickup procedure
Number of mature MII oocytes
Mean number of mature MII oocytes
Measured: Periprocedurally , at time of oocyte retrieval, Day 0, during oocyte pickup procedure
Fertilization rate
Fertilized oocytes / MII oocytes
Measured: 1 day after ICSI
Premature LH surge
LH >=10 IU/L or progesterone >=1.0 ng/mL before trigger
Measured: Baseline (before hCG trigger)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 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
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Ahmed Mohy Eldien, Assiut University
- Investigators
- Mohamed S Abdallah, prof, Study chair, obstetrics and gynecology Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836400
- Sponsor's protocol ID
- CETRO-ICSI-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Half-dose Versus Conventional-dose Cetrorelix in Antagonist ICSI Cycles: Prospective Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT07836400
- Acronym / sponsor ID
- CETRO-ICSI-Assiut-2026
- Conditions
- Infertility, Infertility, Female, Anovulation
- Keywords
- Half-dose, Cetrorelix, ICSI, GnRH Antagonist, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 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
- 23 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 prospective cohort study aims to compare the effectiveness of half-dose (0.125 mg/day) versus conventional-dose (0.25 mg/day) cetrorelix in GnRH antagonist ICSI cycles regarding clinical pregnancy rate in women with BMI ≥25 kg/m².
Detailed description
Cetrorelix is used as a GnRH antagonist to prevent premature LH surge during controlled ovarian stimulation for ICSI. This observational study will include women aged less than 35 years with normal ovarian reserve and BMI ≥25 kg/m² who received either half-dose or conventional-dose cetrorelix as part of routine care. Clinical pregnancy rate and secondary reproductive outcomes will be compared between the two groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Half-dose Cetrorelix 0.125 mg | – | –Women who received cetrorelix 0.125 mg daily as part of routine GnRH antagonist protocol. |
| Conventional-dose Cetrorelix 0.25 mg | – | –Women who received cetrorelix 0.25 mg daily as part of routine GnRH antagonist protocol. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women aged less than 35 years with BMI ≥25 kg/m² and normal ovarian reserve who received either half-dose or conventional-dose cetrorelix as part of routine care during GnRH antagonist ICSI cycles at Assiut University Hospital.
Key inclusion criteria (4 listed)
- - Age less than 35 years
- Normal ovarian responders (AMH ≥1.2 ng/mL and AFC 5-15)
- Body mass index (BMI) ≥25 kg/m²
- Written informed consent
Key exclusion criteria (5 listed)
- - Age greater than 35 years
- Diminished ovarian reserve (AMH <1.2 ng/mL or AFC <5)
- Congenital uterine anomalies or significant intrauterine pathology
- Contraindications to ovarian stimulation or pregnancy
- Refusal to participate
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
Time frame: 6 weeks after embryo transfer
Proportion of women with intrauterine gestational sac with fetal heartbeat by ultrasound at 6 weeks gestation
5 secondary outcomes
Ongoing pregnancy rate
Time frame: 12 weeks after embryo transfer
Number of retrieved oocytes
Time frame: Periprocedurally, at time of oocyte retrieval, during oocyte pickup procedure
Number of mature MII oocytes
Time frame: Periprocedurally , at time of oocyte retrieval, Day 0, during oocyte pickup procedure
Fertilization rate
Time frame: 1 day after ICSI
Premature LH surge
Time frame: Baseline (before hCG trigger)
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 23 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.
Mohamed S Abdallah, prof study chair
obstetrics and gynecology Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Infertility, Female, 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 4 inclusion and 5 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 23 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 Samar A Mohy eldin, Resident (01142926439, samarmohy42@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy Rate (time frame: 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 23 Sep 2026.