InfertilityNCT05969834
HCG Levels After Ovulation Triggering as Predictors of ICSI Outcome
An observational study of Infertility, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aimed to assess the correlation between HCG levels after ovulation triggering and ICSI outcomes, affected by HCG formulation and dose Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- uHCG, rHCG and uHCG and GnRHa
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Mar 2021to 7 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who will undergo controlled ovarian stimulation (COS) through fixed GnRH antagonist protocol with ovulation triggering, according to the risk of OHSS, by: 1) urinary HCG (uHCG); 2) recombinant HCG (rHCG); or 3) a combination of GnRHa and HCG (dual trigger)
Who may be able to join
- Women who will undergo controlled ovarian stimulation (COS) through fixed GnRH antagonist protocol
Who cannot join
- BMI > 30 kg/m2
- Irregular menstruation
- Severe male factor abnormality
- Poor ovarian reserve
- Endometriosis
- Uterine abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human Chorionic Gonadotropin Levels After Ovulation Triggering as Predictors of Intracytoplasmic Sperm Injection Outcome
This study aimed to assess the correlation between HCG levels after ovulation triggering and ICSI outcomes, affected by HCG formulation and dose
Read the detailed description
The aims of this study are:
- To assess the correlation between serum human chorionic gonadotropin (hCG) level after ovulation triggering and intracytoplasmic sperm injection (ICSI) outcome including: oocyte maturity and quality, good quality embryo rate, blastocyst formation rate and pregnancy rate
- To determine if there is an association between type and dose of the trigger and ICSI outcome.
- Conditions
- Infertility
- Being tested
- uHCG, rHCG, uHCG and GnRHa
- Keywords
- Ovulation triggering, uHCG, rHCG, GnRH, Dual trigger
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uHCGDrug
Also called Choriomon
Final oocyte maturation will be triggered by IM administration of 10000 IU of uHCG (Choriomon)
rHCGDrug
Also called Ovitrelle
Final oocyte maturation will be triggered by SC administration of 6500 IU of rHCG (Ovitrelle)
uHCG and GnRHaDrug
Also called Decapeptyl and Choriomon
Final oocyte maturation will be triggered by combined SC administration of 0.1 mg of GnRHa (Decapeptyl, Triptorelin) and IM administration of 2500 IU of uHCG (Choriomon)
| Study group | Role | What they receive |
|---|---|---|
| uHCG group | Trigger intramuscular (IM) administration of 10000 IU of uHCG Receives: Drug: uHCG | |
| rHCG group | Trigger with subcutaneous (SC) administration of 6500 IU of rHCG Receives: Drug: rHCG | |
| Dual trigger group | Combined SC administration of 0.1 mg of GnRHa and IM administration of 2500 IU of uHCG Receives: Drug: uHCG and GnRHa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures
Measured: 6 weeks after embryo transfer
Secondary outcomes (1)
Oocyte maturation rate
Number of mature oocytes divided by the number of retrieved oocytes
Measured: On 1 day of oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start31 Mar 2021
- Primary completion19 Jul 2022
- Study completion7 Aug 2022
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 Mansoura 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Engy Abdallah, MSc, Principal investigator, Mansoura UniversityMohamed S Abdelhafez, MD, Study director, Mansoura UniversityMohamed Elzayat, MD, Study chair, Royal CenterAmoura Abou-ElNaga, MD, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969834
- Sponsor's protocol ID
- MD.20.09.370
- Status last verified
- Jul 2023
- First submitted
- 24 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Chorionic Gonadotropin Levels After Ovulation Triggering as Predictors of Intracytoplasmic Sperm Injection Outcome
- ClinicalTrials.gov ID
- NCT05969834
- Acronym / sponsor ID
- MD.20.09.370
- Conditions
- Infertility
- Keywords
- Ovulation triggering, uHCG, rHCG, GnRH, Dual trigger
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 7 Aug 2022 (actual)
- First posted
- 1 Aug 2023 (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 study aimed to assess the correlation between HCG levels after ovulation triggering and ICSI outcomes, affected by HCG formulation and dose
Detailed description
The aims of this study are:
- To assess the correlation between serum human chorionic gonadotropin (hCG) level after ovulation triggering and intracytoplasmic sperm injection (ICSI) outcome including: oocyte maturity and quality, good quality embryo rate, blastocyst formation rate and pregnancy rate
- To determine if there is an association between type and dose of the trigger and ICSI outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| uHCG group | – | Drug: uHCGTrigger intramuscular (IM) administration of 10000 IU of uHCG |
| rHCG group | – | Drug: rHCGTrigger with subcutaneous (SC) administration of 6500 IU of rHCG |
| Dual trigger group | – | Drug: uHCG and GnRHaCombined SC administration of 0.1 mg of GnRHa and IM administration of 2500 IU of uHCG |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who will undergo controlled ovarian stimulation (COS) through fixed GnRH antagonist protocol with ovulation triggering, according to the risk of OHSS, by: 1) urinary HCG (uHCG); 2) recombinant HCG (rHCG); or 3) a combination of GnRHa and HCG (dual trigger)
Key inclusion criteria (1 listed)
- Women who will undergo controlled ovarian stimulation (COS) through fixed GnRH antagonist protocol
Key exclusion criteria (6 listed)
- BMI > 30 kg/m2
- Irregular menstruation
- Severe male factor abnormality
- Poor ovarian reserve
- Endometriosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uHCGAlso: ChoriomonFinal oocyte maturation will be triggered by IM administration of 10000 IU of uHCG (Choriomon) | Drug | uHCG group |
| rHCGAlso: OvitrelleFinal oocyte maturation will be triggered by SC administration of 6500 IU of rHCG (Ovitrelle) | Drug | rHCG group |
| uHCG and GnRHaAlso: Decapeptyl and ChoriomonFinal oocyte maturation will be triggered by combined SC administration of 0.1 mg of GnRHa (Decapeptyl, Triptorelin) and IM administration of 2500 IU of uHCG (Choriomon) | Drug | Dual trigger group |
Primary outcome
Clinical pregnancy rate
Time frame: 6 weeks after embryo transfer
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures
1 secondary outcome
Oocyte maturation rate
Time frame: On 1 day of oocyte retrieval
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Engy Abdallah, MSc principal investigator
Mansoura University
Mohamed S Abdelhafez, MD study director
Mansoura University
Mohamed Elzayat, MD study chair
Royal Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 1 Aug 2023.