InfertilityNCT06966219
Trigger Protocol on the Rate of Pregnancy After Intracytoplasmic Sperm Injection
An observational study of Infertility, run by Suez University at 1 site in Egypt.
Trial summary
Infertility is a condition affecting both female and male, characterized by the inability to conceive after 12 months or more of regular, unprotected sexual activity. All over the world, over 186 million people are affected by this condition, with the majority living in developing countries. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Intracytoplasmic sperm injection
- Type of treatment
- Injection or infusion
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 31 Jul 2025
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Study population: females attended the clinic with a history of infertility required Intracytoplasmic sperm inaction
Who may be able to join
- Patients are less than 38 years old
- Patients have primary or secondary infertility
- Patient is candidate for ICSI
- Normal antral follicles count
- AMH more than 1
Who cannot join
- Age more than 38 years old
- Patients have other options for assisted reproductive techniques like
- intrauterine insemination.
- Severe male factor
- AMH less than 1
- Recurrent ICSI failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Trigger Protocol on the Rate of Pregnancy After Intracytoplasmic Sperm Injection: A Prospective Cohort Study
Infertility is a condition affecting both female and male, characterized by the inability to conceive after 12 months or more of regular, unprotected sexual activity. All over the world, over 186 million people are affected by this condition, with the majority living in developing countries. In developing countries, the prevalence of infertility among women of reproductive age is estimated to affect one in every four couples. Type of the trigger during intracytoplasmic sperm injection might has impact on pregnancy rate.
Read the detailed description
When 3rd generation Gonadotropin-releasing hormone antagonists (GnRH-a) were introduced in the 1990s for ovarian induction protocols, it became possible to trigger final oocyte maturation and ovulation with a single bolus of GnRH-a as an alternative to Human chorionic gonadotropin (HCG). Although some studies have suggested an increase in the percentage of mature 2 ((MII) oocytes retrieved with GnRH-a compared to HCG, it has been found that triggering ovulation with only GnRH agonist leads to a suboptimal luteal phase. The term "dual trigger" was first defined as the combination of a GnRH agonist and a low dose of HCG for triggering terminal oocyte maturation and avoid ovarian hyperstimulation syndrome (OHSS) in GnRH antagonist protocols.
Lin et al, conducted a retrospective study represent normal responders undergoing intracytoplasmic sperm injection )ICSI (with a GnRH antagonist trigger. They demonstratedsignificant improvements in the total number of retrieved oocytes, the number of mature (MII) oocytes, and rates of embryo implantation, clinical pregnancy, ongoing pregnancy, and live birth rate when the dual trigger protocol was used. Similarly, Lu et al. presented a retrospective analysis of fertility centers records where final oocyte maturation was triggered by either GnRH alone (Decapeptyl 0.1-0.2 mg) or in combination with HCG (1,000, 2,000, or 5,000 IU). They concluded that employing a dual trigger with a low dose of hCG (1,000 IU) as an adjunct to GnRH-a significantly improved the oocyte retrieval rate in suboptimal responders.
- Conditions
- Infertility
- Being tested
- Intracytoplasmic sperm injection
- Keywords
- icsi, 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.
Intracytoplasmic sperm injectionOther
- All patients will commence controlled ovarian hyperstimulation (COH) on day 2 or 3 of their menstrual cycle. The initial treatment will be a daily administration of either highly purified human menopausal gonadotropin (hMG) or recombinant FSH (rFSH, Gonal-F 150 IU, Merck Serono, S.P.A, Italy) administered subcutaneously and intramuscularly for a duration of 10-12 days. The treatment will be continued until the final oocyte maturation. The starting dosage will be tailored based on the patient's age, antral follicle count (AFC), body mass index (BMI), serum FSH and AMH levels on days 2-3, as well as the patient's previous response to COH.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Ninety women presenting with infertility were recruited from the outpatient clinic. Baseline data, including demographic and medical history, BMI, and laboratory investigations (CBC, renal and liver function tests, coagulation profile along with hormonal profile ), were collected. All patients underwent intracytoplasmic sperm injection for infertility. Receives: Other: Intracytoplasmic sperm injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate after dual versus single trigger during ICSI
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start1 May 2025
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Sewidan, Suez University
- Investigators
- Wessam aboelghar, Principal investigator, faculty of medicine, Suez university Suez, Suez, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966219
- Sponsor's protocol ID
- 3
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin MH, Wu FS, Lee RK, Li SH, Lin SY, Hwu YM. Dual trigger with combination of gonadotropin-releasing hormone agonist and human chorionic gonadotropin significantly improves the live-birth rate for normal responders in GnRH-antagonist cycles. Fertil Steril. 2013 Nov;100(5):1296-302. doi: 10.1016/j.fertnstert.2013.07.1976. Epub 2013 Aug 28.
PubMed 23993928Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Thomas S. Gonadotropin-releasing hormone agonist combined with a reduced dose of human chorionic gonadotropin for final oocyte maturation in fresh autologous cycles of in vitro fertilization. Fertil Steril. 2008 Jul;90(1):231-3. doi: 10.1016/j.fertnstert.2007.06.030. Epub 2007 Nov 5.
PubMed 17981269Segal S, Casper RF. Gonadotropin-releasing hormone agonist versus human chorionic gonadotropin for triggering follicular maturation in in vitro fertilization. Fertil Steril. 1992 Jun;57(6):1254-8.
PubMed 1601147Humaidan P, Westergaard LG, Mikkelsen AL, Fukuda M, Yding Andersen C. Levels of the epidermal growth factor-like peptide amphiregulin in follicular fluid reflect the mode of triggering ovulation: a comparison between gonadotrophin-releasing hormone agonist and urinary human chorionic gonadotrophin. Fertil Steril. 2011 May;95(6):2034-8. doi: 10.1016/j.fertnstert.2011.02.013. Epub 2011 Mar 5.
PubMed 21377153Mascarenhas MN, Flaxman SR, Boerma T, Vanderpoel S, Stevens GA. National, regional, and global trends in infertility prevalence since 1990: a systematic analysis of 277 health surveys. PLoS Med. 2012;9(12):e1001356. doi: 10.1371/journal.pmed.1001356. Epub 2012 Dec 18.
PubMed 23271957
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Trigger Protocol on the Rate of Pregnancy After Intracytoplasmic Sperm Injection: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06966219
- Acronym / sponsor ID
- 3
- Conditions
- Infertility
- Keywords
- icsi, dual trigger
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Suez UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 11 May 2025 (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.
Infertility is a condition affecting both female and male, characterized by the inability to conceive after 12 months or more of regular, unprotected sexual activity. All over the world, over 186 million people are affected by this condition, with the majority living in developing countries. In developing countries, the prevalence of infertility among women of reproductive age is estimated to affect one in every four couples. Type of the trigger during intracytoplasmic sperm injection might has impact on pregnancy rate.
Detailed description
When 3rd generation Gonadotropin-releasing hormone antagonists (GnRH-a) were introduced in the 1990s for ovarian induction protocols, it became possible to trigger final oocyte maturation and ovulation with a single bolus of GnRH-a as an alternative to Human chorionic gonadotropin (HCG). Although some studies have suggested an increase in the percentage of mature 2 ((MII) oocytes retrieved with GnRH-a compared to HCG, it has been found that triggering ovulation with only GnRH agonist leads to a suboptimal luteal phase. The term "dual trigger" was first defined as the combination of a GnRH agonist and a low dose of HCG for triggering terminal oocyte maturation and avoid ovarian hyperstimulation syndrome (OHSS) in GnRH antagonist protocols.
Lin et al, conducted a retrospective study represent normal responders undergoing intracytoplasmic sperm injection )ICSI (with a GnRH antagonist trigger. They demonstratedsignificant improvements in the total number of retrieved oocytes, the number of mature (MII) oocytes, and rates of embryo implantation, clinical pregnancy, ongoing pregnancy, and live birth rate when the dual trigger protocol was used. Similarly, Lu et al. presented a retrospective analysis of fertility centers records where final oocyte maturation was triggered by either GnRH alone (Decapeptyl 0.1-0.2 mg) or in combination with HCG (1,000, 2,000, or 5,000 IU). They concluded that employing a dual trigger with a low dose of hCG (1,000 IU) as an adjunct to GnRH-a significantly improved the oocyte retrieval rate in suboptimal responders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Intracytoplasmic sperm injectionNinety women presenting with infertility were recruited from the outpatient clinic. Baseline data, including demographic and medical history, BMI, and laboratory investigations (CBC, renal and liver function tests, coagulation profile along with hormonal profile ), were collected. All patients underwent intracytoplasmic sperm injection for infertility. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- females attended the clinic with a history of infertility required Intracytoplasmic sperm inaction
Key inclusion criteria (5 listed)
- Patients are less than 38 years old
- Patients have primary or secondary infertility
- Patient is candidate for ICSI
- Normal antral follicles count
- AMH more than 1
Key exclusion criteria (6 listed)
- Age more than 38 years old
- Patients have other options for assisted reproductive techniques like
- intrauterine insemination.
- Severe male factor
- AMH less than 1
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 |
|---|---|---|
| Intracytoplasmic sperm injection• All patients will commence controlled ovarian hyperstimulation (COH) on day 2 or 3 of their menstrual cycle. The initial treatment will be a daily administration of either highly purified human menopausal gonadotropin (hMG) or recombinant FSH (rFSH, Gonal-F 150 IU, Merck Serono, S.P.A, Italy) administered subcutaneously and intramuscularly for a duration of 10-12 days. The treatment will be continued until the final oocyte maturation. The starting dosage will be tailored based on the patient's age, antral follicle count (AFC), body mass index (BMI), serum FSH and AMH levels on days 2-3, as well as the patient's previous response to COH. | Other | Group 1 |
Primary outcome
Pregnancy rate after dual versus single trigger during ICSI
Time frame: 3 months
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 13 May 2025.
- Background: PubMed 23993928Lin MH, Wu FS, Lee RK, Li SH, Lin SY, Hwu YM. Dual trigger with combination of gonadotropin-releasing hormone agonist and human chorionic gonadotropin significantly improves the live-birth rate for normal responders in GnRH-antagonist cycles. Fertil Steril. 2013 Nov;100(5):1296-302. doi: 10.1016/j.fertnstert.2013.07.1976. Epub 2013 Aug 28.
- Background: PubMed 17981269Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Thomas S. Gonadotropin-releasing hormone agonist combined with a reduced dose of human chorionic gonadotropin for final oocyte maturation in fresh autologous cycles of in vitro fertilization. Fertil Steril. 2008 Jul;90(1):231-3. doi: 10.1016/j.fertnstert.2007.06.030. Epub 2007 Nov 5.
- Background: PubMed 1601147Segal S, Casper RF. Gonadotropin-releasing hormone agonist versus human chorionic gonadotropin for triggering follicular maturation in in vitro fertilization. Fertil Steril. 1992 Jun;57(6):1254-8.
- Background: PubMed 21377153Humaidan P, Westergaard LG, Mikkelsen AL, Fukuda M, Yding Andersen C. Levels of the epidermal growth factor-like peptide amphiregulin in follicular fluid reflect the mode of triggering ovulation: a comparison between gonadotrophin-releasing hormone agonist and urinary human chorionic gonadotrophin. Fertil Steril. 2011 May;95(6):2034-8. doi: 10.1016/j.fertnstert.2011.02.013. Epub 2011 Mar 5.
- Background: PubMed 23271957Mascarenhas MN, Flaxman SR, Boerma T, Vanderpoel S, Stevens GA. National, regional, and global trends in infertility prevalence since 1990: a systematic analysis of 277 health surveys. PLoS Med. 2012;9(12):e1001356. doi: 10.1371/journal.pmed.1001356. Epub 2012 Dec 18.
- 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. This study is not recruiting at the moment.
Wessam aboelghar principal investigator
faculty of medicine, Suez university Suez, Suez, Egypt
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 Suez 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 5 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: under way, not looking for participants, as of the sponsor's last update on 13 May 2025. 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?
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?
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?
Pregnancy rate after dual versus single trigger during ICSI (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06966219, which also lists 5 linked publications.
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 13 May 2025.