Infertile Patient Undergoing ICSI Proceduretwo injectionNCT07891793
Late-Start Corifollitropin Alfa in Mild Ovarian Stimulation
A study testing Corifollitropin Alfa 150 μg, GnRH antagonist and Progesterone in people with Infertile Patient Undergoing ICSI Procedure, run by Assisting Nature at 1 site in Greece.
Trial summary
This prospective randomized clinical study evaluates a novel physiology-oriented mild ovarian stimulation protocol based on the delayed initiation of corifollitropin alfa. Unlike conventional ovarian stimulation, which begins during the early follicular phase, the proposed protocol postpones exogenous gonadotropin… Read more about this study
- Who is it for?
- Ages 28 to 43 years, women only
- Conditions the study is for
- Infertile Patient Undergoing ICSI Procedure
- What is being tested?
- Corifollitropin Alfa 150 μg, GnRH antagonist and Progesterone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2024to 30 Jun 2026
- Phase
- Interventional
- 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 28 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female participants aged 28 to 43 years at the time of enrollment.
- Clinical diagnosis of infertility requiring IVF or ICSI treatment.
- Planned controlled ovarian stimulation according to the study protocol.
- Anti-Müllerian hormone concentration of 0.2 ng/mL or greater.
- Presence of both ovaries.
- Ability to provide written informed consent.
- Willingness to comply with all study procedures and follow-up assessments.
Who cannot join
- Age younger than 28 years or older than 43 years.
- Anti-Müllerian hormone concentration below 0.2 ng/mL.
- Untreated endocrine disorders that may interfere with ovarian stimulation, including uncontrolled thyroid disease or hyperprolactinemia.
- Contraindication to ovarian stimulation, pregnancy, or transvaginal oocyte retrieval.
- Severe systemic disease considered by the investigator to make participation unsafe.
- Concurrent participation in another interventional clinical study that could interfere with the study outcomes.
- Refusal or inability to provide written informed consent.
- Previous enrollment in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiology-Oriented Mild Ovarian Stimulation: A Randomized Prospective Comparison of Two Strategies for LH Suppression Using a Novel Late-Start Two-Injection Protocol Based on Delayed Initiation of Corifollitropin Alfa
This prospective randomized clinical study evaluates a novel physiology-oriented mild ovarian stimulation protocol based on the delayed initiation of corifollitropin alfa. Unlike conventional ovarian stimulation, which begins during the early follicular phase, the proposed protocol postpones exogenous gonadotropin administration until cycle day 4, allowing physiological follicular recruitment to occur before ovarian stimulation.
Participants are randomly assigned to one of two strategies for prevention of premature luteinizing hormone (LH) surge:
Read more
daily GnRH antagonist administration, or progesterone-primed ovarian stimulation (PPOS). The primary objective is to evaluate ovarian response and the feasibility of this simplified stimulation strategy. Secondary objectives include embryological outcomes, pregnancy outcomes, gonadotropin consumption, treatment burden, and the proportion of patients completing stimulation without supplementary gonadotropin administration.
The study aims to determine whether a physiology-oriented late-start stimulation protocol can simplify IVF treatment while maintaining satisfactory embryological and clinical outcomes.
Read the detailed description
Conventional ovarian stimulation protocols initiate exogenous follicle-stimulating hormone (FSH) administration during the early follicular phase to maximize follicular recruitment. Although effective, this approach may expose follicles to supraphysiological gonadotropin concentrations during the earliest stages of follicular development.
The present study evaluates a novel concept of ovarian stimulation based on delayed administration of 150 μg corifollitropin alfa on cycle day 4. The underlying hypothesis is that endogenous follicular recruitment and early follicular selection should occur under physiological endocrine regulation before exogenous ovarian stimulation is introduced.
Corifollitropin alfa was selected because its prolonged biological activity provides continuous FSH support for approximately seven days following a single administration, making it particularly suitable for this physiology-oriented stimulation concept.
Participants are prospectively randomized to receive either daily GnRH antagonist administration or progesterone-based pituitary suppression (PPOS). Apart from the method of LH suppression, all stimulation procedures, monitoring, ovulation triggering, laboratory procedures, and embryo transfer policies are identical between study groups.The study evaluates ovarian response, embryological outcomes, reproductive outcomes, gonadotropin requirements, and treatment feasibility. A predefined feasibility endpoint, the Single-Injection Completion Rate (SICR), is defined as the proportion of ovarian stimulation cycles successfully completed following a single administration of corifollitropin alfa without supplementary gonadotropin administration.
The study is designed as a proof-of-concept investigation evaluating whether delayed ovarian stimulation based on physiological follicular recruitment can simplify IVF treatment without compromising embryological competence or reproductive outcomes.
- Being tested
- Corifollitropin Alfa 150 μg, GnRH antagonist, Progesterone, Human Menopausal Gonadotropin (hMG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corifollitropin Alfa 150 μgDrug
Also called Elonva 150μg
A single subcutaneous injection of 150 μg corifollitropin alfa administered on the evening of cycle day 4 as part of a late-start mild ovarian stimulation protocol.
GnRH antagonistDrug
Daily GnRH antagonist administration for prevention of premature LH surge according to the study protocol.
ProgesteroneDrug
Oral micronized progesterone is administered daily as part of progesterone-primed ovarian stimulation for the prevention of a premature LH surge. Treatment is continued until ovulation triggering according to the predefined study protocol.
Human Menopausal Gonadotropin (hMG)Drug
Additional hMG (150 IU/day) administered only when predefined clinical criteria are met according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Late-Start Corifollitropin Alfa + GnRH Antagonist | Active comparator | Participants receive oral placebo-free treatment according to the study protocol. On the evening of cycle day 4, a single subcutaneous injection of 150 μg corifollitropin alfa (Elonva®) is administered as part of a late-start mild ovarian stimulation protocol. Premature luteinizing hormone (LH) surge is prevented using daily administration of a GnRH antagonist. Hormonal monitoring and transvaginal ultrasound are performed on cycle day 7.Patients with serum estradiol concentrations ≤1000 pg/mL and/or fewer than two follicles measuring ≥14 mm on cycle day 7 receive supplementary 150 IU/day hMG beginning on cycle day 8 according to the predefined study protocol.Ovulation is triggered with 250 μg recombinant hCG (Ovitrelle®) when at least three follicles reach a mean diameter of 19-20 mm. Receives: Drug: Corifollitropin Alfa 150 μg; Drug: GnRH antagonist; Drug: Human Menopausal Gonadotropin (hMG) |
| Late-Start Corifollitropin Alfa + Progesterone | Experimental | Participants receive a single subcutaneous injection of corifollitropin alfa 150 μg on the evening of cycle day 4. Premature LH surge is prevented using daily oral progesterone as part of a progesterone-primed ovarian stimulation protocol. Patients with serum estradiol concentrations ≤1000 pg/mL and/or fewer than two follicles measuring ≥14 mm on cycle day 7 receive supplementary 150 IU/day hMG beginning on cycle day 8 according to the predefined study protocol. Receives: Drug: Corifollitropin Alfa 150 μg; Drug: Progesterone; Drug: Human Menopausal Gonadotropin (hMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Mature (MII) Oocytes Retrieved per Initiated Stimulation Cycle
The number of mature metaphase II (MII) oocytes obtained following ovarian stimulation, assessed at the time of oocyte retrieval.
The outcome will be expressed as the number of MII oocytes per initiated stimulation cycle. Participants whose cycles are cancelled before oocyte retrieval or who have no mature oocytes retrieved will be assigned a value of zero.
Measured: From initiation of ovarian stimulation through oocyte retrieval, up to 14 days.
Secondary outcomes (12)
Total Number of Oocytes Retrieved per Initiated Stimulation Cycle
The total number of oocytes obtained during transvaginal oocyte retrieval. The outcome will be expressed as the number of retrieved oocytes per initiated stimulation cycle. Participants whose cycles are cancelled before oocyte retrieval or who have no oocytes retrieved will be assigned a value of zero.
Measured: From initiation of ovarian stimulation through oocyte retrieval, up to 14 days.
Oocyte maturation rate
The percentage of retrieved oocytes classified as mature metaphase II (MII) oocytes.
The maturation rate will be calculated as the number of MII oocytes divided by the total number of retrieved oocytes, multiplied by 100.
The analysis will include participants with at least one retrieved oocyte.
Measured: At oocyte retrieval, up to 14 days after initiation of ovarian stimulation.
Normal fertilization rate (2PN)
The percentage of injected mature oocytes demonstrating normal fertilization, defined by the presence of two pronuclei (2PN) following intracytoplasmic sperm injection (ICSI).
The fertilization rate will be calculated as the number of normally fertilized (2PN) oocytes divided by the total number of injected MII oocytes, multiplied by 100.
Measured: At fertilization assessment, 1 day after ICSI.
Blastocyst formation rate
The percentage of normally fertilized (2PN) embryos developing into blastocysts by day 6 of embryo culture.
The blastocyst formation rate will be calculated as the total number of blastocysts formed by day 6 divided by the number of normally fertilized (2PN) oocytes, multiplied by 100.
Measured: From fertilization through day 6 of embryo culture.
Number of Usable Blastocysts per Oocyte Retrieval
The total number of blastocysts considered suitable for embryo transfer or cryopreservation according to predefined laboratory morphological assessment criteria.
Blastocysts will be assessed on days 5 and 6 of embryo culture.
Measured: From fertilization through day 6 of embryo culture.
Total Supplementary Gonadotropin Consumption
The cumulative dose of supplementary human menopausal gonadotropin (hMG) administered during ovarian stimulation, expressed in International Units (IU).
Supplementary hMG may be administered at a dose of 150 IU daily from cycle day 8 according to predefined hormonal and ultrasonographic response criteria.
Participants who do not require supplementary hMG will be assigned a value of zero.
The initial administration of 150 μg corifollitropin alfa will not be included in the calculation of supplementary hMG consumption.
Measured: From initiation of ovarian stimulation through ovulation triggering or cycle cancellation, up to 14 days.
Clinical Pregnancy Rate per Embryo Transfer
The percentage of embryo transfer procedures resulting in clinical pregnancy. Clinical pregnancy is defined as ultrasonographic confirmation of at least one intrauterine gestational sac with fetal cardiac activity.
All fresh and frozen embryo transfers involving embryos derived from the study stimulation cycle and performed within 6 months after oocyte retrieval will be included.
The clinical pregnancy rate will be calculated as the number of embryo transfer procedures resulting in clinical pregnancy divided by the total number of embryo transfer procedures performed within the specified follow-up period, multiplied by 100.
Measured: From oocyte retrieval through clinical pregnancy assessment, up to 9 months.
Ongoing Pregnancy Rate per Embryo Transfer
The percentage of embryo transfer procedures resulting in an ongoing pregnancy. Ongoing pregnancy is defined as the presence of a viable intrauterine pregnancy with fetal cardiac activity at 12 completed weeks of gestation.
All fresh and frozen embryo transfers involving embryos derived from the study stimulation cycle and performed within 6 months after oocyte retrieval will be included.
The ongoing pregnancy rate will be calculated as the number of embryo transfer procedures resulting in ongoing pregnancy divided by the total number of embryo transfer procedures performed within the specified follow-up period, multiplied by 100.
Measured: From oocyte retrieval through ongoing pregnancy assessment, up to 10 months.
Live Birth Rate per Embryo Transfer
The percentage of embryo transfer procedures resulting in the delivery of at least one live-born infant.
Live birth is defined as the complete expulsion or extraction of a fetus from the mother, irrespective of gestational age, showing evidence of life after birth.
All fresh and frozen embryo transfers involving embryos derived from the study stimulation cycle and performed within 6 months after oocyte retrieval will be included.
Multiple live-born infants resulting from a single embryo transfer procedure will be counted as one live birth event.
The live birth rate will be calculated as the number of embryo transfer procedures resulting in at least one live birth divided by the total number of embryo transfer procedures performed within the specified follow-up period, multiplied by 100.
Measured: From oocyte retrieval through delivery, up to 18 months.
Single-Injection Completion Rate (SICR)
The percentage of participants completing ovarian stimulation using a single subcutaneous injection of 150 μg corifollitropin alfa without requiring supplementary gonadotropin administration.
Successful single-injection completion is defined as reaching ovulation triggering without supplementary hMG or other gonadotropin administration.
The rate will be calculated as the number of participants achieving single-injection completion divided by the total number of participants who initiated ovarian stimulation, multiplied by 100.
Measured: From initiation of ovarian stimulation through ovulation triggering or cycle cancellation, up to 14 days.
Requirement for Supplementary hMG Administration
The percentage of participants requiring supplementary human menopausal gonadotropin (hMG) following the initial administration of 150 μg corifollitropin alfa.
Supplementary hMG is administered from cycle day 8 when predefined hormonal and ultrasonographic criteria for continuation without additional gonadotropins are not fulfilled.
The rate will be calculated as the number of participants receiving at least one supplementary hMG injection divided by the total number of participants who initiated ovarian stimulation, multiplied by 100.
Measured: From initiation of ovarian stimulation through ovulation triggering or cycle cancellation, up to 14 days.
Cumulative Live Birth Rate per Initiated Stimulation Cycle
The percentage of initiated ovarian stimulation cycles resulting in at least one live birth following the transfer of embryos derived from the corresponding stimulation cycle.
All fresh and frozen embryo transfers performed within 6 months after oocyte retrieval will be included.
Each initiated stimulation cycle will be counted only once, regardless of the number of embryo transfers performed or the number of live-born infants.
The cumulative live birth rate will be calculated as the number of initiated stimulation cycles resulting in at least one live birth divided by the total number of initiated stimulation cycles, multiplied by 100.
Measured: From initiation of ovarian stimulation through delivery, up to 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Jan 2024
- Primary completion1 May 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertile Patient Undergoing ICSI ProcedureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assisting Nature
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Najdecki, PhD, Study director, Assisting Nature Fertility and Genetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891793
- Sponsor's protocol ID
- 0101241811
- Acronym
- two injection
- Status last verified
- Oct 2026
- First submitted
- 27 Jul 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: we not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiology-Oriented Mild Ovarian Stimulation: A Randomized Prospective Comparison of Two Strategies for LH Suppression Using a Novel Late-Start Two-Injection Protocol Based on Delayed Initiation of Corifollitropin Alfa
- ClinicalTrials.gov ID
- NCT07891793
- Acronym / sponsor ID
- two injection / 0101241811
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Assisting NatureUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 23 Oct 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 randomized clinical study evaluates a novel physiology-oriented mild ovarian stimulation protocol based on the delayed initiation of corifollitropin alfa. Unlike conventional ovarian stimulation, which begins during the early follicular phase, the proposed protocol postpones exogenous gonadotropin administration until cycle day 4, allowing physiological follicular recruitment to occur before ovarian stimulation.
Participants are randomly assigned to one of two strategies for prevention of premature luteinizing hormone (LH) surge:
daily GnRH antagonist administration, or progesterone-primed ovarian stimulation (PPOS). The primary objective is to evaluate ovarian response and the feasibility of this simplified stimulation strategy. Secondary objectives include embryological outcomes, pregnancy outcomes, gonadotropin consumption, treatment burden, and the proportion of patients completing stimulation without supplementary gonadotropin administration.
The study aims to determine whether a physiology-oriented late-start stimulation protocol can simplify IVF treatment while maintaining satisfactory embryological and clinical outcomes.
Detailed description
Conventional ovarian stimulation protocols initiate exogenous follicle-stimulating hormone (FSH) administration during the early follicular phase to maximize follicular recruitment. Although effective, this approach may expose follicles to supraphysiological gonadotropin concentrations during the earliest stages of follicular development.
The present study evaluates a novel concept of ovarian stimulation based on delayed administration of 150 μg corifollitropin alfa on cycle day 4. The underlying hypothesis is that endogenous follicular recruitment and early follicular selection should occur under physiological endocrine regulation before exogenous ovarian stimulation is introduced.
Corifollitropin alfa was selected because its prolonged biological activity provides continuous FSH support for approximately seven days following a single administration, making it particularly suitable for this physiology-oriented stimulation concept.
Participants are prospectively randomized to receive either daily GnRH antagonist administration or progesterone-based pituitary suppression (PPOS). Apart from the method of LH suppression, all stimulation procedures, monitoring, ovulation triggering, laboratory procedures, and embryo transfer policies are identical between study groups.The study evaluates ovarian response, embryological outcomes, reproductive outcomes, gonadotropin requirements, and treatment feasibility. A predefined feasibility endpoint, the Single-Injection Completion Rate (SICR), is defined as the proportion of ovarian stimulation cycles successfully completed following a single administration of corifollitropin alfa without supplementary gonadotropin administration.
The study is designed as a proof-of-concept investigation evaluating whether delayed ovarian stimulation based on physiological follicular recruitment can simplify IVF treatment without compromising embryological competence or reproductive outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Late-Start Corifollitropin Alfa + GnRH Antagonist | Active comparator | Drug: Corifollitropin Alfa 150 μg, Drug: GnRH antagonist, Drug: Human Menopausal Gonadotropin (hMG)Participants receive oral placebo-free treatment according to the study protocol. On the evening of cycle day 4, a single subcutaneous injection of 150 μg corifollitropin alfa (Elonva®) is administered as part of a late-start mild ovarian stimulation protocol. Premature luteinizing hormone (LH) surge is prevented using daily administration of a GnRH antagonist. Hormonal monitoring and transvaginal ultrasound are performed on cycle day 7.Patients with serum estradiol concentrations ≤1000 pg/mL and/or fewer than two follicles measuring ≥14 mm on cycle day 7 receive supplementary 150 IU/day hMG beginning on cycle day 8 according to the predefined study protocol.Ovulation is triggered with 250 μg recombinant hCG (Ovitrelle®) when at least three follicles reach a mean diameter of 19-20 mm. |
| Late-Start Corifollitropin Alfa + Progesterone | Experimental | Drug: Corifollitropin Alfa 150 μg, Drug: Progesterone, Drug: Human Menopausal Gonadotropin (hMG)Participants receive a single subcutaneous injection of corifollitropin alfa 150 μg on the evening of cycle day 4. Premature LH surge is prevented using daily oral progesterone as part of a progesterone-primed ovarian stimulation protocol. Patients with serum estradiol concentrations ≤1000 pg/mL and/or fewer than two follicles measuring ≥14 mm on cycle day 7 receive supplementary 150 IU/day hMG beginning on cycle day 8 according to the predefined study protocol. |
Who may qualify
- Ages
- 28 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female participants aged 28 to 43 years at the time of enrollment.
- Clinical diagnosis of infertility requiring IVF or ICSI treatment.
- Planned controlled ovarian stimulation according to the study protocol.
- Anti-Müllerian hormone concentration of 0.2 ng/mL or greater.
- Presence of both ovaries.
Key exclusion criteria (8 listed)
- Age younger than 28 years or older than 43 years.
- Anti-Müllerian hormone concentration below 0.2 ng/mL.
- Untreated endocrine disorders that may interfere with ovarian stimulation, including uncontrolled thyroid disease or hyperprolactinemia.
- Contraindication to ovarian stimulation, pregnancy, or transvaginal oocyte retrieval.
- Severe systemic disease considered by the investigator to make participation unsafe.
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 |
|---|---|---|
| Corifollitropin Alfa 150 μgAlso: Elonva 150μgA single subcutaneous injection of 150 μg corifollitropin alfa administered on the evening of cycle day 4 as part of a late-start mild ovarian stimulation protocol. | Drug | Late-Start Corifollitropin Alfa + GnRH Antagonist, Late-Start Corifollitropin Alfa + Progesterone |
| GnRH antagonistDaily GnRH antagonist administration for prevention of premature LH surge according to the study protocol. | Drug | Late-Start Corifollitropin Alfa + GnRH Antagonist |
| ProgesteroneOral micronized progesterone is administered daily as part of progesterone-primed ovarian stimulation for the prevention of a premature LH surge. Treatment is continued until ovulation triggering according to the predefined study protocol. | Drug | Late-Start Corifollitropin Alfa + Progesterone |
| Human Menopausal Gonadotropin (hMG)Additional hMG (150 IU/day) administered only when predefined clinical criteria are met according to the study protocol. | Drug | Late-Start Corifollitropin Alfa + GnRH Antagonist, Late-Start Corifollitropin Alfa + Progesterone |
Primary outcome
Number of Mature (MII) Oocytes Retrieved per Initiated Stimulation Cycle
Time frame: From initiation of ovarian stimulation through oocyte retrieval, up to 14 days.
The number of mature metaphase II (MII) oocytes obtained following ovarian stimulation, assessed at the time of oocyte retrieval. The outcome will be expressed as the number of MII oocytes per initiated stimulation cycle. Participants whose cycles are cancelled before oocyte retrieval or who have no mature oocytes retrieved will be assigned a value of zero.
12 secondary outcomes
Total Number of Oocytes Retrieved per Initiated Stimulation Cycle
Time frame: From initiation of ovarian stimulation through oocyte retrieval, up to 14 days.
Oocyte maturation rate
Time frame: At oocyte retrieval, up to 14 days after initiation of ovarian stimulation.
Normal fertilization rate (2PN)
Time frame: At fertilization assessment, 1 day after ICSI.
Blastocyst formation rate
Time frame: From fertilization through day 6 of embryo culture.
Number of Usable Blastocysts per Oocyte Retrieval
Time frame: From fertilization through day 6 of embryo culture.
Total Supplementary Gonadotropin Consumption
Time frame: From initiation of ovarian stimulation through ovulation triggering or cycle cancellation, up to 14 days.
Clinical Pregnancy Rate per Embryo Transfer
Time frame: From oocyte retrieval through clinical pregnancy assessment, up to 9 months.
Ongoing Pregnancy Rate per Embryo Transfer
Time frame: From oocyte retrieval through ongoing pregnancy assessment, up to 10 months.
Live Birth Rate per Embryo Transfer
Time frame: From oocyte retrieval through delivery, up to 18 months.
Single-Injection Completion Rate (SICR)
Time frame: From initiation of ovarian stimulation through ovulation triggering or cycle cancellation, up to 14 days.
Requirement for Supplementary hMG Administration
Time frame: From initiation of ovarian stimulation through ovulation triggering or cycle cancellation, up to 14 days.
Cumulative Live Birth Rate per Initiated Stimulation Cycle
Time frame: From initiation of ovarian stimulation through delivery, up to 18 months.
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 23 Oct 2026.
- Individual participant dataSharing planned: Undecided. we not decided yet
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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.
Robert Najdecki, PhD study director
Assisting Nature Fertility and Genetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corifollitropin Alfa 150 μg, GnRH antagonist and Progesterone in people with Infertile Patient Undergoing ICSI Procedure, run by Assisting Nature at 1 site in Greece.
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 7 inclusion and 8 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 23 Oct 2026. 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 Greece. 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?
Number of Mature (MII) Oocytes Retrieved per Initiated Stimulation Cycle (time frame: From initiation of ovarian stimulation through oocyte retrieval, up to 14 days.). 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 Oct 2026.