InfertilityTBCNCT03686852
Effect of Recombinant Follicular Stimulating Hormone (FSH) Dosing Following Cori-follitropin Alfa
A study testing same medications but different dosages in people with Infertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
In the trial, women planned to be treated with 150μg corifollitropin alfa followed by rFSH in a fixed GnRH antagonist protocol will be asked to participate and sign the ICF. Corifollitropin alpha treatment will be initiated at D2-D3 of the cycle. 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?
- same medications but different dosages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2019to 31 Jan 2024
- 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 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female age: > 18 to < 38 years
- The patient must have undergone not more than three consecutive unsuccessful IVF/ICSI cycles since the last ongoing pregnancy (whether fresh and/or several frozen ET resulted from these attempts)
- BMI ≤29 Kg /m2
- Patients of ≤ 35 years old, body weight should be ≥ 60kg
- Patients of >35 years old, body weight should be > 50 kg
- Regular normo-ovulatory menstrual cycles (26-35 days)
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- Basal FSH <10 IU/l, basal E2 <60 pg/ml and basal Progesteone (< 1.5 ng/mL) (normal cycle day-3 basal serum hormone levels), to be measured on cycle day 2 or 3 of the treatment cycle
- Normal ultrasound scan (presence of both ovaries without evidence of abnormality within 6 months)
- AFC >7 and < 20
- No pill within the 3 months before treatment
- Signed informed consent
Who cannot join
- Polycystic ovarian syndrome (PCOS) according to the Rotterdam classification (2004)
- Oocyte donors
- Poor responder patients (development of <4 follicles in previous IVF/ICSI or cancelled cycles)
- Endometriosis ≥ grade 3
- Contraindications to the use of gonadotropins
- Abnormal vaginal bleeding of unknown cause
- History of ovarian hyperstimulation syndrome (OHSS) or a previous ovarian stimulation cycle with more than 30 follicles of 11 mm or higher (as recommended by the Elonva® Summary of Product Characteristics)
- A history of recurrent miscarriage (three or more consecutive miscarriages)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Recombinant FSH Dosing Following Cori-follitropin Alfa in Patients Undergoing in Vitro Fertilization/Intra-citoplasmatic Sperm Injection: a Randomized Controlled Dose-finding Study.
In the trial, women planned to be treated with 150μg corifollitropin alfa followed by rFSH in a fixed GnRH antagonist protocol will be asked to participate and sign the ICF. Corifollitropin alpha treatment will be initiated at D2-D3 of the cycle. Patients who need additional r-FSH following corifollitropin-alfa will be randomized on day 8 of the stimulation into 3 study groups. In group A, B and C, ovarian stimulation with Corifollitropin alfa (Elonva®, MSD) will be used for ovarian stimulation, followed by 50IU (Group A), 150IU (Group B) or 250IU (Group C) of recFSH (Puregon®, MSD).
Read the detailed description
On day 2 or on day 3 of the cycle, blood sampling for estradiol (E2), progesterone (P), follicle stimulating hormone (FSH), luteinising hormone (LH) and human chorionic gonadotropin (hCG) levels, will be per-formed prior to the administration of corifollitropin alfa.
All the blood samples taken during the stimulation for the hormonal profile, starting from day 2, will be performed in a double tube, one for a central assessment and one for the local assessment in order to be used during the monitoring of the cycle. AMH will also be assess on day 2 of the stimulation with a blood sample that will be sent for central assessment.
Administration of the GnRH antagonist ganirelix (Orgalutran®, MSD) will be initiated on day 6 of stimula-tion in all treatment arms at a daily dose of 0.25 mg to prevent a premature LH surge. Suppression with the GnRH antagonist will be continued until the day of final oocyte maturation. Endocrine monitoring and ultrasound scan will be carried out on day 8 of stimulation and repeated every two days until trigger, de-pending on the patients' response. Triggering for final oocyte maturation is performed as soon as 3 follicles of ≥17 mm will be observed.
Cycles will be cancelled if less than 3 follicles of 12 mm are observed on day 8 day of stimulation, nonethe-less, blood test for hormonal evaluation will be performed in any case on day 8.
Oocyte maturation will be triggered with a single subcutaneous injection of hCG (Pregnyl®: 5000UI/sc, MSD, or 10000UI/sc if body weight exceeds 80 kg) as soon as 3 follicles of ≥17 mm will be observed. Ap-proximately 34-36 hours after trigger, oocyte retrieval will be performed. An embryo transfer will be per-formed on day 3 or on day 5 of embryonic development; one or 2 embryos will be replaced.
The luteal phase will be supported by vaginal administration of micronized progesterone 600 mg/day (Utrogestan®) from the day after ovarian puncture until the day of pregnancy test. In case of pregnancy, progesterone administration will be extended until week 7. In case of risk of OHSS, namely the presence of >18 follicles of 11 mm or more, final oocyte maturation will be triggered with a GnRH agonist (Gonapep-tyl, 0.2 mg) and a freeze-all strategy will be applied (Papanikolaou et al., 2006, Griesinger et al., 2016). A freeze -all strategy will also be applied in case of P>1.5 ng/mL on the day of hCG and per clinician prefer-ence.
All the patients will be asked to inject CFA and rFSH between 6-10 PM; the antagonist injection (ganirelix) will be performed between 7-11 AM and the endocrine profile measurements, alias blood tests, will be done between 7 and 11 AM.
- Conditions
- Infertility
- Being tested
- same medications but different dosages
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
same medications but different dosagesOther
The main difference between the groups is due to the different dose of r-FSH which will be given to pa-tients after the 7 days of CFA; namely that patients who need additional r-FSH following corifollitropin-alfa will be randomized on day 8 of the stimulation into 3 study groups. In group A, B and C, ovarian stimula-tion with Corifollitropin alfa (Elonva®, MSD) will be used for ovarian stimulation, followed by 50IU (Group A), 150IU (Group B) or 250IU (Group C) of recFSH (Puregon®, MSD)
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | The main difference between the groups is due to the different dose of r-FSH which will be given to pa-tients after the 7 days of CFA; namely that patients who need additional r-FSH following corifollitropin-alfa will be randomized on day 8 of the stimulation into 3 study groups. In group A, B and C, ovarian stimula-tion with Corifollitropin alfa (Elonva®, MSD) will be used for ovarian stimulation, followed by 50IU (Group A). Receives: Other: same medications but different dosages |
| groppo B | Active comparator | The main difference between the groups is due to the different dose of r-FSH which will be given to pa-tients after the 7 days of CFA; namely that patients who need additional r-FSH following corifollitropin-alfa will be randomized on day 8 of the stimulation into 3 study groups. In group A, B and C, ovarian stimula-tion with Corifollitropin alfa (Elonva®, MSD) will be used for ovarian stimulation, followed by 150IU (Group B) Receives: Other: same medications but different dosages |
| Group C | Active comparator | The main difference between the groups is due to the different dose of r-FSH which will be given to pa-tients after the 7 days of CFA; namely that patients who need additional r-FSH following corifollitropin-alfa will be randomized on day 8 of the stimulation into 3 study groups. In group A, B and C, ovarian stimula-tion with Corifollitropin alfa (Elonva®, MSD) will be used for ovarian stimulation, followed by 250IU (Group C) of recFSH (Puregon®, MSD). Receives: Other: same medications but different dosages |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum progesterone level on the day of the trigger
Compare the mean serum progesterone level (ng/mL) on day of hCG between the study groups.
Measured: 2 years
Secondary outcomes (4)
Number of oocytes retrieved
number of oocytes retrieved the day of the pick up
Measured: 2 years
Number of patients who underwent freeze all the embryos (FA)
number of patients who need to avoid the fresh embryo transfer (ET) and do a freeze all procedure.
Measured: 2 years
Clinical pregnancy rate
The number of clinical pregnancies expressed per 100 initiated cycles, aspiration cycles or embryo transfer cycles. When clinical pregnancy rates are recorded, the denominator (initiated, aspirated or embryo transfer cycles) must be specified.
Measured: 2 years
Miscarriage rate
Spontaneous loss of a clinical pregnancy before 22 completed weeks of gestational age, in which the embryo(s) or fetus(es) is/are nonviable and is/are not spontaneously absorbed or expelled from the uterus.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start1 May 2019
- Primary completion1 Aug 2023
- Study completion31 Jan 2024
Why it stopped: Slow recruitment
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 Universitair Ziekenhuis BrusselThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- AZ Jan Palfijn Gent, Erasme University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686852
- Sponsor's protocol ID
- rFSHdosingfinding.2018
- Acronym
- TBC
- Status last verified
- Dec 2023
- First submitted
- 25 Sep 2018
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Recombinant FSH Dosing Following Cori-follitropin Alfa in Patients Undergoing in Vitro Fertilization/Intra-citoplasmatic Sperm Injection: a Randomized Controlled Dose-finding Study.
- ClinicalTrials.gov ID
- NCT03686852
- Acronym / sponsor ID
- TBC / rFSHdosingfinding.2018
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- AZ Jan Palfijn Gent, Erasme University Hospital
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 27 Sep 2018 (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.
In the trial, women planned to be treated with 150μg corifollitropin alfa followed by rFSH in a fixed GnRH antagonist protocol will be asked to participate and sign the ICF. Corifollitropin alpha treatment will be initiated at D2-D3 of the cycle. Patients who need additional r-FSH following corifollitropin-alfa will be randomized on day 8 of the stimulation into 3 study groups. In group A, B and C, ovarian stimulation with Corifollitropin alfa (Elonva®, MSD) will be used for ovarian stimulation, followed by 50IU (Group A), 150IU (Group B) or 250IU (Group C) of recFSH (Puregon®, MSD).
Detailed description
On day 2 or on day 3 of the cycle, blood sampling for estradiol (E2), progesterone (P), follicle stimulating hormone (FSH), luteinising hormone (LH) and human chorionic gonadotropin (hCG) levels, will be per-formed prior to the administration of corifollitropin alfa.
All the blood samples taken during the stimulation for the hormonal profile, starting from day 2, will be performed in a double tube, one for a central assessment and one for the local assessment in order to be used during the monitoring of the cycle. AMH will also be assess on day 2 of the stimulation with a blood sample that will be sent for central assessment.
Administration of the GnRH antagonist ganirelix (Orgalutran®, MSD) will be initiated on day 6 of stimula-tion in all treatment arms at a daily dose of 0.25 mg to prevent a premature LH surge. Suppression with the GnRH antagonist will be continued until the day of final oocyte maturation. Endocrine monitoring and ultrasound scan will be carried out on day 8 of stimulation and repeated every two days until trigger, de-pending on the patients' response. Triggering for final oocyte maturation is performed as soon as 3 follicles of ≥17 mm will be observed.
Cycles will be cancelled if less than 3 follicles of 12 mm are observed on day 8 day of stimulation, nonethe-less, blood test for hormonal evaluation will be performed in any case on day 8.
Oocyte maturation will be triggered with a single subcutaneous injection of hCG (Pregnyl®: 5000UI/sc, MSD, or 10000UI/sc if body weight exceeds 80 kg) as soon as 3 follicles of ≥17 mm will be observed. Ap-proximately 34-36 hours after trigger, oocyte retrieval will be performed. An embryo transfer will be per-formed on day 3 or on day 5 of embryonic development; one or 2 embryos will be replaced.
The luteal phase will be supported by vaginal administration of micronized progesterone 600 mg/day (Utrogestan®) from the day after ovarian puncture until the day of pregnancy test. In case of pregnancy, progesterone administration will be extended until week 7. In case of risk of OHSS, namely the presence of >18 follicles of 11 mm or more, final oocyte maturation will be triggered with a GnRH agonist (Gonapep-tyl, 0.2 mg) and a freeze-all strategy will be applied (Papanikolaou et al., 2006, Griesinger et al., 2016). A freeze -all strategy will also be applied in case of P>1.5 ng/mL on the day of hCG and per clinician prefer-ence.
All the patients will be asked to inject CFA and rFSH between 6-10 PM; the antagonist injection (ganirelix) will be performed between 7-11 AM and the endocrine profile measurements, alias blood tests, will be done between 7 and 11 AM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Other: same medications but different dosagesThe main difference between the groups is due to the different dose of r-FSH which will be given to pa-tients after the 7 days of CFA; namely that patients who need additional r-FSH following corifollitropin-alfa will be randomized on day 8 of the stimulation into 3 study groups. In group A, B and C, ovarian stimula-tion with Corifollitropin alfa (Elonva®, MSD) will be used for ovarian stimulation, followed by 50IU (Group A). |
| groppo B | Active comparator | Other: same medications but different dosagesThe main difference between the groups is due to the different dose of r-FSH which will be given to pa-tients after the 7 days of CFA; namely that patients who need additional r-FSH following corifollitropin-alfa will be randomized on day 8 of the stimulation into 3 study groups. In group A, B and C, ovarian stimula-tion with Corifollitropin alfa (Elonva®, MSD) will be used for ovarian stimulation, followed by 150IU (Group B) |
| Group C | Active comparator | Other: same medications but different dosagesThe main difference between the groups is due to the different dose of r-FSH which will be given to pa-tients after the 7 days of CFA; namely that patients who need additional r-FSH following corifollitropin-alfa will be randomized on day 8 of the stimulation into 3 study groups. In group A, B and C, ovarian stimula-tion with Corifollitropin alfa (Elonva®, MSD) will be used for ovarian stimulation, followed by 250IU (Group C) of recFSH (Puregon®, MSD). |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Female age: > 18 to < 38 years
- The patient must have undergone not more than three consecutive unsuccessful IVF/ICSI cycles since the last ongoing pregnancy (whether fresh and/or several frozen ET resulted from these attempts)
- BMI ≤29 Kg /m2
- Patients of ≤ 35 years old, body weight should be ≥ 60kg
- Patients of >35 years old, body weight should be > 50 kg
Key exclusion criteria (8 listed)
- Polycystic ovarian syndrome (PCOS) according to the Rotterdam classification (2004)
- Oocyte donors
- Poor responder patients (development of <4 follicles in previous IVF/ICSI or cancelled cycles)
- Endometriosis ≥ grade 3
- Contraindications to the use of gonadotropins
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 |
|---|---|---|
| same medications but different dosagesThe main difference between the groups is due to the different dose of r-FSH which will be given to pa-tients after the 7 days of CFA; namely that patients who need additional r-FSH following corifollitropin-alfa will be randomized on day 8 of the stimulation into 3 study groups. In group A, B and C, ovarian stimula-tion with Corifollitropin alfa (Elonva®, MSD) will be used for ovarian stimulation, followed by 50IU (Group A), 150IU (Group B) or 250IU (Group C) of recFSH (Puregon®, MSD) | Other | Group C, groppo B, group A |
Primary outcome
serum progesterone level on the day of the trigger
Time frame: 2 years
Compare the mean serum progesterone level (ng/mL) on day of hCG between the study groups.
4 secondary outcomes
Number of oocytes retrieved
Time frame: 2 years
Number of patients who underwent freeze all the embryos (FA)
Time frame: 2 years
Clinical pregnancy rate
Time frame: 2 years
Miscarriage rate
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing same medications but different dosages in people with Infertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 11 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: stopped early, as of the sponsor's last update on 13 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 Belgium. 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 was stopped early (reason given: Slow recruitment). Results are not available in the source record.
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?
serum progesterone level on the day of the trigger (time frame: 2 years). 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 13 Oct 2026.