IVFPhase 2REKO15NCT04778358
Higher Dose of Rekovelle in Oocyte Donors
A Phase 2 study testing Follitropin Delta, Recombinant in people with IVF, run by IVI Madrid at 1 site in Spain.
Trial summary
Higher numbers of oocytes have not been shown to increase implantation or live newborn rates, but higher numbers of oocytes are likely to be beneficial in certain treatments. These clinical cases where a high ovarian response can be IVF cycles with genetic diagnosis, patients who need more than one pregnancy or, as in… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IVF
- What is being tested?
- Follitropin Delta, Recombinant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 28 Sep 2021to 16 Jun 2022
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who meet the following inclusion criteria will be candidates to participate in the trial.
- Signed and dated informed consent.
- Oocyte donors between 18 and 35 years of age, both inclusive.
- Presence of at least 6 antral follicles in each ovary on the day of start of stimulation.
- Oocyte donors in their first or second donation cycle.
Who cannot join
- Patients who meet the following criteria will not be able to participate in the clinical trial:
- Simultaneous participation in another clinical trial
- Participation in another clinical study before inclusion in this study that could affect its objectives.
- Donors diagnosed with polycystic ovary syndrome according to the Rotterdam criteria (4)
- Endometriosis level III / IV
- Use of hormonal contraceptives (oral or vaginal) in the cycle prior to inclusion.
Show all 10Show fewer
- Use of Estradiol Valerate for cycle synchronization in the cycle prior to inclusion.
- Family history of hereditary diseases
- Presence of abnormal karyotype
- Positive for any sexually transmitted disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Trial to Investigate a Higher Dose of Rekovelle in Oocyte Donors
Higher numbers of oocytes have not been shown to increase implantation or live newborn rates, but higher numbers of oocytes are likely to be beneficial in certain treatments. These clinical cases where a high ovarian response can be IVF cycles with genetic diagnosis, patients who need more than one pregnancy or, as in our case, oocyte donation. For this reason, and based on previous studies, investigators intend to increase the ovarian response by increasing the dose of follitropin. This clinical trial aims to evaluate high doses of Rekovelle (follitropin delta) to obtain an average of 17 oocytes in a population of oocyte donors, without affecting the health of the patients.
Read the detailed description
IVF ovarian stimulation cycles has been shown that the individualization of the medication doses provides clinical results comparable to conventional ovarian stimulation regimens, but also it results in greater treatment safety by significantly reducing the percentage of patients with responses extreme ovaries, and cycle cancellations. These studies have been carried out with the premise that an optimal ovarian response results in obtaining 8-14 oocytes per puncture. Although it has also been shown that larger numbers of oocytes do not increase clinical variables such as implantation rates or live newborn per cycle, it is possible that these numbers of oocytes are insufficient in specific circumstances, for example, patients with a desire to have more pregnancy, patients undergoing IVF cycles with PGT-A, or gamete donors. For these reasons, and thanks to the improvements in cryopreservation programs and the induction of oocyte maturation with GnRH agonists, it is necessary to design protocols for the individualization of doses of medication aimed at obtaining greater quantities of oocytes. The objective of this pilot study is the evaluation of higher doses of Rekovelle (follitropin delta) aimed at obtaining 17 oocytes in voluntary donors.
- Conditions
- IVF
- Being tested
- Follitropin Delta, Recombinant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follitropin Delta, RecombinantDrug
15 µg of follitropin delta will be administered subcutaneously daily
| Study group | Role | What they receive |
|---|---|---|
| OOCYTE DONORS | Experimental | Administration of a higher dose of Rekovelle (follitropin delta) to increase the ovarian response to 17 oocytes (the optimal range being 15 to 25 oocytes) in an oocyte donor population without compromising safety and efficacy. Receives: Drug: Follitropin Delta, Recombinant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assest the dose of 15µg of follitropin delta aimed at obtaining 17 oocytes (considering the optimal range of oocytes from 15 to 25).
To evaluate the number of oocytes of a fixed dose of 15µg of the drug Rekovelle (follitropin delta) during the entire stimulation of oocyte donors aimed at obtaining 17 oocytes (considering the optimal range of oocytes from 15 to 25).
Measured: Number of oocytes obtained inmediatly after the ovarian puncture in visit 5
Measure the incidence of ovarian hyperstimulation syndrome using15µg of follitropin delta aimed at obtaining 17 oocytes
Evaluate with a GOLAN scale.
Golan classification:
Classify early or late ovarian hyperstimulation syndrome, according to clinic, ultrasound and laboratory tests
Mild ovarian hyperstimulation:
- Grade 1 Abdominal discomfort and bloating
- Grade 2 Grade 1 + nausea, vomiting, or diarrhea. Ovaries enlarged 5-12 cm in ø
Moderate Hyperstimulation:
- Grade 3 Grade 2 + ultrasound signs of ascites
Severe hyperstimulation:
- Grade 4 Grade 3 + clinical ascites, respiratory distress, hydrothorax
- Grade 5 Grade 4 and hemoconcentration, hypovolemia, impaired coagulation and renal function (oligo / anuria)
Measured: Through the study completion, an average 1 month.
Secondary outcomes (5)
Number of mature oocytes
Evaluate the number of mature oocyte
Measured: Number of madure oocytes obtained inmediatly after the puncture in visit 5
Duration of stimulation in days
Evaluate the duration of stimulation in days
Measured: Number of days during the ovarian stimulation up to 20 days
Number of blasts
Early stage of embryonic development that appears 4-6 days after fertilization and before implantation in the endometrium
Measured: 4-6 days after fertilization and before implantation in the endometrium during the treatment.
Blast quality
Blast quality according to the Gardner scale, classification of blastocysts, where in addition to the structure of the inner cell mass (ICM) and cells of the trophectoderm, it provides a degree of expansion
Measured: 4-6 days after fertilization and before implantation in the endometrium during the treatment.
Degree of satisfaction with the infertility treatment
Degree of satisfaction with the infertility treatment according to the EFESO, Questionnaire designed to know the degree of satisfaction of women who undergo ovarian stimulation treatment to treat their infertility questionnaire
Measured: At the end of the treatment, an average 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start28 Sep 2021
- Primary completion16 Jun 2022
- Study completion16 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Oocyte donors
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778358
- Sponsor's protocol ID
- 1901-MAD-013-JG
- Acronym
- REKO15
- Status last verified
- Nov 2022
- First submitted
- 28 Jan 2021
- Last updated
- 14 Nov 2022
- 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 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial to Investigate a Higher Dose of Rekovelle in Oocyte Donors
- ClinicalTrials.gov ID
- NCT04778358
- Acronym / sponsor ID
- REKO15 / 1901-MAD-013-JG
- Conditions
- IVF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 3 Mar 2021 (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.
Higher numbers of oocytes have not been shown to increase implantation or live newborn rates, but higher numbers of oocytes are likely to be beneficial in certain treatments. These clinical cases where a high ovarian response can be IVF cycles with genetic diagnosis, patients who need more than one pregnancy or, as in our case, oocyte donation. For this reason, and based on previous studies, investigators intend to increase the ovarian response by increasing the dose of follitropin. This clinical trial aims to evaluate high doses of Rekovelle (follitropin delta) to obtain an average of 17 oocytes in a population of oocyte donors, without affecting the health of the patients.
Detailed description
IVF ovarian stimulation cycles has been shown that the individualization of the medication doses provides clinical results comparable to conventional ovarian stimulation regimens, but also it results in greater treatment safety by significantly reducing the percentage of patients with responses extreme ovaries, and cycle cancellations. These studies have been carried out with the premise that an optimal ovarian response results in obtaining 8-14 oocytes per puncture. Although it has also been shown that larger numbers of oocytes do not increase clinical variables such as implantation rates or live newborn per cycle, it is possible that these numbers of oocytes are insufficient in specific circumstances, for example, patients with a desire to have more pregnancy, patients undergoing IVF cycles with PGT-A, or gamete donors. For these reasons, and thanks to the improvements in cryopreservation programs and the induction of oocyte maturation with GnRH agonists, it is necessary to design protocols for the individualization of doses of medication aimed at obtaining greater quantities of oocytes. The objective of this pilot study is the evaluation of higher doses of Rekovelle (follitropin delta) aimed at obtaining 17 oocytes in voluntary donors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Oocyte donors
| Arm | Type | Receives |
|---|---|---|
| OOCYTE DONORS | Experimental | Drug: Follitropin Delta, RecombinantAdministration of a higher dose of Rekovelle (follitropin delta) to increase the ovarian response to 17 oocytes (the optimal range being 15 to 25 oocytes) in an oocyte donor population without compromising safety and efficacy. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who meet the following inclusion criteria will be candidates to participate in the trial.
- Signed and dated informed consent.
- Oocyte donors between 18 and 35 years of age, both inclusive.
- Presence of at least 6 antral follicles in each ovary on the day of start of stimulation.
- Oocyte donors in their first or second donation cycle.
Key exclusion criteria (10 listed)
- Patients who meet the following criteria will not be able to participate in the clinical trial:
- Simultaneous participation in another clinical trial
- Participation in another clinical study before inclusion in this study that could affect its objectives.
- Donors diagnosed with polycystic ovary syndrome according to the Rotterdam criteria (4)
- Endometriosis level III / IV
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 |
|---|---|---|
| Follitropin Delta, Recombinant15 µg of follitropin delta will be administered subcutaneously daily | Drug | OOCYTE DONORS |
Primary outcome
Assest the dose of 15µg of follitropin delta aimed at obtaining 17 oocytes (considering the optimal range of oocytes from 15 to 25).
Time frame: Number of oocytes obtained inmediatly after the ovarian puncture in visit 5
To evaluate the number of oocytes of a fixed dose of 15µg of the drug Rekovelle (follitropin delta) during the entire stimulation of oocyte donors aimed at obtaining 17 oocytes (considering the optimal range of oocytes from 15 to 25).
Measure the incidence of ovarian hyperstimulation syndrome using15µg of follitropin delta aimed at obtaining 17 oocytes
Time frame: Through the study completion, an average 1 month.
Evaluate with a GOLAN scale. Golan classification: Classify early or late ovarian hyperstimulation syndrome, according to clinic, ultrasound and laboratory tests Mild ovarian hyperstimulation: * Grade 1 Abdominal discomfort and bloating * Grade 2 Grade 1 + nausea, vomiting, or diarrhea. Ovaries enlarged 5-12 cm in ø Moderate Hyperstimulation: • Grade 3 Grade 2 + ultrasound signs of ascites Severe hyperstimulation: * Grade 4 Grade 3 + clinical ascites, respiratory distress, hydrothorax * Grade 5 Grade 4 and hemoconcentration, hypovolemia, impaired coagulation and renal function (oligo / anuria)
5 secondary outcomes
Number of mature oocytes
Time frame: Number of madure oocytes obtained inmediatly after the puncture in visit 5
Duration of stimulation in days
Time frame: Number of days during the ovarian stimulation up to 20 days
Number of blasts
Time frame: 4-6 days after fertilization and before implantation in the endometrium during the treatment.
Blast quality
Time frame: 4-6 days after fertilization and before implantation in the endometrium during the treatment.
Degree of satisfaction with the infertility treatment
Time frame: At the end of the treatment, an average 1 month.
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 14 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for IVF
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
RecruitingPhase 2
Ubiquinone vs. Ubiquinol Supplementation
IVF
Active, not recruitingPhase 1/2
Opt-IVF for Personalized Medicine for Normal Responders
Ivf
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 Phase 2 study testing Follitropin Delta, Recombinant in people with IVF, run by IVI Madrid at 1 site in Spain.
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 10 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 14 Nov 2022. 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 Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Assest the dose of 15µg of follitropin delta aimed at obtaining 17 oocytes (considering the optimal range of oocytes from 15 to 25). (time frame: Number of oocytes obtained inmediatly after the ovarian puncture in visit 5). The study lists 2 primary outcomes in all. 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 14 Nov 2022.