Fertility DisordersPhase 4DUOPICKNCT03846544
Double Pick up in Poor Prognosis Women
A Phase 4 study testing Corifollitoropin alfa (CFA)-double pick up in people with Fertility Disorders, run by CRG UZ Brussel at 1 site in Belgium.
Trial summary
The purpose of this randomized pilot study is to compare the efficacy of double oocyte retrieval vs. conventional antagonist ovarian stimulation protocol in poor prognosis patients undergoing in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI). Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Fertility Disorders
- What is being tested?
- Corifollitoropin alfa (CFA)-double pick up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2019to 1 Oct 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 25-40 years
- Body mass index (BMI) ≤ 35 and ≥ 19
- Antimüllerian hormone (AMH) level of ≤1.5 ng/mL or antral follicular count (AFC) of ≤6 follicles or ≤5 oocytes retrieved in a previous cycle following standard conventional ovarian stimulation.
Who cannot join
- Testicular sperm extraction
- History of > 3 three consecutive previous unsuccessful IVF cycles
- BMI >35 or <19
- Use of oral contraceptives <3 months before start of the treatment
- polycystic ovary syndrome (PCOS) according to the Rotterdam criteria
- Ovarian stimulation for pre-implantation genetic testing (PGT-A/M)
Show all 10Show fewer
- Medical/social freezing
- In vitro maturation (IVM)
- History of untreated autoimmune, endocrine or metabolic disorders,
- Ovarian cystectomy or oophorectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Trigger and Ovum Retrieval vs. Conventional Antagonist Ovarian Stimulation Protocol in Poor Prognosis Women Undergoing IVF/ICSI: A Pilot Randomized Study
The purpose of this randomized pilot study is to compare the efficacy of double oocyte retrieval vs. conventional antagonist ovarian stimulation protocol in poor prognosis patients undergoing in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI).
- Conditions
- Fertility Disorders
- Being tested
- Corifollitoropin alfa (CFA)-double pick up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corifollitoropin alfa (CFA)-double pick upDrug
In the study group, 225 IU of recombinant FSH (rFSH) will continue after the first oocyte retrieval (OR). Antagonist administration will be initiated when at least one follicle measuring ≥14 mm will be present in the ultrasound. If one or more follicles ≥17 mm are observed, patients will undergo a second triggering with human chorionic gonadotropin (hCG) 5000 IU and a second OR will be performed. In case of patients with no follicular development following 10 additional days of rFSH post-OR
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| double pick up group | Experimental | Not described Receives: Drug: Corifollitoropin alfa (CFA)-double pick up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of MII Oocytes Retrieved Between the Two Arms
number of mature (or metaphase II, MII) oocytes retrieved during oocyte retrieval
Measured: 1 month
Secondary outcomes (8)
Number of Preovulatory Follicles
number of follicles ≥11m on the day of final oocyte maturation trigger
Measured: 1 month
Number of Cumulus Oocyte Complexes (COCs) Retrieved
number of COCs retrieved at oocyte retrieval
Measured: 1 month
Number of Oocytes Fertilized
number of fertilized oocytes at day 1 after oocyte retrieval
Measured: 1 month
Total Number of Available Embryos
number of available embryos at day 3 or day 5 after oocyte retrieval, good quality and therefore transferable
Measured: 1 month
Duration of Ovarian Stimulation
number of days of ovarian stimulation
Measured: 1 month
Clinical Pregnancy Rates
clinical pregnancy rate
Measured: 4 months
Live Birth Rates
number of live births
Measured: 12 months
Cumulative Live Birth Rates
defined as the first live birth following the transfer of fresh and subsequent frozen-thawed embryos
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start1 Oct 2019
- Primary completion15 Sep 2021
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fertility DisordersStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- CRG UZ Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panagiotis Drakopoulos, CRG UZ Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846544
- Sponsor's protocol ID
- 58335
- Acronym
- DUOPICK
- Status last verified
- Apr 2024
- First submitted
- 15 Feb 2019
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boudry L, Mateizel I, Wouters K, Papaleo E, Mackens S, De Vos M, Racca A, Adriaenssens T, Tournaye H, Blockeel C. Does dual oocyte retrieval with continuous FSH administration increase the number of mature oocytes in low responders? An open-label randomized controlled trial. Hum Reprod. 2024 Mar 1;39(3):538-547. doi: 10.1093/humrep/dead276.
PubMed 38199789
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Trigger and Ovum Retrieval vs. Conventional Antagonist Ovarian Stimulation Protocol in Poor Prognosis Women Undergoing IVF/ICSI: A Pilot Randomized Study
- ClinicalTrials.gov ID
- NCT03846544
- Acronym / sponsor ID
- DUOPICK / 58335
- Conditions
- Fertility Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- CRG UZ BrusselUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Posted 15 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized pilot study is to compare the efficacy of double oocyte retrieval vs. conventional antagonist ovarian stimulation protocol in poor prognosis patients undergoing in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| double pick up group | Experimental | Drug: Corifollitoropin alfa (CFA)-double pick up |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 25-40 years
- Body mass index (BMI) ≤ 35 and ≥ 19
- Antimüllerian hormone (AMH) level of ≤1.5 ng/mL or antral follicular count (AFC) of ≤6 follicles or ≤5 oocytes retrieved in a previous cycle following standard conventional ovarian stimulation.
Key exclusion criteria (10 listed)
- Testicular sperm extraction
- History of > 3 three consecutive previous unsuccessful IVF cycles
- BMI >35 or <19
- Use of oral contraceptives <3 months before start of the treatment
- polycystic ovary syndrome (PCOS) according to the Rotterdam criteria
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 |
|---|---|---|
| Corifollitoropin alfa (CFA)-double pick upIn the study group, 225 IU of recombinant FSH (rFSH) will continue after the first oocyte retrieval (OR). Antagonist administration will be initiated when at least one follicle measuring ≥14 mm will be present in the ultrasound. If one or more follicles ≥17 mm are observed, patients will undergo a second triggering with human chorionic gonadotropin (hCG) 5000 IU and a second OR will be performed. In case of patients with no follicular development following 10 additional days of rFSH post-OR | Drug | double pick up group |
Primary outcome
Number of MII Oocytes Retrieved Between the Two Arms
Time frame: 1 month
number of mature (or metaphase II, MII) oocytes retrieved during oocyte retrieval
8 secondary outcomes
Number of Preovulatory Follicles
Time frame: 1 month
Number of Cumulus Oocyte Complexes (COCs) Retrieved
Time frame: 1 month
Number of Oocytes Fertilized
Time frame: 1 month
Total Number of Available Embryos
Time frame: 1 month
Duration of Ovarian Stimulation
Time frame: 1 month
Clinical Pregnancy Rates
Time frame: 4 months
Live Birth Rates
Time frame: 12 months
Cumulative Live Birth Rates
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38199789Boudry L, Mateizel I, Wouters K, Papaleo E, Mackens S, De Vos M, Racca A, Adriaenssens T, Tournaye H, Blockeel C. Does dual oocyte retrieval with continuous FSH administration increase the number of mature oocytes in low responders? An open-label randomized controlled trial. Hum Reprod. 2024 Mar 1;39(3):538-547. doi: 10.1093/humrep/dead276.
- Individual participant dataSharing planned: No
Related trials for Fertility Disorders
Active, not recruiting
Ovarian Tissue Cryopreservation in Children
Cancer
Not yet recruiting
Sperm, Exposure and Endocrine Disruptors
Fertility, Male Fertility
Recruiting
Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF
Endometriosis
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
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 4 study testing Corifollitoropin alfa (CFA)-double pick up in people with Fertility Disorders, run by CRG UZ 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 3 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 21 May 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 MII Oocytes Retrieved Between the Two Arms (time frame: 1 month). 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 NCT03846544, which also lists 1 linked publication.
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 21 May 2024.