Primary outcomeMean· 1 month
Number of MII Oocytes Retrieved Between the Two Arms
| Group | Value (number of oocytes) | Spread |
|---|---|---|
| Control Group | 4.1 | 2.4 |
| Double Pick up Group | 3.0 | 2.2 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataDouble Pick up in Poor Prognosis Women
Short name DUOPICK
NCTNCT03846544 (opens ClinicalTrials.gov in a new tab)Other id58335
This trial does not test a peptide that PepBank tracks.
- Names hCG (human chorionic gonadotropin), does not test it. It appears in the description.
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 48 participants (actual)
- Sponsor
- CRG UZ Brussel · Other
- Design
- Randomized · Double masking
- Countries
1 country
Belgium
- Start
- 1 Oct 2019
- Primary completion
- 15 Sept 2021
- Completion
- 1 Oct 2022
- First posted
- 19 Feb 2019
- Last update posted
- 21 May 2024
- Conditions
- Fertility Disorders
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20192020202120222023
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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).
Interventions
- Corifollitoropin alfa (CFA)-double pick upDrug
Arms2
No intervention
control group
Experimental
double pick up group
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of MII Oocytes Retrieved Between the Two Arms
Time frame · 1 month
Registry description
number of mature (or metaphase II, MII) oocytes retrieved during oocyte retrieval
Secondary outcomes(8)
Number of Preovulatory Follicles
Time frame · 1 month
Registry description
number of follicles ≥11m on the day of final oocyte maturation trigger
Number of Cumulus Oocyte Complexes (COCs) Retrieved
Time frame · 1 month
Registry description
number of COCs retrieved at oocyte retrieval
Number of Oocytes Fertilized
Time frame · 1 month
Registry description
number of fertilized oocytes at day 1 after oocyte retrieval
Total Number of Available Embryos
Time frame · 1 month
Registry description
number of available embryos at day 3 or day 5 after oocyte retrieval, good quality and therefore transferable
Duration of Ovarian Stimulation
Time frame · 1 month
Registry description
number of days of ovarian stimulation
Clinical Pregnancy Rates
Time frame · 4 months
Registry description
clinical pregnancy rate
Live Birth Rates
Time frame · 12 months
Registry description
number of live births
Cumulative Live Birth Rates
Time frame · 24 months
Registry description
defined as the first live birth following the transfer of fresh and subsequent frozen-thawed embryos
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· 1 month
Number of Preovulatory Follicles
| Group | Value (number of follicles) | Spread |
|---|---|---|
| Control Group | 5.4 | 2.2 |
| Double Pick up Group | 5.0 | 1.6 |
Secondary outcomeMean· 1 month
Number of Cumulus Oocyte Complexes (COCs) Retrieved
| Group | Value (number of oocytes) | Spread |
|---|---|---|
| Control Group | 5.3 | 2.7 |
| Double Pick up Group | 3.3 | 2.2 |
Secondary outcomeMean· 1 month
Number of Oocytes Fertilized
| Group | Value (number of fertilized oocytes) | Spread |
|---|---|---|
| Control Group | 3.7 | 2.4 |
| Double Pick up Group | 2.3 | 2.0 |
Secondary outcomeMean· 1 month
Total Number of Available Embryos
| Group | Value (number of embryos) | Spread |
|---|---|---|
| Control Group | 1.5 | 0.9 |
| Double Pick up Group | 1.4 | 1.3 |
Secondary outcomeMean· 1 month
Duration of Ovarian Stimulation
| Group | Value (days) | Spread |
|---|---|---|
| Control Group | 9.9 | 2.7 |
| Double Pick up Group | 9.9 | 3.0 |
Secondary outcomeCount of participants· 4 months
Clinical Pregnancy Rates
| Group | Value (Participants) |
|---|---|
| Control Group | 7 |
| Double Pick up Group | 13 |
Secondary outcomeCount of participants· 12 months
Live Birth Rates
| Group | Value (Participants) |
|---|---|
| Control Group | 6 |
| Double Pick up Group | 8 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Control Groupconventional stimulation group | 0 / 24 | 0 / 24 | 0 / 24 |
| Double Pick up GroupCFA-double pick up: In the study group, 225 IU of 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 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 | 0 / 24 | 0 / 24 | 0 / 24 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedBoudry 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. PMID 38199789
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 25 Years up to 40 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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)
* Medical/social freezing
* In vitro maturation (IVM)
* History of untreated autoimmune, endocrine or metabolic disorders,
* Ovarian cystectomy or oophorectomy
PepBank is a research reference. Talk to a doctor before you use any peptide.