Phase 4
Completed N=48
Double Pick up in Poor Prognosis Women
Fertility Disorders
Source: ClinicalTrials.gov NCT03846544 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Number of MII Oocytes Retrieved Between the Two Arms — 4.1; 3.0 number of oocytes
◆ Published Evidence
Emerging
12citations · ~6 / year
Does dual oocyte retrieval with continuous FSH administration increase the number of mature oocytes in low responders? An open-label randomized controlled 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).
Linked Publications
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Does dual oocyte retrieval with continuous FSH administration increase the number of mature oocytes in low responders? An open-label randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of MII Oocytes Retrieved Between the Two Arms |
4.1; 3.0 | — |
| SECONDARY Number of Preovulatory Follicles |
5.4; 5.0 | — |
| SECONDARY Number of Cumulus Oocyte Complexes (COCs) Retrieved |
5.3; 3.3 | — |
| SECONDARY Number of Oocytes Fertilized |
3.7; 2.3 | — |
| SECONDARY Total Number of Available Embryos |
1.5; 1.4 | — |
| SECONDARY Duration of Ovarian Stimulation |
9.9; 9.9 | — |
| SECONDARY Clinical Pregnancy Rates |
7; 13 | — |
| SECONDARY Live Birth Rates |
6; 8 | — |
| SECONDARY Cumulative Live Birth Rates |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03846544) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.