N/A
N=34
Follicular Activation in Poor Responders
Infertility
Bottom Line
View on ClinicalTrials.gov: NCT02354963 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Number of Metaphase II (MII) — 4; 2 Oocytes — p=0.302
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- In vitro fragmentation of the ovarian tissue (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- César Díaz García
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Metaphase II (MII) |
4; 2 | 0.302 |
| SECONDARY Total Antral Follicle Count (AFC) - Initial Measure |
5; 4 | 0.449 |
| SECONDARY Total Antral Follicle Count (AFC) - Final |
5; 5 | 0.021 sig |
| SECONDARY Initial Antimüllerian Hormone (AMH) Levels |
0.36; 0.44 | 0.427 |
| SECONDARY Final AMH Levels |
0.35; 0.29 | 0.496 |
| SECONDARY Number of Cancelled IVF Cycles |
3; 2 | 0.684 |
| SECONDARY Fertilization Rate |
100; 33.3 | 0.480 |
| SECONDARY Number of Cycles With Embryo Transfer (ET) |
8; 4 | 0.236 |
| SECONDARY Number and Percentage of Cycles With Clinical Pregnancy |
3; 2 | 0.684 |
| SECONDARY Live Birth Rate |
3; 1 | 0.512 |
Summary
This study aims to assess whether activation of primordial follicles through ovarian cortex fragmentation may increase the number of antral follicles present in the ovary of patients with diminished ovarian reserve. Secondary outcomes include number of oocytes retrieved and pregnancy rates after IVF.
Hypothesis; Evaluate whether the proposed intervention increases the pool of antral follicles (potentially stimulable ones).
Eligibility Criteria
Inclusion Criteria (must meet one):
- At least two episodes of poor ovarian response (≤ 3 oocytes retrieved with a standard protocol).
- A previous IVF cycle with ≤ 3 oocytes (following a standard stimulation protocol) and presence of an abnormal ovarian reserve test (antral follicle count of ≤ 5 or antimüllerian hormone ≤ 5pm).
Exclusion Criteria (must not meet any):
- Patients under 18 or over 40 years.
- Clinical signs of endometriosis.
- Previous ovarian surgery.
- Genital tract malformations.
- Anovulatory patient (defined by the presence of irregular cycles and serum progesterone ≤ 10 ng / mL on cycle day 21).
- Partner with severe male factor: severe oligoasthenozoospermia, oligoasthenoteratozoospermia and azoospermia.
- All those patients who do not voluntarily give their express written consent.
Data sourced from ClinicalTrials.gov (NCT02354963). 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.