NCT02354963

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

January 8, 2024

Completed
Last Updated

January 8, 2024

Status Verified

March 1, 2023

Enrollment Period

4.3 years

First QC Date

January 22, 2015

Results QC Date

April 12, 2022

Last Update Submit

March 29, 2023

Conditions

Infertility

Keywords

Poor ovarian responseSalvador/Warts/Hippo pathwayFollicular activationPoor ovarian reserve

Outcome Measures

Primary Outcomes (1)

  • Number of Metaphase II (MII)

    Number of mature MII oocytes retrieved in the IVF cycles after triggering.

    36 hours after triggering

Secondary Outcomes (9)

  • Total Antral Follicle Count (AFC) - Initial Measure

    Baseline, day 2-5 of the menstrual cycle prior to treatment

  • Total Antral Follicle Count (AFC) - Final

    Day 2-5 of the menstrual cycle 6 months after treatment

  • Initial Antimüllerian Hormone (AMH) Levels

    Baseline, day 2-5 of the menstrual cycle prior to treatment

  • Final AMH Levels

    Day 2-5 of the menstrual cycle 6 months after the treatment

  • Number of Cancelled IVF Cycles

    End of stimulation cycle (less than or equal to 30 days)

  • +4 more secondary outcomes

Study Arms (2)

Control arm

NO INTERVENTION

No intervention is performed. Assessment of antral follicle count. IVF treatment.

Experimental arm

EXPERIMENTAL

Perform intervention described: Laparoscopy. In vitro fragmentation of the ovarian tissue. Assessment of antral follicle count. IVF treatment.

Procedure: In vitro fragmentation of the ovarian tissue

Interventions

In vitro fragmentation of the ovarian tissuePROCEDURE

Unilateral ovarian cortex extraction, in vitro fragmentation and reimplantation.

Experimental arm

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Fe University Hospital

Valencia, Spain

Location

Related Publications (1)

  • Diaz-Garcia C, Herraiz S, Pamplona L, Subira J, Soriano MJ, Simon C, Seli E, Pellicer A. Follicular activation in women previously diagnosed with poor ovarian response: a randomized, controlled trial. Fertil Steril. 2022 Apr;117(4):747-755. doi: 10.1016/j.fertnstert.2021.12.034.

    PMID: 35367015DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Results Point of Contact

Title
Dr Cesar Diaz-Garcia
Organization
IIS La Fe
cesar.diaz@ivirma.com
961 24 67 00

Study Officials

  • Cesar Diaz-Garcia, MD

    La Fe University Hospital. University of Valencia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD, MD

Study Record Dates

First Submitted

January 22, 2015

First Posted

February 3, 2015

Study Start

November 1, 2014

Primary Completion

February 1, 2019

Study Completion

December 1, 2019

Last Updated

January 8, 2024

Results First Posted

January 8, 2024

Record last verified: 2023-03

Locations

ES(1)