Ovarian Fragmentation Study (Crespo Medical Team)

March 10, 2020 updated by: Equipo Juana Crespo
This is a study designed to validate Kawamura´s theory and investigation of activation of primordial follicles through ovarian cortex fragmentation. Our aim is to evaluate embryo quality following this procedure in poor ovarian responders and patients with decreased ovarian reserve. Secondary objectives are to assess potential association with the number of oocytes retrieved and pregnancy rates after IVF.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46000
        • Ander Morales Vicente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Abdominal surgery need for fertility cause.
  • Bad embryo quality (>2 cycles with < 1 embryo A-B quality. With:

A. Poor ovarian responders (previous ≤ 3 retrieved metaphase II oocytes) in a conventional cycle.

B. Decreased ovarian reserve (antral follicle count (AFC) ≤ 5 or antiMullerian hormone (AMH) ≤ 0.5 ng/mL).

C.Premature ovarian insufficiency according to:

  • Patients < 40 years old.
  • At least 1 year of amenorrhea.
  • Follitropin serum levels (FSH) >35 IU/ml in two serum samples separated by at least 1 month.
  • Estradiol serum levels (E2) < 20 pg/mL.

Exclusion Criteria:

  1. Clinical/ultrasonographical signs of severe endometriosis ( or endometrioma).
  2. Age over 45 years (EMC)
  3. Previous ovarian/pelvic surgery. Unilateral oophorectomy.
  4. Body Mass Index > 30
  5. Previous gonadotoxic treatment.
  6. Genito-urinary tract malformations.
  7. Inform consent unsigned.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OVARIAN FRAGMENTATION
Ovarian fragmentation through laparoscopy in patients who meet criteria ( Poor ovarian responders and poor ovarian reserve).
Procedure: OVARIAN FRAGMENTATION
BILATERAL OVARIAN CORTEX FRAGMENTATION USING LAPAROSCOPIC SCISSORS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Embryo quality improvement following ovarian fragmentation (Using ASEBIR Embryo Classification, 2015)
Time Frame: 1 year
Embryo quality improvement following ovarian cortex fragmentation in poor ovarian responders or patients with premature ovarian insufficency using ASEBIR Classification (2015).
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- Follicle growth rate before and after ovarian cortex fragmentation.
Time Frame: 2 months.
Number of antral Follicles in IVF treatment before ovarian fragmentation and after IVF following ovarian fragmentation.
2 months.
- Oocyte number and M-II oocyte (mature oocytes) before and after ovarian cortex fragmentation.
Time Frame: 2 months
2 months
- AntiMullerian hormone (AMH) serum levels before and two months after the procedure.
Time Frame: 2 months.
2 months.
- Number of embryos before and after ovarian cortex fragmentation.
Time Frame: 2 months
2 months
- Clinical pregnancy rate following ovarian cortex fragmentation.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Equipo Juana Crespo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2020

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

March 6, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (Actual)

March 12, 2020

Study Record Updates

Last Update Posted (Actual)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fibrotomia1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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