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Trial record 49 of 416 for:    Recruiting, Not yet recruiting, Available Studies | "Infertility"

Follicle Activation by Inhibition of the Hippo Pathway

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ClinicalTrials.gov Identifier: NCT02792569
Recruitment Status : Recruiting
First Posted : June 7, 2016
Last Update Posted : June 8, 2016
Sponsor:
Information provided by (Responsible Party):
Anders Nyboe Andersen, Rigshospitalet, Denmark

Brief Summary:
The aim of this project is to activate recruitment and growth of resting primordial follicles in the ovaries of women with diminished ovarian reserve, in attempt to increase the chance to become pregnant, either naturally or after assisted reproduction.

Condition or disease Intervention/treatment Phase
Infertility Procedure: Biopsy of ovarian cortical tissue Not Applicable

Detailed Description:

For this study investigators will carefully select 20 women with low AMH and imminent POI.

They will be randomized to have cortical ovarian biopsies taken from either the left or right ovary. The biopsies will be fragmented in 1x1 mm2 pieces and immediately auto-transplanted in a peritoneal pocket under the right ovary.

The contralateral untouched ovary will act as the control, making each woman their own control.

Follow up: each week in 2,5 months the women will be assessed by transvaginal ultrasound and hormonal status. After 2,5-6 months the women will receive a FSH stimulation cycle (rFSH 300 IU or Corifollitropin) followed by standard IVF/ICSI,

Hypothesis: the ovaries contain a pool of resting primordial follicles. By fragmentation of cortical ovarian tissue, manipulation of the local environment in the tissue will inhibit the Hippo Pathway and hereby active recruitment and growth of primordial follicles.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Auto-transplantation of Fragmented Ovarian Cortical Tissue in Infertile Patients With Premature Ovarian Oocyte Depletion - a Study to Promote Follicular Activation and Subsequent Fertility
Study Start Date : April 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Infertility

Arm Intervention/treatment
Experimental: Biopsy at Right side
Biopsy of ovarian cortical tissue (50% right side)
Procedure: Biopsy of ovarian cortical tissue
Biopsies will be taken from either right or left side. The cortical tissue will be isolated and fragmented in 1x1 mm2 pieces, followed by auto-transplantation to a peritoneal pocket.

Experimental: Biopsy at Left side
Biopsy of ovarian cortical tissue (50% left side)
Procedure: Biopsy of ovarian cortical tissue
Biopsies will be taken from either right or left side. The cortical tissue will be isolated and fragmented in 1x1 mm2 pieces, followed by auto-transplantation to a peritoneal pocket.




Primary Outcome Measures :
  1. Number of follicles > 12 mm [ Time Frame: Up to 6 month after the auto-transplantation ]
    Number of follicles > 12 mm in response to controlled ovarian stimulation with corifollitropin from the biopsied ovary versus the contralateral untreated ovary


Secondary Outcome Measures :
  1. Side of ovulation [ Time Frame: Up to 6 months after auto-transplantation ]
    Frequency of ovulations occurring at the "biopsy side" versus the contralateral side in the subsequent 4- 6 months


Other Outcome Measures:
  1. AFC count [ Time Frame: Up to 10 month after auto-transplantation ]
    Number of antral follicles (AFC) at the biopsy side versus that of the contralateral side

  2. AMH changes [ Time Frame: Up up to 10 month after auto-transplantation ]
    Changes (increase - decrease) in serum AMH over time, using the highly sensitive new AMH Assay (Elecsys Assay; Roche), which has been implemented as a routine analysis at The Department of Clinical Biochemistry Rigshospitalet in June 1st 2015

  3. Pregnancy [ Time Frame: Through study completion, an average of 1 year ]
    Numbers of pregnancies (spontaneously/assisted)



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Ages Eligible for Study:   25 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infertility with indication for IVF/ICSI
  • Imminent POI, still cycling
  • Age 25 - 39 years
  • Two ovaries
  • Serum AMH measurements < 5 pmol/l (two independent measurements)
  • Antral follicle count (AFC) (sum of both ovaries < 5)

Exclusion Criteria:

  • Ovarian pathology (endometriosis, cysts)
  • Known chromosomal abnormality
  • Known autoimmune disease (except TPO-antibodies)
  • Patients who have contraindication for laparoscopy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792569


Contacts
Contact: Stine Aa Lunding, MD + 45 3545 0861 stine.aagaard.lunding@regionh.dk
Contact: Anders N Andersen, Professor + 45 3545 1315 anders.nyboe.andersen@regionh.dk

Locations
Denmark
The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital Recruiting
Copenhagen, Denmark, 2100
Contact: Anne N Egeberg, Study Nurse    +45 3545 0986    anne.noes.egeberg@regionh.dk   
Contact: Line Hedegaard, Study Nurse    +45 3545 0986    line.hedegaard@regionh.dk   
Principal Investigator: Stine Aa Lunding, MD         
Sponsors and Collaborators
Anders Nyboe Andersen
Investigators
Principal Investigator: Anders N Andersen, Professor Rigshospitalet, Denmark

Publications:
Responsible Party: Anders Nyboe Andersen, Professor M.D., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02792569     History of Changes
Other Study ID Numbers: H-15011975
First Posted: June 7, 2016    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Anders Nyboe Andersen, Rigshospitalet, Denmark:
IVA
Hippo Pathway
Follicle activation
Low Responder
POI
Poor Ovarian Reserve
Poor Ovarian Response
Salvador/Warts/Hippo pathway

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female