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Follicle Activation by Inhibition of the Hippo Pathway

A

Anders Nyboe Andersen

Status

Completed

Conditions

Infertility

Treatments

Procedure: Biopsy of ovarian cortical tissue

Study type

Interventional

Funder types

Other

Identifiers

NCT02792569
H-15011975

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

Female

Ages

25 to 39 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Biopsy at Right side
Experimental group
Description:
Biopsy of ovarian cortical tissue (50% right side)
Treatment:
Procedure: Biopsy of ovarian cortical tissue
Biopsy at Left side
Experimental group
Description:
Biopsy of ovarian cortical tissue (50% left side)
Treatment:
Procedure: Biopsy of ovarian cortical tissue

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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