NCT02792569

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration 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

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 7, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

2.7 years

First QC Date

May 23, 2016

Last Update Submit

January 29, 2020

Conditions

Infertility

Keywords

IVAHippo PathwayFollicle activationLow ResponderPOIPoor Ovarian ReservePoor Ovarian ResponseSalvador/Warts/Hippo pathway

Outcome Measures

Primary Outcomes (1)

  • Number of follicles > 12 mm

    Number of follicles \> 12 mm in response to controlled ovarian stimulation with corifollitropin from the biopsied ovary versus the contralateral untreated ovary

    Up to 6 month after the auto-transplantation

Secondary Outcomes (1)

  • Side of ovulation

    Up to 6 months after auto-transplantation

Other Outcomes (3)

  • AFC count

    Up to 10 month after auto-transplantation

  • AMH changes

    Up up to 10 month after auto-transplantation

  • Pregnancy

    Through study completion, an average of 1 year

Study Arms (2)

Biopsy at Right side

EXPERIMENTAL

Biopsy of ovarian cortical tissue (50% right side)

Procedure: Biopsy of ovarian cortical tissue

Biopsy at Left side

EXPERIMENTAL

Biopsy of ovarian cortical tissue (50% left side)

Procedure: Biopsy of ovarian cortical tissue

Interventions

Biopsy of ovarian cortical tissuePROCEDURE

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.

Biopsy at Left sideBiopsy at Right side

Eligibility Criteria

Age25 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Related Publications (4)

  • Kawamura K, Cheng Y, Suzuki N, Deguchi M, Sato Y, Takae S, Ho CH, Kawamura N, Tamura M, Hashimoto S, Sugishita Y, Morimoto Y, Hosoi Y, Yoshioka N, Ishizuka B, Hsueh AJ. Hippo signaling disruption and Akt stimulation of ovarian follicles for infertility treatment. Proc Natl Acad Sci U S A. 2013 Oct 22;110(43):17474-9. doi: 10.1073/pnas.1312830110. Epub 2013 Sep 30.

    PMID: 24082083BACKGROUND

  • Hsueh AJ, Kawamura K, Cheng Y, Fauser BC. Intraovarian control of early folliculogenesis. Endocr Rev. 2015 Feb;36(1):1-24. doi: 10.1210/er.2014-1020. Epub 2014 Sep 9.

    PMID: 25202833BACKGROUND

  • Suzuki N, Yoshioka N, Takae S, Sugishita Y, Tamura M, Hashimoto S, Morimoto Y, Kawamura K. Successful fertility preservation following ovarian tissue vitrification in patients with primary ovarian insufficiency. Hum Reprod. 2015 Mar;30(3):608-15. doi: 10.1093/humrep/deu353. Epub 2015 Jan 6.

    PMID: 25567618BACKGROUND

  • Lunding SA, Pors SE, Kristensen SG, Landersoe SK, Jeppesen JV, Flachs EM, Pinborg A, Macklon KT, Pedersen AT, Andersen CY, Andersen AN. Biopsying, fragmentation and autotransplantation of fresh ovarian cortical tissue in infertile women with diminished ovarian reserve. Hum Reprod. 2019 Oct 2;34(10):1924-1936. doi: 10.1093/humrep/dez152.

    PMID: 31593582DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Anders N Andersen, Professor

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor M.D.

Study Record Dates

First Submitted

May 23, 2016

First Posted

June 7, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

January 30, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)