Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2016-04-30
2019-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Biopsy at Right side
Biopsy of ovarian cortical tissue (50% right side)
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.
Biopsy at Left side
Biopsy of ovarian cortical tissue (50% left side)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Known chromosomal abnormality
* Known autoimmune disease (except TPO-antibodies)
* Patients who have contraindication for laparoscopy
25 Years
39 Years
FEMALE
No
Sponsors
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Anders Nyboe Andersen
OTHER
Responsible Party
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Anders Nyboe Andersen
Professor M.D.
Principal Investigators
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Anders N Andersen, Professor
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital
Copenhagen, , Denmark
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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H-15011975
Identifier Type: -
Identifier Source: org_study_id
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