Infertility Clinical Trial
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
NCT number | NCT02792569 |
Other study ID # | H-15011975 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | January 2019 |
Verified date | January 2020 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 2019 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 39 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Anders Nyboe Andersen |
Denmark,
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. Review. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | AFC count | Number of antral follicles (AFC) at the biopsy side versus that of the contralateral side | Up to 10 month after auto-transplantation | |
Other | AMH changes | 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 | Up up to 10 month after auto-transplantation | |
Other | Pregnancy | Numbers of pregnancies (spontaneously/assisted) | Through study completion, an average of 1 year | |
Primary | 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 | Side of ovulation | Frequency of ovulations occurring at the "biopsy side" versus the contralateral side in the subsequent 4- 6 months | Up to 6 months after auto-transplantation |
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