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BRCA mutations and Ovarian ageing in women applying for in vitro fertilization and preimplantation genetiC diAgnosis

BRCA mutations and Ovarian ageing in women applying for in vitro fertilization and preimplantation genetiC diAgnosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21616
Enrollment
125
Registered
2014-07-25
Start date
2014-08-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BRCA1/2, ovarian reserve (AFC, AMH, ovarian response), ongoing pregnancy BRCA1/2, ovariele reserve (AFC, AMH, ovariele response), doorgaande zwangerschap

Interventions

blood sample

Sponsors

Participating sites: UMC Utrecht, Maastricht UMC+, Academic Hospital Brussels, UMC Groningen, Academic Medical Center Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Case group (BRCA mutation carriers) - Female age > 18 years and 18 years and < 40 years - Regular menstrual cycles (i.e. mean cycle length of 21-35 days) - First IVF with ICSI and PGD treatment cycle due to an indication unsuspected for reduced ovarian reserve status - Written informed consent

Exclusion criteria

Exclusion criteria: Case group (BRCA mutation carriers) - Ovarian surgery - Chemo therapy - Radiation therapy to the pelvis, lower abdomen or total body radiation - Known female endocrine or autoimmune abnormalities (i.e. Cushing syndrome, type I Diabetes Mellitus, hypothyroidism, hyperprolactinemia, adrenal insufficiency, hypoparathyriodism, myasthenia gravis, rheumatoid arthritis, systemic lupus erythematosus) - Body Mass Index > 35 kg/m2 - Polycystic Ovarian Syndrome (Rotterdam criteria) - Early follicular FSH > 15 IU/L - Known Human immunodeficiency virus (HIV) infection - Known female genetic abnormalities suspected for subfertility (structural or numerical abnormalities of the X-chromosome (i.e. Turner¡¯s syndrome, fragile X syndrome), or abnormalities of human autosomal functionally relevant genes, other than a BRCA mutation, suspected for subfertility Controle group (non suspected for BRCA mutation): - Ovarian surgery - Chemo therapy - Radiation therapy to the pelvis, lower abdomen or total body radiation - Known female endocrine or autoimmune abnormalities (i.e. Cushing syndrome, type I Diabetes Mellitus, hypothyroidism, hyperprolactinemia, adrenal insufficiency, hypoparathyriodism, myasthenia gravis, rheumatoid arthritis, systemic lupus erythematosus) - Body Mass Index > 35 kg/m2 - Polycystic Ovarian Syndrome (Rotterdam criteria) - Early follicular FSH > 15 IU/L - Known HIV infection - Known genetic abnormalities, suspected for subfertility (structural or numerical abnormalities of the X-chromosome (i.e. Turner¡¯s syndrome, fragile X syndrome), or abnormalities of human autosomal functionally relevant genes suspected for subfertility

Design outcomes

Primary

MeasureTime frame
Serum AMH level

Secondary

MeasureTime frame
- AFC - Amount of poor response (less than 4 oocytes at retrieval or cancellation due to insufficient follicle growths, i.e. < 4 dominant follicles sized ¡Ý14 mm growing) - Number of retrieved oocytes (total amount and MII) after first cycle COH - Ongoing and clinical pregnancy rate

Contacts

Public ContactF.J. Broekmans

Heidelberglaan 100

f.broekmans@umcutrecht.nl+31 (0)88 7551041

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)