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 - BROCA-2 sudy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47054

Enrollment

109

Registered

2014-07-10

Start date

2014-10-29

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

ovarian ageing ovarian reserve

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Case group: Female age * 40 years Regular menstrual cycles (i.e. mean cycle length of 21-35 days) First IVF with ICSI and PGD treatment cycle due to a female pathogenic BRCA mutation Written informed consent;Control group: Female age * 18 years and * 40 years Regular menstrual cycles (i.e. mean cycle length of 21-35 days, with the next menstrual period predictable within a 7 days* time frame) 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: Ovarian surgery Chemotherapy 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 > 30 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, other than a BRCA mutation. ;Control group: Ovarian surgery Chemotherapy 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 > 30 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 on human autosomal functionally relevant genes suspected for subfertility. PGD requested for structural chromosomal abnormalities

Design outcomes

Primary

Measure	Time frame
Ovarian ageing measured by serum AMH levels.	—

Secondary

Measure	Time frame
Antral follicle count Ovarian response (oocytes yielded, MII ooocytes, poor response) Clinical pregnancy rate Ongoing pregnancy rate	—

Countries

Netherlands

Outcome results