Impact of guidance and consultation management program on women undergoing non-ART infertility treatment

UMIN ID: UMIN000027424

Registered date:01/07/2017

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Women with infertility to receive non-ART infertility treatment
• Date of first enrollment: 2017/07/01
• Target sample size: 310
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intervention period is six months Three times interventions at the first time, after three months, and after six months We perform the guidance and consultation management program by physician and nurse for 30 minites. No treatment, usual practice to Intervention 1
Usual practice

Outcome(s)

• Primary Outcome: Health Related Quality of Life Time of the measurement is at start of treatment, three months later, six months later and 12 months later
• Secondary Outcome: 1.Fertility quality of life. 2.The required time until pregnancy: The days from start of treatment to pregnancy test positive; The number of the treatment cycle. 3.The cost of treatment 4.Drop-out rate from treatment: The patients not visiting a hospital for treatment in reason of patients oneself or reason unknown though they are under treatment. 5.Improvement of the lifestyle and physical function: Decrease of smoking behavior, Decrease of excessive intake of alcohol, Appropriate range of BMI, Improvement of menstrual cycle.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 42years-old
• Gender: Female
• Exclude criteria: 1.The women who need in vitro fertilization or micro insemination medically. 2.The women who have already a history of infertility treatment in another hospital. 3.The women who have complications* that need treatment before infertility treatment start or at the same time. *Endometriosis, Uterine myoma, Ovarian cyst, Impaired glucose tolerance, Mental nervous system disease, Cervical zone cytodiagnosis abnormality, Premature ovarian insufficiency 4.The women who have a history of stillbirth or early neonatal death.

Related Information

• Primary Sponsor: St. Luke's International University Division of Women's Health and Midwifery
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology
• Secondary ID(s): 17-A006