Controlled ovarian stimulation and intrauterine insemination or in vitro-fertilisation for the first line treatment of unexplained infertility

Not Applicable

Completed

• Conditions: Infertility; Best first line treatment options for unexplained infertility; Pregnancy and Childbirth

• Registration Number: ISRCTN43430382
• Lead Sponsor: Homerton University Hospital (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-08
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 320

Inclusion Criteria

1. Couples with female partner's age between 23- 37 years
2. Diagnosed with unexplained infertility at the time of first treatment
3. Inability to conceive following a minimum of one year of unprotected intercourse
4. In the presence of normal semen analysis, proof of regular ovulatory cycles with a day 3 follicle stimulating hormone (FSH)<10IU/L
5. Two patent tubes and a normal uterine cavity on hysterosalpingography (HSG)

Exclusion Criteria

1. Female partner aged 37 years or more
2. People with physical disability or psychosexual problems who find difficulty in achieving vaginal intercourse
3. Couples in a same sex relationship (as these do not fall into the definition of unexplained infertility)
4. Couples where the male/female is HIV positive, as they would need specific consideration to methods of conception
5. Couples who have had no previous IUI or IVF treatment for infertility

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Singleton live birth rate is assessed using medical record review

Secondary Outcome Measures

Name	Time	Method
1. Clinical pregnancy rate is assessed using medical record review<br>2. Multiple pregnancy rates is assessed using medical record review