Nandi 2015.

Trial name or title	Controlled ovarian stimulation and intrauterine insemination or in vitro fertilisation as first‐line treatment for unexplained infertility: a randomised controlled trial
Methods	Randomised controlled trial (RCT)
Participants	Inclusion criteria Age of female partner between 23 and 37 years Diagnosis of unexplained infertility at time of first treatment Inability to conceive following minimum of 1 year of unprotected intercourse In the presence of normal semen analysis, proof of regular ovulatory cycles with day 3 follicle‐stimulating hormone (FSH) < 10 IU/L 2 patent tubes and normal uterine cavity on hysterosalpingography (HSG) Exclusion criteria Female partner ≥ 37 years of age Physical disability or psychosexual problems with difficulty achieving vaginal intercourse Same sex relationship (as these do not fall under the definition of unexplained infertility) Male/female is human immunodeficiency virus (HIV) positive, as these couples would need specific consideration regarding methods of conception No previous intrauterine insemination (IUI) or in vitro fertilisation (IVF) treatment for infertility
Interventions	Randomisation is performed by an independent worker in blocks of 10 and distributed in individual consecutively numbered opaque envelopes. Participants will be randomly assigned to 2 groups: Group 1: controlled ovarian hyperstimulation (COH) + IUI. In COH + IUI group, controlled ovarian hyperstimulation can be performed with daily subcutaneous injections of 75 IU FSH, from day 3 to 4 of menstrual cycle onwards. If ≥ 3 follicles > 16 mm develop, the cycle would be cancelled. Single insemination will be done Group 2: IVF In IVF group, women will undergo controlled ovarian hyperstimulation after downregulation with gonadotropin releasing hormone (GnRH) agonist in a long protocol starting on day 2. COH is started with FSH, with doses ranging from 150 to 450 IU, depending on initial anti‐Mullerian hormone (AMH) level as decided by attending clinician. Day of embryo transfer will be decided by embryologist base
Outcomes	Primary outcome: singleton live birth Secondary outcomes: clinical pregnancy rate, multiple pregnancy rate
Starting date	17/6/2013
Contact information	Anupa Nandi Homerton Fertility Unit Homerton Hospital E9 6SR London United Kingdom
Notes	http://isrctn.com/ISRCTN43430382