None listed
Conditions
Brief summary
The favourable effect of endometrial biopsy in women undergoing embryo transfer or natural conception indicates that the biopsy somehow enhances the endometrial receptivity in a group of women whose endometrium is otherwise not adequately receptive to an implanting embryo. As it is likely that poor endometrial receptivity is at least partly contributing to the experienced infertility in cases of unexplained infertility, endometrial biopsy may also be beneficial for these couples. Unfortunately, research concerning the utility of endometrial biopsy in couples with unexplained infertility who are trying to conceive spontaneously is sparse. We plan to address the current limitations by conducting a pragmatic, double-blind, randomised controlled trial, of endometrial biopsy in couples with unexplained infertility.
Interventions
Women will undergo a single endometrial pipelle biopsy performed between days 1 and 12 of a 28 day menstrual cycle. For women with shorter or longer cycles, this time frame can be adjusted accordingly.
Sponsors
Auckland District Health Board
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
1. Couples having regular unprotected sexual intercourse in a relationship where pregnancy is desired 2. Women is between 18-42 years of age at the time of randomisation 3. Women who are diagnosed with unexplained infertility: normal ovulation (21-35 day menstrual cycles with variation <8 days and luteal phase progesterone test), normal semen analysis (progressive motility atleast 32%, volume at least 1.5ml, conc. at least 15million/ml) or total motile count equal to or more than 10 million 4. Have either a) at two ovaries and two probably patent fallopian tubes (confirmed by hysteroscopy or HSG) or b) a previous intrauterine pregnancy, and no subsequent surgery or ectopic pregnancy that may reduce tubal patency or ovarian function 5. A body mass index (BMI) of equal to or less than 35 6. Have a negative cervical PAP smear within the last 3 years 7. Be willing to have regular sexual intercourse following the procedure in the month of the procedure, and for two months following the procedure (or until pregnancy occurs)
Exclusion criteria
1. Have had any disruptive instrumentation within the uterine cavity (e.g. hysteroscopy, hysterosalpingogram, laparoscopy, surgically managed miscarriage or endometrial biopsy) within three months prior to day one of the first study menstrual cycle, or planning to undergo a procedure involving disruptive instrumentation at any stage during the study. 2. Entered previously into this study or participation in another trial in the last 30 days 3. Any contraindication to endometrial biopsy or being pregnant and/or carrying a pregnancy to term
Outcome results
None listed