Clomifene Citrate or Unstimulated Intrauterine Insemination Compared with Expectant Management for Unexplained Infertility: Pragmatic Randomised Controlled Trial

Overview

Journal BMJ

Specialty General Medicine

Date 2008 Aug 9

PMID 18687718

Citations 30

Authors

S Bhattacharya

K Harrild

J Mollison

S Wordsworth

C Tay

A Harrold

D McQueen

H Lyall

L Johnston

J Burrage

S Grossett

H Walton

J Lynch

A Johnstone

S Kini

A Raja

A Templeton

Affiliations

Soon will be listed here.

Abstract

Objective: To compare the effectiveness of clomifene citrate and unstimulated intrauterine insemination with expectant management for the treatment of unexplained infertility.

Design: Three arm parallel group, pragmatic randomised controlled trial.

Setting: Four teaching hospitals and a district general hospital in Scotland.

Participants: Couples with infertility for over two years, confirmed ovulation, patent fallopian tubes, and motile sperm.

Intervention: Expectant management, oral clomifene citrate, and unstimulated intrauterine insemination.

Main Outcome Measures: The primary outcome was live birth. Secondary outcome measures included clinical pregnancy, multiple pregnancy, miscarriage, and acceptability.

Results: 580 women were randomised to expectant management (n=193), oral clomifene citrate (n=194), or unstimulated intrauterine insemination (n=193) for six months. The three randomised groups were comparable in terms of age, body mass index, duration of infertility, sperm concentration, and motility. Live birth rates were 32/193 (17%), 26/192 (14%), and 43/191 (23%), respectively. Compared with expectant management, the odds ratio for a live birth was 0.79 (95% confidence interval 0.45 to 1.38) after clomifene citrate and 1.46 (0.88 to 2.43) after unstimulated intrauterine insemination. More women randomised to clomifene citrate (159/170, 94%) and unstimulated intrauterine insemination (155/162, 96%) found the process of treatment acceptable than those randomised to expectant management (123/153, 80%) (P=0.001 and P<0.001, respectively).

Conclusion: In couples with unexplained infertility existing treatments such as empirical clomifene and unstimulated intrauterine insemination are unlikely to offer superior live birth rates compared with expectant management.

Trial Registration: ISRCT No: 71762042.

Citing Articles

Improved reproductive outcomes in normogonadotropic oligomenorrheic women undergoing ovarian stimulation with intrauterine insemination: a retrospective cohort analysis of real-world data.

Li S, Long Y, Wang C, Yang R, Lv J, Chen Z Front Endocrinol (Lausanne). 2024; 15:1441796.

PMID: 39444447 PMC: 11496073. DOI: 10.3389/fendo.2024.1441796.

The web-based Pleasure&Pregnancy programme in the treatment of unexplained infertility: a randomized controlled trial.

Dreischor F, Dancet E, Lambalk C, van Lunsen H, Besselink D, van Disseldorp J Hum Reprod. 2024; 39(12):2711-2721.

PMID: 39352942 PMC: 11630088. DOI: 10.1093/humrep/deae220.

In vitro fertilisation for unexplained subfertility.

Sunkara S, Kamath M, Pandian Z, Gibreel A, Bhattacharya S Cochrane Database Syst Rev. 2023; 9:CD003357.

PMID: 37753821 PMC: 10523437. DOI: 10.1002/14651858.CD003357.pub5.

Evidence-based guideline: unexplained infertility†.

Romualdi D, Ata B, Bhattacharya S, Bosch E, Costello M, Gersak K Hum Reprod. 2023; 38(10):1881-1890.

PMID: 37599566 PMC: 10546081. DOI: 10.1093/humrep/dead150.

Pharmacotherapy for Infertility in Ghana: A Prospective Study on Prescription Patterns and Treatment Outcomes among Women undergoing Fertility Treatment.

Arhin S, Mensah K, Agbeno E, Henneh I, Azize D, Boateng A Curr Ther Res Clin Exp. 2023; 99:100711.

PMID: 37519419 PMC: 10372179. DOI: 10.1016/j.curtheres.2023.100711.

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