Does Luteal Phase Support Effect Pregnancy Rates in Intrauterine Insemination Cycles? A Prospective Randomised Controlled Study in a Tertiary Center

Abstract

Intrauterine insemination (IUI) is a common treatment for couples with subfertility. Clomiphene citrate, gonadotropins, and letrozole are used for ovulation induction in IUI cycles. It has been well documented that luteal support with exogenous progesterone after in vitro fertilization is associated with higher pregnancy and live birth rates. Yet, luteal phase support in IUI cycles has become a debatable issue. The aim of this prospective controlled study was to assess the effect of luteal phase vaginal progesterone supplementation on β-hCG positivity and clinical pregnancy rates in women undergoing IUI. This prospective controlled randomised study was conducted at a tertiary infertility center. 87 patients with unexplained infertility or male subfertility who were treated with IUI using gonadotropins were enrolled. Patients in the study group (n = 44) received luteal phase vaginal progesterone supplementation. Patients in the control group (n = 43) did not receive any luteal phase support. There was no statistical difference between two groups in terms of β-hCG positivity and clinical pregnancy rates. Our findings do not show any beneficial effect of luteal phase support in IUI cycles stimulated with gonadotropins. Although luteal phase support in IUI cycles stimulated with gonadotropins is widely adopted, there is a lack of robust evidence.

The definition of unexplained infertility: A systematic review

“…Of the remaining 375 papers, 117 did not classify a definition of unexplained infertility. As a result, a total of 258 primary research papers with full text available were included …”

Luteal Phase Support in Intrauterine Insemination Cycles: A Randomized Clinical Trial of Vaginal Versus Intramuscular Progesterone Administration

“…The results of some studies showed that LPS by vaginal progesterone administration did not improve the clinical pregnancy rate of stimulated IUI cycles when compared with no administration of LPS ( 7 , 8 ).…”

“…However, the role of luteal phase support (LPS) is not clear among women who are trying to conceive through ovarian stimulation with gonadotropins in an IUI cycle ( 5 ). Many prospective randomized studies have assessed the advantages of LPS with progesterone in stimulated IUI cycles, but the outcomes have not been consistent with several studies that indicate the benefits of such method ( 5 , 6 ) and others that reflect no favorable effects ( 7 , 8 ). Finally, several meta-analyses have proved that the use of progesterone to support luteal phase may be beneficial to patients receiving gonadotropins for ovulation induction in IUI cycles ( 9 – 11 ).…”

The efficacy and safety of luteal phase support with progesterone following ovarian stimulation and intrauterine insemination: A systematic review and meta-analysis

“…We identified fifteen published RCTs comparing progesterone luteal phase support after OS-IUI to placebo or no intervention which reported the outcomes of interest (9,19,24,25,(35)(36)(37)(38)(39)(40)(41)(42)(43)(44)(45). With respect to the previous review by Green et al, we identified three additional studies (36,43,45) that met the inclusion criteria specified by the authors but were not included in their review, and one newer study (39).For the present review, we had specified unexplained or mild male infertility as the population of interest; this led to the exclusion of the study by Yacizi et al (45), which included only women with PCOS. Our requirement that ITT, per participant data could be extracted resulted in exclusion of an additional two studies (36,42).…”

“…Nevertheless, several other studies included a relatively long mean duration of infertility (e.g. 4.8 years ( 19), 4.6 years ( 44)) or included patients with a minimum of two years of infertility (39,40) and failed to report a significant result independently.…”