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Therapeutics Ovulation Agents

Tamoxifen is Better than Low-Dose Clomiphene or Gonadotropins in Women with Thin Endometrium (<7 mm) after Clomiphene in Intrauterine Insemination Cycles: A Prospective Study

Sharma S, Rani G, Bose G, Saha I, Bathwal S, Chakravarty BN

Published April 24, 2018 Journal of Human Reproductive Sciences, 11(1), 34-39
DOI 10.4103/jhrs.JHRS_9_17 PMID 29681714 PMC PMC5892102

RRM Academy Synopsis

Tamoxifen had more live births than low-dose clomiphene in thin lining

Women with a thin lining after clomiphene had more live births on tamoxifen or gonadotropin shots than on lower-dose clomiphene, a 2018 observational study of 502 women in India found. About 12 out of 100 women on tamoxifen in this study had a live birth. On lower-dose clomiphene, about 3 out of 100 did.

Key Findings

  • Live births: 22 of 179 women on tamoxifen (12.2%), 18 of 141 on gonadotropins (12.7%), 6 of 182 on lower-dose clomiphene (3.2%). Tamoxifen and gonadotropins did not differ significantly in live births.
  • Pregnancy rates were 14.52% with tamoxifen, 14.89% with gonadotropins and 4.94% with lower-dose clomiphene. The clomiphene group's pregnancy rate was significantly lower (P < 0.002).
  • Lining thickness was highest with gonadotropins, then tamoxifen, then lower-dose clomiphene (each comparison P < 0.001). The tamoxifen group had fewer follicles: 1.3, against 2.2 with clomiphene and 2.3 with gonadotropins.
  • In women with polyendocrine metabolic ovarian syndrome (PMOS), formerly polycystic ovary syndrome (PCOS), 53 of 96 tamoxifen cycles (55.2%) were cancelled for inadequate response. Clomiphene cycles: 16.4% cancelled. Gonadotropin cycles: 12.9%.
  • Multiple pregnancies numbered 1 with clomiphene, none with tamoxifen and 3 with gonadotropins. The text reports three twin pregnancies in the gonadotropin group, and the paper lists the differences as not significant.

Interpretation

The study is a prospective observational study at one private center. Women entered the three groups in serial order without randomization, so unmeasured differences between groups could shape the results. Age, body mass index and baseline hormone levels were comparable across groups. Live births were few: 6, 22 and 18. Every woman had already shown a thin lining on clomiphene. Women with endometriosis were excluded. The authors call tamoxifen promising, describe it as less effective in women with PCOS who responded well to clomiphene, and call for larger trials.

RRM Context

Clomiphene can thin the uterine lining. This study tests tamoxifen and gonadotropins as the next step. Restorative reproductive medicine asks an earlier question: why does ovulation need induction at all? The paper lists male factor, ovulation problems and unexplained infertility as reasons for treatment, and compares only drug groups. A Cochrane review the paper cites found similar pregnancy and live birth rates with clomiphene and tamoxifen in PCOS.

Our editorial summary of this paper, not the article's abstract.

Abstract

Aim

Gonadotropin stimulation is used as the second line of treatment in patients with thin endometrium following clomiphene citrate (CC) administration, which is associated with higher cost, multiple births, and ovarian hyperstimulation syndrome. Tamoxifen (TMX), a selective estrogen receptor modulator, acts as an agonist on the endometrium. The objective of the present study was to compare the efficacy of low-dose CC, TMX, and gonadotropins in women with thin endometrium (<7 mm) following Clomiphene in intrauterine insemination (IUI) cycles.

Design and Setting

A prospective observational study between December 2011 and June 2013 was carried out in a tertiary infertility center.

Methods

Women (n = 502) undergoing IUI with endometrium <7 mm after 100 mg CC were included in the study and divided into three treatment groups. Women in Group A (n = 182, cycles = 364) received clomiphene (50 mg/day from day 3 to 7), Group B (n = 179, cycles = 342) received TMX (40 mg/day from day 3 to 7), and Group C (n = 141, cycles = 226) received continuous urine-derived follicle-stimulating hormone 75-150 IU from day 3 onward until human chorionic gonadotropin injection. Endometrial thickness (ET), pregnancy rate, and live birth rate were considered as main outcome measures.

Statistical Analysis

Multiple comparisons using one-way ANOVA and Schiff's test were performed.

Results

Pregnancy and live birth rate were significantly higher (P < 0.004) in TMX and gonadotropin groups compared to clomiphene. A number of follicles in the TMX group were found to be lower (P < 0.001) compared to other two groups. In polycystic ovary syndrome patients, ovulation induction with TMX resulted in inadequate response in more than half of the cycles.

Conclusions

TMX can improve ET and live birth rate in patients with thin endometrium after clomiphene.

Topics

By this author

Related research

Therapeutics › Ovulation Agents › Selective Estrogen Receptor Modulators · Assisted Reproduction › Outcomes and Effectiveness › Live Birth Rates · Infertility › Uterine Factor › Endometrial Receptivity
Sunita Sharma, Geetha Rani, Gunja Bose, Indranil Saha, Sikha Bathwal
S Sharma, G Rani, G Bose, I Saha, S Bathwal
PMID 29681714 29681714 DOI 10.4103/jhrs.JHRS_9_17 10.4103/jhrs.JHRS_9_17 Sharma et al. 2018, Sharma 2018

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