A randomized prospective study comparing pregnancy rates after clomiphene citrate and human menopausal gonadotropin before intrauterine insemination

René Ecochard; Claudine Mathieu; Dominique Royere; Gilles Blache; Muriel Rabilloud; Jean Claude Czyba

doi:10.1016/s0015-0282(99)00474-4

Therapeutics Ovulation Agents

A randomized prospective study comparing pregnancy rates after clomiphene citrate and human menopausal gonadotropin before intrauterine insemination

Ecochard R, Mathieu C, Royere D, Blache G, Rabilloud M, Czyba JC

Published January 2000 Fertility and sterility

DOI 10.1016/s0015-0282(99)00474-4 PMID 10632419

RRM Academy Synopsis

Clomiphene and hMG showed no significant pregnancy gap before IUI

A randomized trial of 58 women under 39 found that pregnancy rates did not differ significantly between clomiphene citrate and hMG before IUI. Each woman received both drugs, two cycles of each, in randomized order. Of 174 cycles analyzed, about 14 out of 100 clomiphene cycles and 7 out of 100 hMG cycles ended in pregnancy.

Study at a glance, randomized trial of 58 women: Clomiphene and hMG showed no significant pregnancy gap. Source: Ecochard R et al., 2000, PMID 10632419.

Key Findings

Cycle fecundity was 11.11% (9 of 81 cycles) in women given clomiphene citrate (CC) first and 10.75% (10 of 93) in women given human menopausal gonadotropin (hMG) first, a nonsignificant difference.
Across 174 cycles, 13 of 90 CC cycles (14.44%) and 6 of 84 hMG cycles (7.14%) ended in pregnancy. The difference was not statistically significant.
Life-table cumulative pregnancy after 4 cycles was 35.2% and 44.0% for the two order groups (P=.9), and 51.44% for CC cycles against 25.40% for hMG cycles (P=.4).
The trial recorded 19 pregnancies. Three ended in spontaneous miscarriage (15.6% of pregnancies), all in CC cycles. Pregnancy occurred in 10.9% of cycles overall.
By diagnosis, pregnancy occurred in 5 of 13 women (38%) with female factor, 12 of 33 (36%) with male factor, and 2 of 12 (17%) with unexplained infertility (P=0.41).

Interpretation

Each woman in this randomized prospective trial received both drugs in a randomly assigned order, so each woman served as her own comparison. The authors calculated that 224 cycles were required to detect a difference with 80% power, and 174 were analyzed. They state that the low hMG success rate may partly explain the lack of power. They also state that the moderate, unadjusted hMG dose may have understated hMG results to some degree. The trial excluded women over 39 and women who were not ovulating, and male factor was overrepresented. The authors suggest that CC is an effective alternative to hMG in this population.

RRM Context

Restorative reproductive medicine finds the cause in both partners and treats it. Stimulation with insemination goes around that cause. Here, 33 of 58 couples had male factor infertility and 12 had unexplained infertility. Restorative clinicians see the second group as undiagnosed.

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

Abstract

Objective

To determine whether hMG offers an advantage over clomiphene citrate (CC) in achieving pregnancy after IUI with husband's sperm.

Design

Randomized prospective trial.

Setting

Infertility patients in a university teaching hospital.

Patients

Fifty-eight women under 39 years old undergoing ovulation induction before IUI.

Interventions

The women were assigned randomly to one of two treatment groups. Patients in group I (CCHH) received CC for the first two cycles and hMG for the last two cycles. Patients in group II (HHCC) received hMG for the first two cycles and CC for the last two cycles.

Main Outcome Measures

Cycle fecundity rates for the two treatment modalities were compared statistically with use of life-table analysis.

Results

Of the 174 cycles studied, overall cycle fecundity rate was 11.11 (9 of 81 cycles) in the CCHH group and 10.75 (10 of 93 cycles) in the HHCC group. The difference was not statistically significant. The cycle fecundity rate was 14.44% (13 of 90 cycles) for cycles with CC and 7.14% (6 of 84) with hMG. The difference was not statistically significant.

Conclusions

These data suggest that CC is an effective alternative to hMG in the population examined.

Topics

Therapeutics › Ovulation Agents › Selective Estrogen Receptor Modulators · Assisted Reproduction › Outcomes and Effectiveness › Cumulative Versus Per Cycle Reporting · Infertility › Ovulation Induction › Clomiphene Citrate

René Ecochard, Claudine Mathieu, Dominique Royere, Gilles Blache, Muriel Rabilloud, Jean Claude Czyba

R Ecochard, C Mathieu, D Royere, G Blache, M Rabilloud, J Czyba

PMID 10632419 10632419 DOI 10.1016/s0015-0282(99)00474-4 10.1016/s0015-0282(99)00474-4 Ecochard et al. 2000, Ecochard 2000

A randomized prospective study comparing pregnancy rates after clomiphene citrate and human menopausal gonadotropin before intrauterine insemination

Clomiphene and hMG showed no significant pregnancy gap before IUI

Key Findings

Interpretation

RRM Context

Abstract

Topics

By this author

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