Impact of luteal phase support with vaginal progesterone on the clinical pregnancy rate in intrauterine insemination cycles stimulated with gonadotropins: a randomized multicenter study

In this randomized controlled trial of gonadotropin-stimulated intrauterine insemination cycles, the clinical pregnancy rate was not statistically significantly higher after luteal phase support with vaginal progesterone gel than without support.

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Volume 106, Issue 6, Pages 1490-1495

Authors:

Karen Peeraer, M.D., Thomas D'Hooghe, M.D., Ph.D., Pascale Laurent, M.D., Sofie Pelckmans, M.D., Annick Delvigne, M.D., Ph.D., Annouschka Laenen, Ph.D., M. Welkenhuysen, Christine Wyns, M.D., Ph.D., Diane De Neubourg, M.D., Ph.D.

Abstract:

Objective

To evaluate the effect of luteal phase support (LPS) in intrauterine insemination (IUI) cycles stimulated with gonadotropins.

Design

Randomized multicenter trial.

Setting

Academic tertiary care centers and affiliated secondary care centers.

Patient(s)

Three hundred and ninety-three normo-ovulatory patients, <43 years, with body mass index ≤30 kg/m2, in their first IUI cycle, with at least one patent tube, a normal uterine cavity, and a male partner with total motile sperm count ≥5 million after capacitation.

Intervention(s)

Gonadotropin stimulation, IUI, randomization to LPS using vaginal progesterone gel (n = 202) or no LPS (n = 191).

Main Outcome Measure(s)

Clinical pregnancy rate, live-birth rate, miscarriage rate, and duration of the luteal phase.

Result(s)

The primary outcome, the clinical pregnancy rate, was not statistically different between the treatment group (16.8%) and the control group (11%) (relative risk [RR] 1.54; 95% confidence interval [CI], 0.89–2.67). Similarly, the secondary outcome, the live-birth rate, was 14.9% in the treatment group and 9.4% in the control group (RR 1.60; 95% CI, 0.89–2.87). The mean duration of the luteal phase was about 2 days longer in the treatment group (16.6 ± 2.2 days) compared with the control group (14.6 ± 2.5 days) (mean difference 2.07; 90% CI, 1.58–2.56).

Conclusion(s)

Although a trend toward a higher clinical pregnancy rate as well as live-birth rate was observed in the treatment group, the difference with the control group was not statistically significant.

Clinical Trial Registration Number

NCT01826747.


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Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.

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