Oral dydrogesterone along with vaginal micronized progesterone supplementation for luteal phase support in IVF patients, and its impact on pregnancy and live birth rates: a prospective randomized trial.

BACKGROUND

A normal luteal function is an essential factor for maintaining pregnancy; luteal phase deficiency decreases embryo implantation and pregnancy rate and increases the early miscarriage rate. In stimulated in vitro fertilization-embryo transfer (IVF-ET) patients, luteal phase support (LPS) is achieved by the exogenous supplementation with progesterone to increase endometrial receptivity and pregnancy. While several protocols exist, no commonly accepted protocol has been established for optimal luteal support after IVF-ET to date, the purpose of this study was to investigate the effect of two different luteal phase support protocols in patients undergoing assisted reproductive technologies.

METHODS

In a prospective open, randomized study conducted in a private IVF Unit a total of 700 infertile patients, undergoing in vitro fertilization treatment, were recruited for this study. All patients had a mild ovarian stimulation protocol with GnRH antagonist. The patients were randomized into two groups based on the type of luteal phase support route: Group A, control group (n = 310) patients received our routine LPS protocol which consists of the administration of 800 mg of micronized vaginal progesterone and Group B, study group, (n = 310) patients received a combination of oral dydrogesterone 20 mg and 90 mg of a gel of vaginal micronized progesterone Pregnancy rate, live birth rate, implantation rate and miscarriage rate were evaluated as primary endpoints. Statistical analysis was performed using JMP software (version 17; SAS, Inc., Cary, NC, USA). A P ≤ 0.05 was considered statistically significant.

RESULTS

No differences were observed between the two groups in terms of pregnancy rate (Group A 34,9% vs. Group B 35,7%), live birth rate (Group A 30,6% vs. Group B 29,2%), miscarriage rate (Group A 12% vs. Group B 18%) and implantation rate (Group A 18,6% vs. Group B 17,1%).

CONCLUSIONS

The combination of two different formulations of progesterone (vaginal and oral) for luteal phase support does not improve IVF outcomes when compared to the vaginal route of progesterone administration alone.

TRIAL REGISTRATION

The study has been retrospectively registered with the Clinical Trials registry reference number ISRCTN52148405 ( http://isrctn.org/ ).