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01.12.2014 | Research | Ausgabe 1/2014 Open Access

Reproductive Biology and Endocrinology 1/2014

Phase IV, open-label, randomized study of low-dose recombinant human follicle-stimulating hormone protocols for ovulation induction

Zeitschrift:
Reproductive Biology and Endocrinology > Ausgabe 1/2014
Autoren:
Gamal I Serour, Mohamed Aboulghar, Awatef Al Bahar, Jean-Noel Hugues, Khaled Esmat
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1477-7827-12-52) contains supplementary material, which is available to authorized users.

Competing interests

Gamal I Serour has received a grant from Al Azhar University. Jean-Noel Hugues has participated in previous international studies on products manufactured by Merck Serono. Khaled Esmat was an employee of Merck Serono Middle East FZ – LLC, Dubai, UAE (an affiliate of Merck KGaA, Darmstadt, Germany) at the time of the study. Mohamed Aboulghar and Awatef Al Bahar declare that they have no competing interests.

Authors’ contributions

All authors provided substantial contributions to conception and design, acquisition of data, analysis and interpretation of data, and revised the manuscript critically for important intellectual content. All authors read and approved the final manuscript.

Abstract

Background

This Phase IV, open-label, multicentre, randomized study (MEnTOR) compared two low-dose recombinant human follicle-stimulating hormone (r-hFSH) protocols for ovulation induction.

Methods

This study was conducted in six Middle Eastern countries between March 2009 and March 2011. Eligible women (18–37 years), with World Health Organization Group II anovulatory infertility, were randomized to receive r-hFSH (starting daily dose: 75 IU) as a chronic low-dose (CLD) (37.5 IU dose increase on Day 14) or low-dose (LD) (37.5 IU dose increase on Day 7) protocol if no follicles were ≥10 mm. The maximum r-hFSH daily dose permitted was 225 IU/day. The total length of ovarian stimulation could not exceed 35 days, unless ultrasound assessment suggested imminent follicular growth and maturation. Patients underwent only one treatment cycle. Primary endpoint: incidence of mono-follicular development. Secondary endpoints included: stimulation duration and rates of bi-follicular development; human chorionic gonadotrophin administration rate; clinical pregnancy; and cycle cancellation (owing to inadequate response). Adverse events (AEs) were recorded. The primary efficacy analysis was performed using data from all patients who received at least one dose of correct study medication, had at least one efficacy assessment, and no protocol violations at treatment start (CLD group, n = 122; LD group, n = 125).

Results

Mono-follicular development rates (primary endpoint) were similar in both groups (CLD: 56.6% [69/122] versus LD: 55.2% [69/125], p = 0.93; primary efficacy analysis population). Similarly, there were no significant differences between groups in bi-follicular development, clinical pregnancy or cycle cancellation (inadequate response) rates. In patients who received human chorionic gonadotrophin injections, the mean duration of stimulation was 13.7 days in the CLD group and 12.9 days in the LD group. Clinical pregnancy rates for those patients who received an hCG injection were similar in both groups (CLD: 20.2% [19/94] versus LD: 19.8% [18/91], p = 0.94; primary efficacy analysis population). Most AEs were mild in severity. Only one case of ovarian hyperstimulation syndrome was reported (mild; CLD group).

Conclusions

Efficacy and safety outcomes were similar for the two protocols.

Trial registration

Clinicaltrials.gov NCT01081626.
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