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

Abstract

BackgroundThis Phase IV, open-label, multicentre, randomized study (MEnTOR) compared two low-dose recombinant human follicle-stimulating hormone (r-hFSH) protocols for ovulation induction.MethodsThis 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).ResultsMono-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).ConclusionsEfficacy and safety outcomes were similar for the two protocols.Trial registrationClinicaltrials.gov NCT01081626.

Síndrome de ovario poliquístico

“…La incidencia de gemelos es de alrededor del 10 % y los trillizos del 1 %. 9 Sin embargo el clomifeno tiene inconvenientes, incluida su poca eficacia general (solo una tasa de 22 % de nacidos vivos con hasta seis ciclos de clomifeno reportado en algunos casos, una tasa de embarazo múltiple relativamente alta (3 a 8 %) en comparación con la tasa asociada con una concepción no asistida (<1 %) y un perfil de efectos secundarios indeseables, que incluye cambios de humor y bochornos. 4 El objetivo de la inducción de la ovulación es la maduración regular de un óvulo por ciclo para evitar el embarazo múltiple, se recomienda además que las mujeres no tomen clomifeno por más de seis meses.…”

The effect of Bushen Culuan Decoction on anovulatory infertile women among 6 different diseases: a study protocol for a randomized, double-blinded, positively controlled, adaptive multicenter clinical trial

“…Anovulation is one of the main causes of female infertility, contributing to 25–30% of all female infertility [ 1 ]. The function of the hypothalamic-pituitary-ovarian axis (HPOA) can be disturbed by psychentonia, over-fatigue, and diseases related to the hypothalamus, pituitary, ovary, thyroid or adrenal gland, and malfunction of the HPOA will lead to follicle hypoplasia, delayed follicle maturation, or anovulation [ 2 ].…”

Efficacy of Asparagus recemosus (Satavar) in stimulating follicular growth and ovulation in anovulatory infertility: a randomized controlled trial

“…3,4 The causes of anovulation include hypothalamic failure, hyperprolactinaemia, polycystic ovarian syndrome, premature ovarian failure, subclinical hypothyroidism, adrenal failure and obesity. Out of these disorders, polycystic ovarian syndrome is the commonest, easily diagnosed and most treatable cause of an anovulatory infertility 5 accounting for 75% of cases.…”