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Ovulation induction with a starting dose of 50 IU of recombinant follicle stimulating hormone in WHO group II anovulatory women: the IO-50 study, a prospective, observational, multicentre, open trial

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Abstract:

Objective

To assess the efficacy and safety in clinical practice of a low dose regimen of 50 IU of recombinant follicle stimulating hormone in induction of ovulation. Design

Prospective, observational, non-comparative, open, multicentre study. Setting

Eighty-eight infertility clinics and teaching hospital fertility units throughout Spain. Population

Women with normogonadotrophic chronic anovulation (WHO group II) with or without echographic diagnosis of polycystic ovary syndrome. Methods

Low dose step-up protocol of recombinant follicle stimulating hormone administration (follitropin beta, Puregon) with a starting dose of 50 IU and weekly increments according to follicular response monitored prospectively by transvaginal ultrasonography. Patients were followed for a minimum of one cycle and a maximum of six. Main outcome measures

Rate and size of follicular growth, cumulative ovulation rate, follicle stimulating hormone doses and duration of treatment, pregnancy and cycle cancellation rate, ovarian hyperstimulation syndrome and multiple pregnancy. Results

A total of 945 treatment cycles were evaluated. In 817 cycles, ovulation was induced with human chorionic gonadotrophin (hCG) and in 501 (61.3%) unifollicular development (a follicle of ≥18 mm) was achieved. A total of 128 cycles (13.5%) were cancelled because of ovarian hyper-responsiveness or spontaneous ovulation. The cumulative ovulation rate (confirmed by mid-luteal serum progesterone concentrations) after six treatment cycles was 84%. There were 136 clinical pregnancies (14.4% pregnancies per cycle). The cumulative pregnancy rate after six treatment cycles was 53.1%. Eight twin pregnancies occurred. Thirteen women miscarried and there were two cases of ectopic pregnancies. The median of average daily doses of follitropin beta in all cycles was 50 IU. Between 68% and 86% of patients received treatment with follitropin beta for a maximum of 14 days. Ovarian hyperstimulation syndrome occurred in 64 (6.8%) cases but no case of severe ovarian hyperstimulation developed. Conclusions

Low dose regimen of 50 IU of recombinant follicle stimulating hormone (Puregon) is efficient, safe and well tolerated for inducing follicular development in WHO group II anovulatory women.

Document Type: Research Article

DOI: https://doi.org/10.1111/j.1471-0528.2003.02290.x

Affiliations: 1: Department of Obstetrics and Gynaecology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain 2: Department of Obstetrics and Gynaecology, Hospital 12 de Octubre, Madrid, Spain 3: Department of Obstetrics and Gynaecology, Hospital La Fe, Valencia, Spain 4: Department of Obstetrics and Gynaecology, Hospital Universitario de Valme, Seville, Spain 5: Department of Obstetrics and Gynaecology, Málaga FIV, Spain 6: Department of Obstetrics and Gynaecology, Complejo Hospitalario Juan Canalejo, A Coruña, Spain 7: Department of Obstetrics and Gynaecology, Hospital Miguel Servet, Zaragoza, Spain 8: Department of Obstetrics and Gynaecology, Hospital de Cruces, Barakaldo, Bizkaia, Spain

Publication date: 2003-12-01

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