Comparing Ovarian Stimulation for Assisted Reproduction With Two Different Forms of Pituitary Suppression

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to assess the non-inferiority of a multidose GnRH antagonist (cetrorelix) regimen to a GnRH agonist (triptorelin) long protocol in young infertile women undergoing ovarian stimulation with Pergoveris 150 I.U./75 I.U. (r-hFSH/ r-hLH) for ICSI treatment because of male infertility.

To assess the efficacy of ovarian stimulation using either a GnRH antagonist (cetrorelix) or a GnRH agonist (triptorelin) long protocol in infertile women with good prognosis and to determine the safety of ovarian stimulation.

Subsample analysis: in 10 patients of each of both arms, serum samples will be collected daily during the stimulation period and be stored frozen at -70 °C. The following hormone concentrations will be measured later in single assay batches: LH, FSH, oestradiol, progesterone, androstenedione, testosterone, inhibin A, inhibin B, AMH.

Multinational, multicentre, open label, randomized, 2-arm parallel-group phase IV study. Eligible patients will be randomly allocated to one of the two groups: the agonist group will receive Decapeptyl® 0.1 mg (triptorelin) starting in the mid-luteal phase of the natural cycle until downregulation until the day of ovulation induction. The antagonist group will receive cetrorelix 0.25 mg from stimulation day 6 to ovulation induction. In both groups, Pergoveris® 150 I.U./75 I.U. (r-hFSH/r-hLH) will be used for ovarian stimulation from cycle day 2 to ovulation induction.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Basel, Switzerland; University of Basel
• Collaborator: Merck Serono International SA
• Treatments: Cetrorelix; Deslorelin; Follicle Stimulating Hormone; Prolactin Release-Inhibiting Factors; Triptorelin Pamoate

Criteria

Inclusion Criteria:

Female patients younger than 36 years of age with an indication for ICSI:

• 20 to 35 years inclusive

• body mass index between 19 and 30 kg/m2

• indication for ICSI due to male infertility

• cycle length 27 to 32 days

• presence of both ovaries

• rubella immunity

• written informed consent

Exclusion Criteria:

• age > 35 years

• pregnancy and breast feeding

• ovarian endometriosis

• uterine fibroids interfering with endometrial proliferation

• sperm retrieval from the epididymis or the testis

• more than one previous ART treatment with pregnancy

• known or suspected hypersensitivity to active substances

• clinically relevant systemic disease

• previous enrollment to this study

• know or suspected non-compliance, drug or alcohol abuse